FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients must not take Zurampic if they suffer from tumour lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or a rare hereditary disease called LeschNyhan syndrome, both of which raise uric acid levels in the blood.
Danish: Patienterne må ikke få Zurampic, hvis de har en komplikation som følge af hurtig nedbrydning af kræftceller under kræftbehandling (tumorlysesyndrom) eller den sjældne arvelige sygdom LeschNyhan syndrom, som begge forhøjer blodets indhold af urinsyre.
English: Zurampic is used in combination with a xanthine oxidase inhibitor such as allopurinol or febuxostat.
Danish: Zurampic anvendes i kombination med en xanthinoxidasehæmmer såsom allopurinol eller febuxostat.
English: The active substance in Zurampic, lesinurad, helps to remove uric acid from the body.
Danish: Det aktive stof i Zurampic, lesinurad, medvirker til at udskille urinsyre fra kroppen.
English: Gout results from a build-up of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.
Danish: Podagra skyldes urinsyrekrystaller, der dannes i og omkring leddene, navnlig i tæerne, og bevirker smerter og hævelse.
English: Xanthine oxidase inhibitors reduce the production of uric acid in the body.
Danish: Xanthinoxidasehæmmere nedsætter produktionen af urinsyre i kroppen.
English: The medicine can only be obtained with a prescription.
Danish: Lægemidlet Zurampic udleveres kun efter recept.
English: Zurampic is a medicine used in adults with gout to reduce high levels of uric acid in the blood.
Danish: Zurampic er et lægemiddel, der anvendes hos voksne med podagra til at nedsætte et for højt indhold af urinsyre i blodet.
English: For the full list of all side effects reported with Zurampic, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zurampic fremgår af indlægssedlen.
English: For practical information about using Zurampic, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zurampic, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Zurampic used?
Danish: Hvordan anvendes Zurampic?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zurampic on 18 February 2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zurampic den <dato for udstedelse af markedsføringstilladelse>.
English: What benefits of Zurampic have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zurampic?
English: Combined with a xanthine oxidase inhibitor, Zurampic reduced blood levels of uric acid in patients with gout whose high uric acid levels were not sufficiently controlled by a xanthine oxidase inhibitor.
Danish: I kombination med en xanthinoxidasehæmmer nedsatte Zurampic blodets urinsyreindhold hos patienter med podagra, hos hvem et for højt urinsyreindhold ikke var kontrolleret tilfredsstillende alene med en xanthinoxidasehæmmer.
English: The main measure of effectiveness was the number of patients whose blood level of uric acid dropped below 50 mg/litre after 6 months of treatment.
Danish: Virkningen blev hovedsagelig målt på det antal patienter, hos hvem blodets indhold af urinsyre kom under 50 mg/l efter 6 måneders behandling.
English: The main measure of effectiveness was the number of patients whose blood level of uric acid dropped below 60 mg/litre after 6 months of treatment.
Danish: Virkningen blev hovedsagelig målt på det antal patienter, hos hvem blodkoncentrationen af urinsyre faldt til under 60 mg/l efter 6 måneders behandling.
English: How does Zurampic work?
Danish: Hvordan virker Zurampic?
English: It is used in combination with a xanthine oxidase inhibitor, another type of gout medicine, when the xanthine oxidase inhibitor on its own is not able to control uric acid levels sufficiently.
Danish: Det anvendes i kombination med en anden type medicin mod podagra, en xanthinoxidasehæmmer, når denne ikke alene kan kontrollere indholdet af urinsyre tilfredsstillende.
English: Thus, adding Zurampic to treatment with a xanthine oxidase inhibitor lowers uric acid levels further.
Danish: Når Zurampic anvendes som tillægsbehandling til en xanthinoxidasehæmmer, bliver koncentrationen af urinsyre nedsat endnu mere.
