natgillin/translations-raw huggingface dataset:
I den femte undersøgelse blev virkningen af Mirapexin sammenlignet med virkningen af levodopa hos 300 patienter med sygdom i tidligt stadium.
The fifth study compared the effects of Mirapexin with those of levodopa in 300 patients with early disease.
Behandlingens virkning blev hovedsagelig bedømt på den andel af patienterne, der havde bevægelsessymptomer.
Its main measure of effectiveness was the proportion of patients who had movement symptoms.
I alle undersøgelserne blev dosis af Mirapexin gradvis sat op i løbet af seks til ti uger, før der blev anvendt en stabil dosis.
In all studies, Mirapexin doses were increased gradually over six to ten weeks before being maintained at a stable dose.
Mirapexin blev desuden anvendt i to hovedundersøgelser af patienter med restless legs syndrome, Den første undersøgelse omfattede 344 patienter.
Mirapexin has also been studied in two main studies of patients with restless legs syndrome.
Her blev virkningerne af tre forskellige doser af Mirapexin sammenlignet med virkningerne af placebo.
The first included 344 patients and compared the effects of three doses of Mirapexin with those of placebo.
Virkningen blev hovedsagelig bedømt på bedringen i symptomerne fra undersøgelsens start til dens slutning, målt på to standardskalaer.
The main measure of effectiveness was the improvement in symptoms between the start and end of the study, measured using two standard scales.
Her blev virkningen af at fortsætte på Mirapexin sammenlignet med virkningen af at skifte til placebo.
The other study included 150 patients who took Mirapexin for six months, and compared the effects of remaining on Mirapexin or switching to placebo.
I undersøgelsen af patienter med fremskreden Parkinsons sygdom var der større bedring hos de patienter, der fik 24 ugers behandling med Mirapexin i fast dosering, end hos dem, der fik placebo.
In the study of patients with advanced Parkinson’ s disease, patients taking Mirapexin had larger improvements after 24 weeks of steady-dose treatment than those taking placebo.
Tilsvarende resultater sås i de tre første undersøgelser af Parkinsons sygdom i tidligt stadium, hvor der var større bedring efter fire eller 24 uger.
Similar results were seen in the first three studies of early Parkinson’ s disease, with greater improvements after four or 24 weeks.
Efter 21 måneder var der færre af de patienter, der fik Mirapexin, som havde bevægelsessymptomer end dem, der fik levodopa:
When compared with levodopa, fewer of the patients taking Mirapexin had movement symptoms after 21 months:
28% af de patienter, der fik Mirapexin, havde symptomer (42 ud af 151), sammenholdt med 51% af de patienter, der fik levodopa (76 ud a 150).
28% of the patients taking Mirapexin had symptoms (42 out of 151) compared with 51% of the patients taking levodopa (76 out of 150).
I den første undersøgelse af restless legs syndrome sås et fald i symptomscore på mellem 12, 8 og 14, 0 point efter 12 uger hos patienter, der fik Mirapexin, sammenholdt med et fald på 9, 3 point hos de patienter, der fik placebo.
In the first study of restless legs syndrome, symptom scores fell by between 12.8 and 14.0 points after 12 weeks in patients taking Mirapexin, compared with a fall of 9.3 points in the patients taking placebo.
23 point.
Scores were around 23 points at the start of the study.
Forskellen mellem placebo og Mirapexin var størst efter fire uger, hvorefter den blev mindre.
The difference between placebo and Mirapexin was greatest after four weeks before getting smaller.
Desuden var andelen af patienter, hvis symptomer bedredes, større i Mirapexin- gruppen.
More patients taking Mirapexin also had an improvement in symptoms.
Resultaterne af den anden undersøgelse var ikke tilstrækkelige til at bevise, at Mirapexin var effektivt ved langtidsbehandling.
The results of the other study were insufficient to prove the long- term effectiveness of Mirapexin.
Den hyppigste bivirkning ved Mirapexin (som ses hos flere end 1 ud af 10 patienter) er kvalme.
The most common side effect with Mirapexin (seen in more than 1 patient in 10) is nausea (feeling sick).
Hos patienter med Parkinsons sygdom er de øvrige bivirkninger, som optræder hos flere end 1 ud af 10 patienter, svimmelhed, dyskinesi (ufrivillige bevægelser), somnolens (søvnighed) og hypotension (lavt blodtryk).
In patients with Parkinson’ s disease, the other side effects seen in more than 1 patient in 10 are dizziness, dyskinesia (difficulty controlling movement), somnolence (sleepiness) and hypotension (low blood pressure).
Den fuldstændige liste over de indberettede bivirkninger ved Mirapexin fremgår af indlægssedlen.
For the full list of all side effects reported with Mirapexin, see the Package Leaflet.
Mirapexin bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for pramipexol eller andre af indholdsstofferne.
