FrancophonIA/ELRC3.0 huggingface dataset:
English: The final results of the complementary drug utilization study using databases, which allows a dual approach to assessing the effectiveness of the risk minimisation measures imposed on thiocolchicoside containing medicinal products, are expected in 2019, and this new due date should be reflected in the conditions of the Marketing Authorisation.
Danish: De endelige resultater af den supplerende undersøgelse af lægemiddelanvendelse, hvor der gøres brug af databaser, så der opnås en tosidet tilgang ved vurdering af, hvor effektive de risikominimerende foranstaltninger for indeholdende thiocolchicosid lægemidler er, forventes at foreligge i 2019, hvilket bør afspejles i betingelserne for markedsføringstilladelse.
English: February 2018 CMDh meeting
Danish: CMDh-møde januar 2018
English: The MAH(s) should provide within the risk management plan submission, a protocol for results of the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Danish: Indehaveren (indehaverne) af markedsføringstilladelse indsender som en del af risikostyringsplanen en protokol til en resultaterne af undersøgelsen af lægemiddelanvendelse med henblik på bedre karakterisering af den typiske kliniske ordinationspraksis for disse lægemidler hos repræsentative grupper af ordinerende læger og vurdering af hovedgrundene til ordination.
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Danish: CMDh er nået frem til, at markedsføringstilladelsen/-tilladelserne omfattet af denne PASSundersøgelsesrapport bør ændres.
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance thiocolchicoside and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner vedrørende undersøgelsesresultaterne for lægemidler, der indeholder det aktive stof thiocolchicosid, og som er omfattet af den endelige PASSundersøgelsesrapport, er CMDh af den opfattelse, at benefit/risk-forholdet for disse lægemidler forbliver uændret, under forudsætning af at de foreslåede ændringer indføres i produktinformationen.
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance thiocolchicoside and concerned by the PASS final report , the scientific conclusions are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport vedrørende den endelige PASS-undersøgelsesrapport (pålagt ikke-interventionel sikkerhedsundersøgelse efter markedsføring) for lægemidler, der indeholder det aktive stof thiocolchicosid, og som er omfattet af den endelige PASS-undersøgelsesrapport, er CMDh nået frem til følgende videnskabelige konklusioner:
English: The following changes to the conditions of the marketing authorisation(s) of medicinal products containing the active substance thiocolchicoside concerned by the PASS final report are recommended:
Danish: Det anbefales at indføre nedenstående ændringer af betingelserne for markedsføringstilladelse(r) for lægemidler, der indeholder det aktive stof thiocolchicosid, og som er omfattet af den endelige PASSundersøgelsesrapport:
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance thiocolchicoside concerned by the noninterventional imposed PASS final report
Danish: Ændringer, der skal indføres i betingelserne for markedsføringstilladelse(r) for lægemidler, der indeholder det aktive stof thiocolchicosid, og som er omfattet af den endelige PASSundersøgelsesrapport (pålagt ikke-interventionel sikkerhedsundersøgelse efter markedsføring)
English: You should tell your doctor if this occurs.
Danish: Du bør fortælle det til din læge, hvis dette sker.
English: PC: {number} [product code]
Danish: PC: {nummer} [produktkode]
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]
Danish: NN: {nummer} [nationalt refusionsnummer eller andet nationalt nummer, der identificerer lægemidlet]
English: Once daily.
Danish: Én gang daglig.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 1998
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 23. februar 1998 Dato for seneste fornyelse: 23. februar 2008
English: Furthermore a reduction of the dose or termination of therapy may be considered.
Danish: En reduktion af dosis eller ophør med behandling kan overvejes.
English: Therefore, do not take MIRAPEXIN if you are pregnant unless your doctor tells you to do so.
Danish: Derfor bør du ikke tage MIRAPEXIN, hvis du er gravid, medmindre din læge anbefaler dig at gøre det.
English: - Uncontrollable excessive shopping or spending
Danish: - Ukontrollerbart overdrevent indkøbsmønster og forbrug.
English: EXPIRY DATE EXP {MM/YYYY}
Danish: UDLØBSDATO EXP {MM/ÅÅÅÅ}
English: Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Danish: Det er rapporteret i litteraturen, at behandling af restless legs syndrom med dopaminerge lægemidler kan resultere i augmentation.
English: - Altered or increased sexual interest and behaviour of significant concern to you or to others,
Danish: - Ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER
English: Very common: - Nausea (sickness)
Danish: Meget almindelig: • Kvalme
English: Efficacy was maintained in 87 of 103 patients switched to MIRAPEXIN prolonged-release tablets.
Danish: Virkningen blev bevaret hos 87 ud af 103 patienter, som skiftede til Mirapexin depottabletter.
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data)..
Danish: Bivirkningerne er opført efter systemorganklasse og hyppighed (antal patienter, der forventes, at opleve en bivirkning) ved brug af følgende kategorier: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Nausea and fatigue were more often reported in female patients treated with MIRAPEXIN (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Danish: Kvalme og træthed blev oftere rapporteret hos kvindelige patienter behandlet med Mirapexin (henholdsvis 20,8% og 10,5%) sammenlignet med mandlige patienter (henholdsvis 6,7% og 7,3%).