English: 2 (2 x 1) vials + 2 (2 x 1) syringes +2 (2 x 1) needles + 2 (2 x 1) vial adapters + 4 (2 x 2) alcohol pads (multipack)
Danish: 2 (2 x 1) hætteglas + 2 (2 x 1) injektionssprøjter +2 (2 x 1) kanyler + 2 (2x1) hætteglasadaptere + 4 (2 x 2) alkoholservietter (multipakning)
English: 1 pre-filled pen + 2 alcohol pads
Danish: 1 fyldt pen + 2 alkoholservietter
English: 1 vial + 1 syringe + 1 needle + 1 vial adapter + 2 alcohol pads
Danish: 1 hætteglas + 1 injektionssprøjter + 1 kanyler + 1 hætteglasadaptere
English: 1 pre-filled syringe + 2 alcohol pads
Danish: 6 fyldte injektionssprøjter alkoholservietter
English: The symptoms include:
Danish: Symptomerne er blandt andet:
English: In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Danish: I fortsatte, åbne undersøgelser over mere end 3 år var der ikke tegn på aftagende effekt.
English: However, your dose may have to be increased even further.
Danish: Det kan dog være nødvendigt at øge din dosis.
English: Each blister strip contains 10 tablets.
Danish: Hvert blisterkort indeholder 10 tablets.
English: - Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Danish: ændret eller øget interesse for sex og seksual adfærd, der vækker bekymring hos dig selv eller andre, f.eks. øget seksualdrift.
English: The usual maintenance dose is 1.1 mg per day.
Danish: Den sædvanlige vedligeholdelsesdosis er 1,1 mg pr. dag.
English: Tablet.
Danish: Tabletter.
English: Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Danish: Litteraturen rapporterer, at behandling af en anden indikation med dopaminerge lægemidler kan resultere i augmentation.
English: North Harrow, Middx HA1 4HF United Kingdom
Danish: North Harrow, Middx HA1 4HF Storbritannien
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: Inhibitors/competitors of active renal elimination pathway
Danish: Inhibitorer/kompetitiv hæmmere af den renale eliminationsvej
English: • Inability of keeping your body and neck straight and upright (axial dystonia).
Danish: • Manglende evne til at holde din krop og nakke lige og oprejst (aksial dystoni).
English: Very common: • Nausea (sickness)
Danish: Meget almindelige: • Kvalme
English: Patients should be regularly monitored for the development of impulse control disorders.
Danish: Patienter skal monitoreres regelmæssigt for udvikling af impulskontrolforstyrrelser.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apotek til råds, før du tager nogen form for medicin.
English: Therefore, do not take Pramipexole Accord if you are pregnant unless your doctor tells you to do so.
Danish: Derfor bør du ikke tage Pramipexole Accord, hvis du er gravid, medmindre din læge anbefaler dig at gøre det.
English: In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Danish: Hos mennesket er proteinbindingen af pramipexol meget lav (< 20%) og distributionsvolumet stort (400 l).
English: Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect.
Danish: Forudsat at patienten ikke får uacceptable bivirkninger, skal dosis titreres indtil den maksimale terapeutiske effekt.
English: For oral use
Danish: Til oral anvendelse.
English: Nausea and fatigue were more often reported in female patients treated with Pramipexole Accord (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 Pramipexole Accord (henholdsvis 20,8% og 10,5%) sammenlignet med mandlige patienter (henholdsvis 6,7% og 7,3%).
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Accord Healthcare S.L.U.
Danish: Indehaveren af markedsføringstilladelsen og fremstiller Indehaveren af markedsføringstilladelsen Accord Healthcare S.L.U.
English: HA1 4HF, Middlesex, United Kingdom
Danish: HA1 4HF, Middlesex,
English: Approximately 90% of 14C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Danish: Ca. 90% af en 14C-mærket dosis udskilles via nyrerne og mindre end 2% via fæces.
English: Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Danish: Dosisreduktion/gradvis seponering bør overvejes, hvis der udvikles sådanne symptomer.
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Danish: • Manglende evne til at modstå impulser, trangen eller fristelsen til at udføre aktiviteter, der kan skade dig selv eller andre.
English: Date of latest renewal: 15th July 2016
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 30. september 2011 Dato for seneste fornyelse: 15. jul 2016
English: METHOD AND ROUTE(S) OF ADMINISTRATION: Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: 1 This side effect has been observed in post-marketing experience.
Danish: 1 Bivirkninger observeret efter markedsføring.
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 30 tabletter
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: Virkningen af pramipexol (0,0625-0,5 mg/dag) hos pædiatriske patienter mellem 6-17 år med Tourettes sygdom blev evalueret i et 6-ugers, dobbeltblind, randomiseret, placebokontrolleret fleksibelt dosis-studie.
English: In early and advanced Parkinson's disease, efficacy of pramipexole in controlled clinical trials was maintained for approximately six months.