Mirapexin should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Mirapexin opvejer risiciene til behandling af tegn og symptomer på idiopatisk Parkinsons sygdom, anvendt enten alene eller i kombination med levodopa, og til behandling af moderat til svært idiopatisk restless legs
The Committee for Medicinal Products for Human Use (CHMP) decided that Mirapexin’ s benefits are greater than its risks for the treatment of the signs and symptoms of idiopathic Parkinson’ s disease alone or in combination with levodopa, and for the treatment of moderate to severe idiopathic restless legs syndrome in dosages up to 0.54 mg of base.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Mirapexin.
The Committee recommended that Mirapexin be given marketing authorisation.
Andre oplysninger om Mirapexin:
2/ 3 Other information about Mirapexin:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mirapexin den 23. februar 1998.
The European Commission granted a marketing authorisation valid throughout the European Union for Mirapexin on 23 February 1998.
Markedsføringstilladelsen blev fornyet den 23. februar 2003 og den 23. februar 2008.
The marketing authorisation was renewed on 23 February 2003 and on 23 February 2008.
Den fuldstændige EPAR for Mirapexin findes her.
The full EPAR for Mirapexin can be found here.
EU- nummer
Packaging
Særnavn
Mirapexin
Lægemiddelform
EU/ 1/ 97/ 051/ 002
Indgivelsesvej
EU/ 1/ 97/ 051/ 003
Emballage
Mirapexin
Pakningsstørrelse
EU/ 1/ 97/ 051/ 004
EU/ 1/ 97/ 051/ 001 EU/ 1/ 97/ 051/ 002 EU/ 1/ 97/ 051/ 003 EU/ 1/ 97/ 051/ 004 EU/ 1/ 97/ 051/ 005 EU/ 1/ 97/ 051/ 006 EU/ 1/ 97/ 051/ 009 EU/ 1/ 97/ 051/ 010 EU/ 1/ 97/ 051/ 011 EU/ 1/ 97/ 051/ 012
EU/ 1/ 97/ 051/ 006
Mirapexin Mirapexin Mirapexin Mirapexin Mirapexin Mirapexin Mirapexin Mirapexin Mirapexin Mirapexin
Blister (polyamide/ aluminium/ PVC)
0. 088 mg 0. 088 mg 0. 18 mg 0. 18 mg 0. 7 mg 0. 7 mg 1. 1 mg 1. 1 mg 3. 5 mg 3. 5 mg
Blister (polyamide/ aluminium/ PVC)
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Blister (polyamide/ aluminium/ PVC)
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use
Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC)
Blister (polyamide/ aluminium/ PVC)
30 tabletter 100 tabletter 30 tabletter 100 tabletter 30 tabletter 100 tabletter 30 tabletter 100 tabletter 30 tabletter 100 tabletter
Blister (polyamide/ aluminium/ PVC)
Mirapexin 0, 088 mg tabletter
MIRAPEXIN 0.088 mg tablets
Mirapexin 0, 088 mg tabletter indeholder 0, 088 mg pramipexolbase (som 0, 125 mg pramipexol dihydrochloridmonohydrat).
MIRAPEXIN 0.088 mg tablets contain 0.088 mg of pramipexole base (as 0.125 mg of pramipexole dihydrochloride monohydrate).
Bemærk venligst:
Please note:
Her udtrykkes doseringen af pramipexol som pramipexolbase.
Pramipexole doses as published in the literature refer to the salt form.
Da der i litteraturen refereres til doser af pramipexol i saltformen, er pramipexolsalt desuden anført i parentes.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Alle tabletter er hvide og præget med en kode.
All tablets are white and have a code embossed.
Styrke (mg salt) 0, 125 0, 25 0, 5 1, 0 1, 5
Strength (mg salt) 0.125 0.25 0.5 1.0 1.5
Beskrivelse flad, rund, 6 mm i diameter, ingen delekærv flad, oval, 7, 86 x 5, 63 mm, delekærv på begge sider flad, oval, 10, 59 x 7, 59 mm, delekærv på begge sider flad, rund, 9 mm i diameter, delekærv på begge sider flad, rund, 11 mm i diameter, delekærv på begge sider
Appearance flat, round, 6 mm diameter, no score flat, oval, 7.86 x 5.63 mm, scores on both sides flat, oval, 10.59 x 7.59 mm, scores on both sides flat, round, 9 mm diameter, scores on both sides flat, round, 11 mm diameter, scores on both sides
Alle tabletter kan deles i to lige store dele (undtagen 0, 088/ 0, 125 mg tabletter).
All tablets can be divided into equal halves (with the exception of the 0.088/ 0.125 mg tablet).
Mirapexin kan gives, som monoterapi eller i kombination med levodopa i hele sygdomsforløbet herunder i de sene stadier, når effekten af levodopa klinger af eller bliver ustabil, og svingninger i den terapeutiske effekt opstår.