English: Table 2: Restless Legs Syndrome Body System Very common
Danish: Tabel 2: Restless legs syndrom Kropssystem Meget almindelig
English: MIRAPEXIN should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Danish: Mirapexin bør ikke anvendes under graviditeten, medmindre det er strengt nødvendigt, og hvis fordelene opvejer den potentielle risiko for fostret.
English: 100 tablets
Danish: 100 tabletter
English: Patients with kidney disease If you have severe kidney disease, MIRAPEXIN may not be a suitable treatment for you.
Danish: Patienter med nyresygdomme Hvis du har en alvorlig nyresygdom, er MIRAPEXIN måske ikke den egnede behandling for dig.
English: The use of MIRAPEXIN tablets should be considered.
Danish: Anvendelse af Mirapexin tabletter bør overvejes i stedet.
English: Although dystonia may be a symptom of Parkinson's disease, the symptoms in these patients have improved after reduction or withdrawal of pramipexole.
Danish: Selvom dystoni kan være et symptom på Parkinsons sygdom, er symptomerne hos disse patienter bedret efter reduktion eller seponering af pramipexol.
English: - Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)).
Danish: • Dystoni (manglende evne til at holde din krop og nakke lige og oprejst (aksial dystoni)).
English: 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 Clinical Global Impressions of Severity of Illness (CGI-S).
English: Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05.
Danish: Farmakoterapeutisk klassifikation: Anti-Parkinson lægemiddel, dopaminreceptoragonist, ATC-kode: N04BC05
English: It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Danish: Det anbefales at monitorere blodtrykket, særlig i starten af behandlingen, på grund af risikoen for postural hypotention i forbindelse med dopaminbehandling.
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: In the Phase III studies that established safety and efficacy of MIRAPEXIN prolonged-release tablets, patients were instructed to take study medication without regard to food intake.
Danish: I de fase-III-studier, hvor sikkerhed og virkning af Mirapexin depottabletter blev undersøgt, blev patienterne instrueret i at tage studiemedicinen uden hensyntagen til fødeindtagelse.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 6.4 Special precautions for storage Do not store above 30°C.
Danish: 6.4 Særlige opbevaringsforhold Må ikke opbevares ved temperaturer over 30 °C.
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 tabletter
English: Parkinson's disease The daily dose is to be taken divided into 3 equal doses.
Danish: Parkinsons sygdom Døgndosis bør indtages ligeligt fordelt på 3 daglige doser.
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: To af studierne blev udført hos patienter med tidlig Parkinsons sygdom, og det 3. studie blev udført hos patienter med fremskreden Parkinsons sygdom.
English: Take your MIRAPEXIN (immediate release) tablets as normal the day before you switch.
Danish: Tag dine almindelige MIRAPEXIN tabletter som normalt dagen før, du skifter.
English: The use of MIRAPEXIN has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Danish: Brugen af Mirapexin har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tagerMIRAPEXIN.
English: Your doctor will then discuss with you if you should continue to take MIRAPEXIN.
Danish: Din læge vil tale med dig, om du skal fortsætte med at tage MIRAPEXIN.
English: Warnings and precautions Talk to your doctor before taking MIRAPEXIN.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager MIRAPEXIN.
English: The effect of MIRAPEXIN on the unborn child is not known.
Danish: Det er ukendt, hvilken virkning MIRAPEXIN kan have på det ufødte barn.
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: Pramipexole is completely absorbed following oral administration.
Danish: Pramipexol absorberes fuldstændigt efter oral administration.
English: MIRAPEXIN 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: Mirapexin 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: Each blister strip contains 10 tablets.
Danish: Hvert blisterkort indeholder 10 tabletter.
English: Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 59320 Ennigerloh Germany
Danish: Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 59320 Ennigerloh Tyskland
English: Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your MIRAPEXIN 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 MIRAPEXIN-behandling.
English: Rare: - Mania (agitation, feeling elated or over-excited)
Danish: Sjælden: • Mani (føle sig oprørt, opstemt eller ophidset)
English: Do not take MIRAPEXIN: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke MIRAPEXIN: - hvis du er allergisk over for pramipexol eller et af de øvrige indholdsstoffer i MIRAPEXIN
English: The other ingredients are hypromellose 2208, maize starch, carbomer 941, colloidal anhydrous silica, magnesium stearate.
Danish: Øvrige indholdsstoffer: hypromellose 2208, majsstivelse, carbomer 941, kolloid vandfri silica, magnesiumstearat.
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 opstår synsabnormaliteter.
English: Tablets can be divided into equal halves.
Danish: Tabletterne kan deles i to lige store dele.
English: MIRAPEXIN prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
Danish: Mirapexin depottabletter var non-inferior i forhold til pramipexoltabletter vurderet ud fra UPDRS del II+III score ved uge 33.
English: MIRAPEXIN prolonged-release tablets is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
Danish: MIRAPEXIN depottabletter er specialfremstillede tabletter, hvor det aktive stof langsomt frigives efter indtagelse af tabletten.