Danish: Ved tidlig og fremskreden Parkinsons sygdom blev effekten af pramipexol i de kontrollerede kliniske undersøgelser bevaret i ca. 6 måneder.
English: Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Danish: Cimetidin reducerer den renale clearance af pramipexol med ca. 34%, antagelig ved en hæmning af det kationiske sekretionstransportsystem i de renale tubuli.
English: • if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for pramipexol eller et af de øvrige indholdsstoffer (angivet i punkt
English: Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Fortæl det til din læge, hvis du eller din familie/plejer bemærker, at du udvikler trang eller stærk lyst til at gøre ting, som du normalt ikke gør, og at du ikke kan modstå impulsen, trangen eller fristelsen til at udføre visse aktiviteter, der kan skade dig selv eller andre.
English: Evaluation of these side effects is based on the following frequencies: Very common may affect more than 1 in 10 people
Danish: Bivirkningerne kan forekomme med en given hyppighed, som defineres på følgende måde: Meget almindelig Kan forekomme hos flere end 1 ud af 10 patienter
English: Pramipexole Accord should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Danish: Pramipexole Accord bør ikke bruges under graviditet, medmindre det er strengt nødvendigt, og hvis fordelene opvejer den potentielle risiko for fostret.
English: The tablet can be divided into two equal doses.
Danish: Tabletterne kan deles i to lige store dele.
English: In a controlled double blind clinical trial of 2 year duration, initial treatment with pramipexole significantly delayed the onset of motor complications, and reduced their occurrence compared to initial treatment with levodopa.
Danish: I en kontrolleret dobbeltblind klinisk undersøgelse af 2 års varighed, forsinkede initial behandling med pramipexol signifikant fremkomsten af motoriske komplikationer, og reducerede deres forekomst sammenlignet med initial behandling med levodopa.
English: The other ingredients are mannitol, cellulose microcrystalline, maize starch, silica colloidal anhydrous, povidone K 30 and magnesium stearate.
Danish: Øvrige indholdsstoffer: Mannitol, mikrokrystallinsk cellulose, majsstivelse, vandfri kolloid silica, povidon K 30 og magnesiumstearat.
English: Pack-sizes of 30 or 100 tablets
Danish: Pakninger med 30 eller 100 tabletter
English: If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day.
Danish: Om nødvendigt kan din læge øge din dosis op til 3,3 mg pramipexol pr. dag.
English: Pramipexole Accord tablets are packed in alu-alu blisters.
Danish: Pramipexole Accord tabletter er pakket i alu-alu blisterkort.
English: With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Danish: Med 95% sandsynlighed, er frekvenskategorien ikke højere end ”ikke almindelig” og kan være lavere.
English: Lowest maintenance dose
Danish: Laveste vedligeholdelsesdosis Højeste vedligeholdelsesdosis
English: Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Pramipexole Accord treatment.
Danish: Fortæl din læge, hvis du oplever symptomer såsom depression, apati, angst, træthed, svedtendens eller smerter, efter at du er stoppett med eller har nedsat dosis i din Pramipexole Accord-behandling.
English: All the strengths of Pramipexole Accord tablets are available in alu-alu blisters of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
Danish: Alle Pramipexole Accord-tabletstyrker fås i aluminium/aluminium blisterkort med 10 tabletter pr. kort i kartoner med 3 eller 10 blisterkort (30 eller 100 tabletter).
English: Clinical efficacy and safety in Tourette Disorder
Danish: Klinisk virkning og sikkerhed ved Tourettes sygdom
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 impulskontrolforstyrrelser og kan omfatte adfærd såsom spilleafhængighed, overdreven spisning eller overdrevent pengeforbrug, unormalt stor seksualdrift eller tiltagen i seksuelle tanker eller følelser.
English: Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
Danish: Toksicitetsstudier med gentagen dosering viser, at pramipexol udøver funktionelle virkninger, som hovedsagelig involverer CNS og det kvindelige reproduktionssystem, antagelig stammende fra en overdreven farmakodynamisk virkning af lægemidlet.
English: • Inappropriate antidiuretic hormone secretion*
Danish: • Uhensigtmæssig udskillelse af antidiuretisk hormon*
English: Very common:
Danish: Meget almindelige:
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 eller apoteket til råds, før du tager Pramipexole Accord.
