FrancophonIA/ELRC3.0 huggingface dataset:
English: Starting treatment with Zinbryta is not recommended for patients with autoimmune diseases other than multiple sclerosis and caution should be used when giving Zinbryta together with medicines that can damage the liver.
Danish: Indledning af behandling med Zinbryta anbefales ikke til patienter med andre autoimmune sygdomme end multipel sklerose, og forsigtighed bør udvises, når der gives Zinbryta sammen med lægemidler, der kan skade leveren.
English: • Treatment initiation is not recommended in patients with concurrent autoimmune conditions other than multiple sclerosis and in patients with serum transaminases (ALT or AST) that are at least twice the upper limit of normal (≥ 2 times the ULN).
Danish: • Indledning af behandling frarådes hos patienter med andre samtidige autoimmune lidelser end multipel sklerose og hos patienter med serum transaminaser (ALT eller AST), som er mindst det dobbelte af den øvre grænse for normal (≥ 2 gange ULN).
English: • As a precaution and while the review is ongoing, Zinbryta's use has been restricted to adult patients with highly active relapsing disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or with rapidly evolving severe relapsing multiple sclerosis who are unsuitable for treatment with other DMTs.
Danish: • Som en sikkerhedsforanstaltning, og mens undersøgelsen pågår, er brugen af Zinbryta blevet begrænset til voksne patienter med meget aktiv recidiverende sygdom trods en fuldstændig og tilstrækkelig behandling med mindst én sygdomsmodificerende behandling (DMT) eller med hurtigt progredierende svær recidiverende dissemineret sklerose, som er uegnet til behandling med andre DMT'er.
English: The review of Zinbryta started after the death from liver injury (fulminant liver failure) of a patient involved in an ongoing observational study, as well as four cases of serious liver injury.
Danish: Eftersynet af Zinbryta startede, efter at en patient, der indgik i et igangværende observationsstudie, døde af leverskader (fulminant leversvigt) samt 4 tilfælde af alvorlige leverskader.
English: The European Medicines Agency (EMA) has provisionally restricted the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foreløbig indskrænket brugen af multipel sklerose medicinen Zinbryta (daclizumab) til patienter med meget aktiv recidiverende sygdom, der ikke har reageret på visse andre behandlingsformer, og patienter med hurtigt progredierende recidiverende, sygdom der ikke kan behandles med anden medicin.
English: Zinbryta is available as a solution for injection in pre-filled pens and syringes.
Danish: Zinbryta fås som injektionsvæske, opløsning, i fyldte penne og sprøjter.
English: • The use of Zinbryta has been restricted to patients with highly active relapsing disease that has failed to respond to other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.
Danish: • Brugen af Zinbryta er bleved begrænset til patienter med meget aktiv recidiverende sygdom, der ikke har reageret på visse andre behandlingsformer, og patienter med hurtigt progredierende recidiverende, sygdom der ikke kan behandles med anden medicin.
English: • The ongoing safety review was triggered following the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.
Danish: • De igangværende sikkerhedsgennemgang blev udløst, efter at en patient, der indgik i et igangværende observationsstudie, døde af leverskader (fulminant leversvigt) samt 4 tilfælde af alvorlige leverskader.
English: Oprymea received a marketing authorisation valid throughout the EU on 12 September 2008.
Danish: Oprymea fik en markedsføringstilladelse med gyldighed i hele EU den 12. september 2008.
English: Further information on Oprymea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere oplysninger om Oprymea findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Oprymea
Danish: Andre oplysninger om Oprymea
English: The prolonged-release tablets must not be chewed, divided or crushed, and should be taken around the same time every day.
Danish: Depottabletterne må ikke tygges, deles eller knuses og bør tages på ca. samme tid hver dag.
English: Oprymea must be given less frequently in patients who have problems with their kidneys.
Danish: Oprymea skal gives mindre hyppigt til patienter, som har problemer med nyrerne.
English: Oprymea is a ‘generic medicine'.
Danish: Oprymea er et "generisk lægemiddel".
English: Oprymea is a medicine used to treat the symptoms of the following diseases:
Danish: Oprymea er et lægemiddel, der anvendes til behandling af symptomerne på følgende sygdomme:
English: If treatment needs to be stopped for any reason, the dose should be decreased gradually.
Danish: Hvis der opstår behov for at indstille behandlingen, bør dosis nedtrappes gradvist.
English: Oprymea tablets should be swallowed with water.
Danish: Oprymea-tabletterne bør synkes med vand.