English: In a placebo-controlled polysomnography study over 3 weeks MIRAPEXIN significantly reduced the number of periodic limb movements during time in bed.
Danish: I et placebo-kontrolleret polysomnografi-studie over 3 uger reducerede Mirapexin signifikant antallet af periodiske benbevægelser, mens forsøgspersonerne var sengeliggende.
English: The treatment of patients with a creatinine clearance below 30 ml/min with MIRAPEXIN 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 Mirapexin depottabletter, da der ikke findes data for denne patientpopulation.
English: Do not chew, divide or crush the prolongedrelease tablets.
Danish: Du må ikke tygge, dele eller knuse depottabletten.
English: In the absence of human data, MIRAPEXIN should not be used during breast-feeding.
Danish: På grund af mangel på humane data må Mirapexin ikke anvendes under amning.
English: Ascending dose schedule of MIRAPEXIN Week
Danish: Skema for dosisøgning af Mirapexin Uge
English: Some patients have reported the occurrence of remnants in faeces which may resemble intact MIRAPEXIN prolonged-release tablets.
Danish: Nogle patienter har rapporteret om rester i afføringen, der kan ligne intakte Mirapexin depottabletter.
English: Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with MIRAPEXIN.
Danish: Det bør overvejes at nedsætte pramipexoldosis i tilfælde, hvor disse lægemidler administreres samtidigt med Mirapexin.
English: The active substance is pramipexole.
Danish: Aktivt stof: pramipexol.
English: The safety and efficacy of MIRAPEXIN 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 Mirapexin depottabletter ved behandling af Parkinsons sygdom blev undersøgt i et multinationalt klinisk udviklingsprogram bestående af 3 randomiserede, kontrollerede studier.
English: Then take your MIRAPEXIN prolonged-release tablets next morning and do not take any more MIRAPEXIN (immediate release) tablets.
Danish: Tag MIRAPEXIN depottabletter den næste morgen, og tag så ikke flere almindelige MIRAPEXIN tabletter.
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 MIRAPEXIN 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 Mirapexin depottabletter.
English: However, the potential influence of hepatic insufficiency on MIRAPEXIN pharmacokinetics has not been investigated.
Danish: Den potentielle indflydelse af nedsat leverfunktion på Mirapexins farmakokinetik kendes ikke.
English: MIRAPEXIN prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Danish: Mirapexin depottabletter er én-gang-daglig oral formulering af pramipexol.
English: The maximum plasma concentrations occur at about 6 hours after administration of MIRAPEXIN prolonged-release tablets once daily.
Danish: Den maksimale plasmakoncentration opnås ca. 6 timer efter administration af Mirapexin depottabetter givet en gang daglig.
English: MIRAPEXIN 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: Mirapexin 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: The European Medicines Agency has deferred the obligation to submit the results of studies with MIRAPEXIN 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 Mirapexin i en eller flere undergrupper af den pædiatriske population med restless legs syndrom (se pkt.
English: Only one patient switched to MIRAPEXIN prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Danish: Kun en patient, som skiftede til Mirapexin depottabletter, fik en lægemiddelrelateret bivirkning, der medførte seponering.
English: The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.
Danish: Øvrige indholdsstoffer: mannitol, majsstivelse, kolloid vandfri silica, povidon K 25 og magnesiumstearat.
English: When MIRAPEXIN 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 MIRAPEXIN.
Danish: Når Mirapexin gives i kombination med levodopa, anbefales det at reducere levodopa-dosis og at holde dosis af andre antiparkinson-lægemidler konstant, mens dosis af Mirapexin øges.
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 forover (denne tilstand kaldes antecollis), at din lænd bøjer forover (denne tilstand kaldes camptocormia), eller at din ryg falder til siden (denne tilstand kaldes pleurothotonus eller Pisa-syndrom)
English: OPA/aluminium/PVC-aluminium blisters.
Danish: Emballagetype og pakningsstørrelser OPA/aluminium/PVC-aluminium blister.
English: If you forget to take a dose of MIRAPEXIN, 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 MIRAPEXIN 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: It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Danish: MIRAPEXIN kan tages alene eller i kombination med levodopa (medicin til behandling af Parkinsons sygdom)
English: Patients being treated with MIRAPEXIN 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 Mirapexin, og som har oplevet døsighed, somnolens og/eller episoder med pludseligt opstået søvn, bør informeres om, at de skal afstå fra at køre bil eller deltage i aktiviteter, hvor nedsat årvågenhed kan udsætte dem eller andre for alvorlig fare eller død (f.eks. betjening af maskiner), indtil sådanne tilbagevendende episoder, døsighed og/eller somnolens er ophørt (se også pkt.
English: - Sleepiness and episodes of suddenly falling asleep
Danish: • Udtalt træthed om dagen og episoder med pludselig indsættende søvn
English: Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Danish: Pramipexol lindrer det motoriske underskud forbundet med Parkinsons sygdom ved stimulation af dopaminreceptorer i corpus striatum.
English: MIRAPEXIN can have a major influence on the ability to drive and use machines.
Danish: Mirapexin kan påvirke evnen til at føre motorkøretøj og betjene maskiner i væsentlig grad.