MIRAPEXIN is indicated 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).
4. 2).
MIRAPEXIN is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2.).
Parkinsons sygdom
Parkinson’ s disease
Tabletterne kan både tages sammen med mad og alene og synkes med vand.
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Initial dosis Dosis skal øges gradvist hver 5. - 7. dag fra en startdosis på 0, 264 mg base (0, 375 mg salt) / døgn.
Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
Ved optitrering skal dosis afpasses mellem maksimal terapeutisk virkning og uacceptable bivirkninger.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
2 Skema for øgning af dosis for Mirapexin
Ascending – Dose Schedule of MIRAPEXIN
Hvis en yderligere øgning af den daglige dosis er nødvendig, bør denne øges med 0, 54 mg base (0, 75 mg salt) ugentligt op til maksimal døgndosis på 3, 3 mg base (4, 5 mg salt).
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
4. 8).
However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Vedligeholdelsesdosis Den daglige dosis bør være mellem 0, 264 mg base (0, 375 mg salt) og 3, 3 mg base (4, 5 mg salt).
The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
I tre kliniske optrapningsforsøg sås en effekt allerede ved en daglig dosis på 1, 1 mg base (1, 5 mg salt).
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Ca.
Further dose adjustments should be done based on the clinical response and the occurrence of undesirable effects.
5% af patienterne i de kliniske forsøg blev behandlet med doser mindre end 1, 1 mg (1, 5 mg salt).
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
For patienter med fremskreden Parkinsons sygdom, og hvor en reduktion af levodopa- dosis er tilsigtet, kan doser højere end 1, 1 mg (1, 5 mg salt) i døgnet være nyttig.
In advanced Parkinson’ s disease, doses higher than 1.1 mg (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Det kan anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Mirapexin, afhængigt af den enkelte patients reaktioner.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with MIRAPEXIN, depending on reactions in individual patients.
Behandlingsophør Pludseligt ophør af dopamin- behandling kan føre til udvikling af neuroleptisk malignt syndrom.
Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
Derfor bør pramipexol- dosis reduceres med 0, 54 mg base (0, 75 mg salt) per dag, indtil den daglige dosis er reduceret til 0, 54 mg base (0, 75 mg salt).
Therefore, pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt).
4. 4).
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Nedsat nyrefunktion Eliminationen af pramipexol er afhængig af nyrefunktionen.
The elimination of pramipexole is dependent on renal function.
• Ved kreatininclearance over 50 ml/ min. er dosisreduktion ikke nødvendig.
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
• Ved kreatininclearance mellem 20 og 50 ml/ min. bør initialdosis af Mirapexin fordeles på 2 daglige doser begyndende med 0, 088 mg base (0, 125 mg salt) to gange dagligt svarende til 0, 176 mg base (0, 25 mg salt) per døgn.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of MIRAPEXIN should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/ 0.25 mg of salt daily).
• Ved kreatininclearance mindre end 20 ml/ min. bør initialdosis af Mirapexin gives som en enkeltdosis begyndende med 0, 088 mg base (0, 125 mg salt) per døgn.
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of MIRAPEXIN should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Dvs. hvis f. eks. kreatininclearance reduceres med 30%, så reduceres den daglige dosis tilsvarende med 30%.
If renal function declines during maintenance therapy, reduce MIRAPEXIN daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the MIRAPEXIN daily dose by 30%.
Den daglige dosis kan fordeles på 2 daglige doser, hvis kreatininclearance er mellem 20 og 50 ml/ min. og 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.
Nedsat leverfunktion Dosisreduktion er sandsynligvis ikke nødvendig for patienter med nedsat leverfunktion, da omkring 90% af det absorberede aktive stof udskilles via nyrerne.
90% of absorbed active substance is excreted through the kidneys.
3 Restless Legs Syndrome
Restless Legs Syndrome
Tabletterne kan både indtages sammen med mad og alene og indtages peroralt sammen med vand.
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Den anbefalede startdosis for Mirapexin er 0, 088 mg base (0, 125 mg salt), som tages 1 gang dagligt 2 - 3 timer før sengetid.
The recommended starting dose of MIRAPEXIN is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
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.
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).
Titreringstrin 1 gang daglig Aften dosis (mg af base) 1 0, 088 2 0, 18 3 0, 35 4 0, 54
Once Daily Evening Dose (mg of salt)
1 gang daglig Aften dosis (mg af salt) 0, 125 0, 25 0, 50 0, 75
1 2* 3* 4* * if needed
Behandlingens effekt hos RLS- patienten og den forsatte behandling bør evalueres efter 3 måneders brug, eftersom langtidsvirkningen af Mirapexin ikke er tilstrækkelig kendt.