English: Oprymea can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Danish: Oprymea kan enten anvendes alene eller i kombination med levodopa (et andet lægemiddel til behandling af Parkinsons sygdom) på et hvilket som helst stadium af sygdommen, herunder de senere stadier, når levodopa begynder at blive mindre effektivt
English: As for all medicines, data on the use of Oprymea are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Oprymea løbende overvåget.
English: For more information about using Oprymea, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Oprymea, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: It is available as immediate-release tablets (0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg and 1.1 mg) and prolonged-release tablets (0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg).
Danish: Det fås som tabletter med øjeblikkelig frigivelse (0,088 mg, 0,18 mg, 0,35 mg, 0,7 mg og 1,1 mg) og som depottabletter (0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg og 3,15 mg).
English: What measures are being taken to ensure the safe and effective use of Oprymea?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Oprymea?
English: An overview of Oprymea and why it is authorised in the EU
Danish: En oversigt over Oprymea, og hvorfor det er godkendt i EU
English: Side effects reported with Oprymea are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Oprymea vurderes omhyggeligt, og der tages i givet fald nødvendige forholdsregler for at beskytte patienterne.
English: What are the benefits and risks of Oprymea?
Danish: Hvilke fordele og risici er der forbundet med Oprymea?
English: As for every medicine, the company provided studies on the quality of Oprymea.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Oprymea.
English: Oprymea (pramipexole)
Danish: Oprymea (pramipexol)
English: Oprymea is used when a specific cause for the disorder cannot be identified.
Danish: Oprymea anvendes, når det ikke er muligt at fastslå en årsag til sygdommen.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Oprymea has been shown to have comparable quality and to be bioequivalent to Sifrol.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Oprymea er af sammenlignelig kvalitet og er bioækvivalent med Sifrol.
English: • moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Danish: • moderat til svær grad af uro i benene (Restless Legs Syndrome), som er en lidelse, hvor patienten har en uimodståelig trang til at bevæge lemmerne for at standse ubehagelige, smertefulde eller underlige fornemmelser i kroppen, sædvanligvis om natten.
English: This means that Oprymea contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Sifrol (also known as Mirapexin).
Danish: Det betyder, at Oprymea indeholder det samme aktive stof og virker på samme måde som et ”referencelægemiddel”, som allerede er godkendt i EU, og som hedder Sifrol (bliver også kaldt for Mirapexin).
English: Immediate-release tablets release the active substance into the body immediately, and prolonged-release tablets release it slowly over a few hours.
Danish: Ved tabletter med øjeblikkelig frigivelse frigives det aktive stof straks, og ved depottabletter frigives det langsomt i løbet af nogle timer.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Sifrol, and do not need to be repeated for Oprymea.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Sifrol, og det er ikke nødvendigt at gentage disse med Oprymea.
English: • Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Danish: • Parkinsons sygdom, som er en fremadskridende hjernesygdom, der medfører rysten, langsomme bevægelser og muskelstivhed.
English: What is Oprymea and what is it used for?
Danish: Hvad er Oprymea, og hvad anvendes det til?
English: The recommended starting dose is one 0.088 mg tablet, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of three 0.18 mg tablets.
Danish: Den anbefalede startdosis er en 0,088 mg-tablet, men om nødvendigt kan dosen sættes op hver fjerde til hver syvende dag for at dæmpe symptomerne yderligere indtil en maksimal dosis på tre 0,18 mg-tabletter.
English: The patient's response and the need for further treatment should be evaluated after three months.
Danish: Efter tre måneder vurderes behandlingens virkning og behovet for fortsat behandling.
English: Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.
Danish: Pramipexol stimulerer hjernen på samme måde som dopamin, så patienten kan styre sine bevægelser og har færre tegn og symptomer på Parkinsons sygdom som f.eks. rysten, stivhed og langsomme bevægelser.
English: Because Oprymea is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Oprymea er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For restless-legs syndrome, Oprymea immediate-release tablets should be taken once a day, two to three hours before going to bed.
Danish: Ved Restless Legs Syndrome bør Oprymea-tabletter med øjeblikkelig frigivelse tages én gang dagligt to til tre timer før sengetid.
English: Why is Oprymea authorised in the EU?
Danish: Hvorfor blev Oprymea godkendt i EU?
English: Oprymea can only be obtained with a prescription.
Danish: Oprymea udleveres kun efter recept.
English: Oprymea contains the active substance pramipexole.
Danish: Oprymea indeholder det aktive stof pramipexol.
English: The active substance in Oprymea, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Danish: Det aktive stof i Oprymea, pramipexol, er en dopaminagonist, som efterligner virkningen af dopamin.