English: You should tell your doctor if this occurs.
Danish: Fortæl det til din læge, hvis du oplever denne adfærd.
English: • Paranoia (e.g. excessive fear for one's own well-being)*
Danish: • Paranoia (f.eks. overdreven frygt for ens eget helbred)*
English: Pramipexole Accord is used to:
Danish: Pramipexole Accord bruges til:
English: Pramipexole may uncommonly be associated with libido disorders (increased or decreased).
Danish: Pramipexol kan i ikke almindelige tilfælde være forbundet med ændringer i libido (øget eller nedsat).
English: The effect on pregnancy and lactation has not been investigated in humans.
Danish: Effekten på graviditet og amning hos mennesker er ikke kendt.
English: Pramipexole is metabolised in man only to a small extent.
Danish: Pramipexol metaboliseres kun i ringe omfang hos mennesket.
English: Pramipexole Accord 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: Pramipexole Accord 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: Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Danish: Dyreforsøg har vist, at pramipexol hæmmer dopaminsyntese,frigørelse og -omsætning.
English: When Pramipexole Accord 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 Accord.
Danish: Når Pramipexole Accord gives i kombination med levodopa, anbefales det at reducere levodopadosis og at holde dosis af andre antiparkinson-lægemidler konstant, mens dosis af Pramipexole Accord øges.
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Accord, depending on reactions in individual patients (see section 4.5).
Danish: Det kan anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Pramipexole Accord, afhængigt af den enkelte patients reaktioner (se pkt.
English: Pramipexole Accord is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Danish: Pramipexole Accord anbefales ikke til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt hos denne population.
English: • unstable blood pressure
Danish: • ustabilt blodtryk
English: Pramipexole Accord has major influence on the ability to drive and use machines.
Danish: Pramipexole Accord har stor virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: The effect of Pramipexole Accord on the unborn child is not known.
Danish: Man ved ikke, hvilken virkning Pramipexole Accord kan have på det ufødte barn.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pramipexole Accord in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Pramipexole Accord hos alle undergrupper af den pædiatriske population ved Parkinsons sygdom (se pkt.
English: Your doctor will then discuss with you if you should continue to take Pramipexole Accord.
Danish: Din læge vil tale med dig, om du skal fortsætte med at tage Pramipexole Accord.
English: Rare: • Mania (agitation, feeling elated or over excited)
Danish: Sjælden: • Mani (føle sig oprørt, opstemt eller ophidset)
English: Manufacturer Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow
Danish: Sage house, 319 Pinner road,
English: • Delirium (decreased awareness, confusion, loss of reality)
Danish: • Delirium (nedsat bevidsthed, forvirring, manglende realitetsopfattelse)
English: Patients being treated with Pramipexole Accord 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 Pramipexole Accord, 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: In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Danish: I et karcinogenitets-studie udviklede hanrotter Leydig-cellehyperplasi og adenomer, pga. pramipexols prolaktinhæmmende effekt.
English: However, the potential influence of hepatic insufficiency on Pramipexole Accord pharmacokinetics has not been investigated.
Danish: Den potentielle indflydelse af nedsat leverfunktion på Pramipexole Accords farmakokinetik kendes ikke.
English: The leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest revideret <dato>
English: Any unused product or waste material should be disposed of in accordance with local requirement.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Store below 30°C.
Danish: Må ikke opbevares over 30 °C.
English: A lower maintenance dose of three Pramipexole Accord 0.088 mg tablets a day is also possible.
Danish: En lavere vedligeholdelsesdosis bestående af tre Pramipexole Accord 0,088 mg tabletter pr. dag er også mulig.
English: Pathological gambling, increased libido, hypersexuality, , compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Pramipexole Accord.
Danish: Sygelig spilletrang, øget libido, hyperseksualitet, kompulsiv trang til at bruge penge eller købe ting, overdreven spisning og tvangsspisning kan forekomme hos patienter behandlet med dopaminagonister, inklusive Pramipexole Accord (se pkt.
English: • Sleeplessness (insomnia)
Danish: • Søvnløshed (insomi)
English: There is no relevant use of Pramipexole Accord in the paediatric population for the children of Parkinson's disease.
Danish: Det er ikke relevant at anvende Pramipexole Accord hos den pædiatriske population ved indikationen Parkinsons sygdom.