As long-term efficacy of MIRAPEXIN in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
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.
Behandlingsophør Mirapexin kan ved behandling af Restless Legs Syndrome seponeres uden aftrapning, idet dosis ikke vil overstige 0, 54 mg base (0, 75 mg salt).
Treatment discontinuation Since daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) MIRAPEXIN can be discontinued without tapering off.
Rebound (forværring af symptomer efter pludselig ophør af behandling) kan ikke udelukkes.
Rebound (worsening of symptoms after abrupt discontinuation of treatment) can not be excluded.
Nedsat nyrefunktion Udskillelse af pramipexol er afhængig af nyrefunktionen.
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
Patienter med en kreatininclearance over 20 ml/ min behøver ingen reduktion i den daglige dosis.
Patients with a creatinine clearance above 20 ml/ min require no reduction in daily dose.
Brugen af Mirapexin har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion.
The use of MIRAPEXIN has not been studied in hemodialysis patients, or in patients with severe renal impairment.
Nedsat leverfunktion Hos patienter med leversvigt er dosisjustering ikke nødvendig, da ca.
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is not required, as approx.
Børn og unge Mirapexin bør ikke anvendes til børn og unge under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
Dosing in children and adolescents MIRAPEXIN is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
4. 2.
-4- When prescribing MIRAPEXIN in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Hallucinationer Hallucinationer er en kendt bivirkning ved behandling med dopaminagonister og levodopa.
Hallucinations Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
Dyskinesi Ved fremskreden Parkinsons sygdom kan dyskinesi forekomme i optitreringsfasen med Mirapexin, når det gives i kombination med levodopa.
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of MIRAPEXIN.
I disse tilfælde bør levodopa- dosis reduceres.
If they occur, the dose of levodopa should be decreased.
4 Pludselig opståede søvnanfald og somnolens Mirapexin er blevet forbundet med somnolens og episoder med pludselig opståede søvnanfald, især hos patienter med Parkinsons sygdom.
Sudden onset of sleep and somnolence MIRAPEXIN has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Tilfælde af pludselig opstået søvn under daglige aktiviteter, i nogle tilfælde uden nogen form for advarsel, har været rapporteret.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Patienter, som har oplevet somnolens og/ eller en episode med pludselig 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.
4. 8).
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see section 4.7 and section 4.8).
Manglende impulskontrol og tvangshandlinger Ludomani, forøget libido og hyperseksualitet er set hos patienter, som blev behandlet med dopaminagonister for Parkinsons sygdom herunder Mirapexin.
Impulse control disorders and compulsive behaviours Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including MIRAPEXIN.
Patienter og pårørende bør være opmærksomme på, at adfærdsmønsteret kan ændre sig (symptomer på manglende impulskontrol og tvangshandlinger såsom uhæmmet madindtagelse og tvangshandling, der fører til overdrevent indkøbsmønster).
Furthermore, patients and caregivers should be aware of the fact that other behavioural symptoms of impulse control disorders and compulsions such as binge eating and compulsive shopping can occur.
Dosisreduktion/ gradvis ophør bør overvejes.
Dose reduction/ tapered discontinuation should be considered.
Patienter med psykotiske lidelser Patienter, som lider af psykotiske lidelser, bør kun behandles med dopaminagonister, hvis de potentielle fordele opvejer risikoen.
Patients with psychotic disorders Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
4. 5).
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Oftalmologisk monitorering Der anbefales oftalmologisk undersøgelse med regelmæssige mellemrum eller hvis der opstår synsabnormaliteter.
Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Alvorlig kardiovaskulær sygdom Forsigtighed tilrådes i tilfælde af alvorlig kardiovaskulær sygdom.
Severe cardiovascular disease In case of severe cardiovascular disease, care should be taken.
4. 2).
Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).
Augmentation Litteraturen rapporterer, at behandling af Restless Legs Syndrome med dopaminerge lægemidler kan resultere i augmentation.
Augmentation Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Generelt har de kontrollerede kliniske forsøg med Mirapexin hos patienter med Restless Legs Syndrome ikke været af tilstrækkelig varighed til at vurdere forekomsten af augmentation.
The controlled trials of MIRAPEXIN in patients with Restless Legs Syndrome were generally not of sufficient duration to adequately capture augmentation phenomena.
Hyppigheden af augmentation efter længerevarende brug af Mirapexin og korrekt håndtering af disse tilfælde er derfor ikke evalueret.
The frequency of augmentation after longer use of MIRAPEXIN and the appropriate management of these events have not been evaluated in controlled clinical trials.
Plasmaproteinbinding Pramipexol er kun i ringe udstrækning bundet til plasmaproteiner (< 20%), og der er kun set beskeden biotransformation hos mennesker.
-5- Plasma protein binding Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Lægemidler, der hæmmer den aktive,
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.