English: Therefore, the Agency's view was that, as for Sifrol, the benefit of Oprymea outweighs the identified risk and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Oprymea opvejer de identificerede risici som for Sifrol, og anbefalede, at det godkendes til anvendelse i EU.
English: For Parkinson's disease, the starting dose is either one 0.088 mg immediate-release tablet three times a day or one 0.26 mg prolonged-release tablet once a day.
Danish: Ved Parkinsons sygdom er startdosis enten en 0,088-mg-tablet med øjeblikkelig frigivelse tre gange dagligt eller en 0,26-mg-depottablet én gang dagligt.
English: The maximum daily dose for the immediate-release tablets is 1.1 mg three times a day and in case of the prolonged release tablets is 3.15 mg once a day.
Danish: Den maksimale daglige dosis er en 1,1 mg-tablet med øjeblikkelig frigivelse tre gange dagligt eller en 3,15 mg-depottablet én gang om dagen.
English: The prolonged-release tablets are not suitable for restless-legs syndrome.
Danish: Depottabletterne er ikke egnede til behandling af uro i benene.
English: How has Oprymea been studied?
Danish: Hvordan blev Oprymea undersøgt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oprymea have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Oprymea.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which can be corrected by pramipexole.
Danish: Syndromet menes at skyldes problemer med den måde, dopamin virker på i hjernen.
English: How is Oprymea used?
Danish: Hvordan anvendes Oprymea?
English: How does Oprymea work?
Danish: Hvordan virker Oprymea?
English: The way pramipexole works in restless-legs syndrome is not fully understood.
Danish: Det vides endnu ikke med nøjagtighed, hvordan pramipexol virker mod uro i benene.
English: • At the request of the EMEA
Danish: • Efter anmodning fra EMEA.
English: - are a young adult.
Danish: - er en yngre person.
English: In addition, an updated RMP should be submitted
Danish: Yderligere skal en opdateret RMP indsendes:
English: Specific in vivo drug interaction studies have not been performed.
Danish: Der er ikke udført specifikke in vivo interaktionsstudier.
English: Frequency estimate: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥ 1/10,000 and <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Skønnet hyppighed: Meget almindelig (≥1/10, almindelig (≥1/100 og <1/10), ikke almindelige (≥1/1000 og <1/100), sjælden (≥1/10.000 og <1/1000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Talk to your doctor if you have high blood pressure.
Danish: Fortæl det til din læge, hvis du har forhøjet blodtryk.
English: These medicines might increase the risk of bleeding.
Danish: Denne form for medicin kan forøge risikoen for blødninger.
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself.
Danish: Du vil mere sandsynligt tænke på dette, hvis du: - tidligere har haft tanker om at begå selvmord eller om at skade dig selv.
English: The underlying mechanism and the clinical relevance are unknown.
Danish: Den underliggendende mekanisme og den kliniske relevans er uvis.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: Ifølge CHMP Guideline for Risk Management Systems for lægemidler til human brug, skal den opdaterede RMP indsendes samtidig med den næste periodiske sikkerhedsopdateringsrapport (PSUR).
English: Therefore,in patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
Danish: Hos patienter med kendt hypertension og/eller anden hjertelidelse anbefales det derfor, at blodtrykket monitoreres, særligt i løbet af den første måned af behandlingen.
English: Oral anticoagulants: medicines which thin the blood.
Danish: Orale antikoagulantia: Medicin, der fortynder blodet.
English: Talk to your doctor before you take the medicine if you:
Danish: Kontakt din læge før du tager medicinen, hvis du:
English: Tell your doctor if you
Danish: Fortæl det til din læge, hvis du
English: De la Industria, 30,28108 Alcobendas, Madrid, Spain.
Danish: De la Industria 30, 28108 Alcobendas, Madrid, Spanien.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Danish: Der mangler data på langtidssikkerhed hos børn og unge hvad angår vækst, modning, kognitiv- og adfærdsudvikling.
English: SPECIAL STORAGE CONDITIONS Store in the original package.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning.
English: • poor sleep quality
Danish: • dårlig søvnkvalitet
English: There are no data on the use of duloxetine in pregnant women.
Danish: Der er ingen data for brug af duloxetin hos gravide kvinder.
English: Duloxetine is approximately 96% bound to human plasma proteins.
Danish: Ca. 96 % af duloxetin er bundet til humane plasmaproteiner.
English: Use with antidepressants
Danish: Samtidig brug af antidepressiva
English: The MAH must ensure that the system of pharmacovigilance, as described in Edition 5.2 dated April 2009 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilancesystemet version 5.2 dateret april 2009 og præsenteret i Modul 1.8.1 af markedsføringstilladelsen er på plads og fungerer før og mens, lægemidlet er på markedet.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • Inden for 60 dage efter at en vigtig milepæl er nået i forbindelse med (pharmacovigilance eller risikominimering).
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucroseisomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige lidelser som fructoseintolerans, glucose-galactose-malabsorption eller invertaseisomaltase-insufficiens bør ikke tage denne medicin.
English: There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
Danish: Der kan forekomme følelsesløshed i det angrebne område, eller påvirkninger såsom berøring, varme, kulde eller tryk kan fremkalde smerte.
English: • tinnitus (perception of sound in the ear when there is no external sound)
Danish: • øresusen (tinnitus: hører lyde i øret, selvom der ingen lyde er ude)
English: The therapeutic benefit should be reassessed regularly (at least every three months) (see Section 5.1).
Danish: Den terapeutiske effekt bør vurderes med jævne mellemrum (mindst hver tredje måned) (se pkt.
English: Age: pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Danish: Alder: Der er fundet farmakokinetiske forskelle mellem yngre og ældre kvinder (≥ 65 år) (AUCværdien forøges med ca. 25 %, og halveringstiden er ca. 25 % længere hos ældre) men omfanget af disse forandringer er ikke tilstrækkelige til at retfærdiggøre dosisjusteringer.
English: Treatment of diabetic peripheral neuropathic pain in adults.
Danish: Behandling af perifere diabetiske neuropatiske smerter hos voksne.
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i original yderpakning for at beskytte mod fugt.
English: Patients meeting diagnostic criteria for major depressive disorder were excluded from these trials.
Danish: Patienter, som levede op til diagnose kriterierne for moderat til svær depression, blev ekskluderet fra disse forsøg.
English: • an increased level of sugar in the blood
Danish: • forhøjet blodsukker
English: • syndrome of inadequate secretion of anti-diuretic hormone (SIADH)
Danish: • utilstrækkelig sekretion af anti-diuretisk hormon (SIADH).
English: Polyvinylchloride (PVC), Polyethylene (PE), and Polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminum foil.
Danish: Polyvinylchlorid (PVC), polyethylen (PE) og polychlorotrifluoroethylen (PCTFE)-blister forseglet med aluminiumfolie.
English: Gender: pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximatively 50% lower in females).
Danish: Køn: Der er fundet farmakokinetiske forskelle mellem mænd og kvinder (den tilsyneladende plasmaclearance er tilnærmelsesvis 50 % lavere hos kvinder).
English: • feeling disorientated, feeling sleepy, lack of motivation
Danish: • hølelse af desorientering, føle dig søvnig, mangel på motivation
English: Hypertension Hypertensive crisis
Danish: Hypertension Hypertensive kriser
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in Revision 0 of 24 April 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og yderligere pharmacovigilanceaktiviteter, der er specificeret i den plan for pharmacovigilance, som er godkendt i revision 0 af 24. april 2008 af den risk managementplan (RMP), som er præsenteret Modul 1.8.2 af markedsføringstilladelsen, og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: • sexual problems, including changes in ejaculation and abnormal orgasm
Danish: • seksuelle problemer, herunder ændringer i udløsning og orgasme
English: • hallucinations, suicidal thoughts, behaviour aggression and anger
Danish: • hallucinationer, selvmordstanker, opførsel med aggression og vrede
English: Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Danish: Hyponatriæmi kan skyldes et syndrom med uhensigtsmæssig sekretion af anti-diuretisk hormon (SIADH).
English: Blood cholesterol increased
Danish: Øget blodkolesterol
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetinetreated and placebo-treated patients.
Danish: Der blev ikke observeret nogen klinisk signifikante forskelle på QT-, PR-, QRS- eller QTcB-målinger mellem duloxetinbehandlede og placebobehandlede patienter.
English: Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Danish: Der skal udvises forsigtighed ved behandling af følgende patienter med øget risiko for hyponatriæmi: Ældre, cirrose eller dehydrerede patienter samt patienter i behandling med diuretika.
English: Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive.
Danish: På baggrund af in vitro forsøg betragtes duloxetins cirkulerende metabolitter som farmakologisk inaktive.
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed over for det aktive stof eller overfor et eller flere af hjælpestofferne.
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase) Hepatitis3
Danish: Forhøjede leverenzymer (ALAT, ASAT, alkalisk fosfatase) Hepatitis3