FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and Cuprior Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Danish: Brug af anden medicin sammen med Cuprior Fortæl lægen, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det.
English: The rat NOAEL was considered 50 mg/kg/day for females, a NOAEL was not established for males.
Danish: NOAEL-værdien for hunrotter blevet anset for at være 50 mg/kg/dag; der blev ikke bestemt en NOAEL-værdi for hanrotter.
English: Driving and using machines Cuprior is not expected to affect your ability to drive a car or use any tools or machines.
Danish: Trafik- og arbejdssikkerhed Cuprior forventes ikke at påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Taking into account that trientine has irritating properties, it was estimated that the observed chronic interstitial pneumonitis was explained by a cytotoxic effect of trientine upon accumulation into bronchiolar epithelial cells and alveolar pneumocytes.
Danish: På baggrund af de lokalirriterende egenskaber af trientin skønnedes den iagttagne kroniske interstitielle pneumonitis at kunne forklares ved en cytotoksisk virkning af trientin som følge af akkumulering i bronkiernes epitelceller og alveolære pneumocytter.
English: The association of trientine with another medicine that contains zinc is not recommended.
Danish: Det frarådes at kombinere trientin med et andet lægemiddel, der indeholder zink.
English: This medicine mainly works by attaching to copper in the body which then allows it to be removed in the urine instead, helping to lower copper levels.
Danish: Dette lægemiddel virker hovedsagelig ved at bindes til kroppens indhold af kobber, der derved i stedet kan udskilles gennem urinen, så indholdet af kobber mindskes.
English: The active substance is trientine.
Danish: Aktivt stof: trientin.
English: Close monitoring is required to optimise the dose or to adapt treatment if necessary (see section 4.4).
Danish: Der kræves tæt overvågning for at optimere dosis eller tilpasse behandlingen, hvis dette er nødvendigt (se pkt.
English: In rats administered oral trientines doses, up to 600 mg/kg/day for 26 weeks, histopathology revealed a dose-related incidence and severity of focal chronic interstitial pneumonitis accompanied by fibrosis of the alveolar wall.
Danish: Ved histopatologisk undersøgelse af rotter, der fik orale doser af trientin op til 600/kg/dag i 26 uger, sås dosisrelateret forekomst og sværhed af fokal kronisk interstitiel pneumonitis ledsaget af fibrose af alveolevæggene.
English: Tablet core: mannitol, colloidal anhydrous silica and glycerol dibehenate.
Danish: Tabletkerne indhold: mannitol, silica, kolloid, vandfri og glyceroldibehenat..
English: DELPHARM EVREUX 5 rue du Guesclin 27000 Evreux France
Danish: DELPHARM EVREUX 5 rue du Guesclin 27000 Evreux Frankrig
English: Marketing Authorisation Holder gmp-orphan SA
Danish: Indehaver af markedsføringstilladelsen gmp-orphan SA
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX12.
Danish: Farmakoterapeutisk klassifikation: Div. midler til fordøjelsesorganer og stofskifte, ATC-kode: A16AX12.
English: Kidney and body weights were reduced in males as was the incidence of renal cytoplasmic vacuolisation.
Danish: Nyre- og kropsvægt var nedsat hos handyr, hvilket ligeledes gjaldt forekomsten af vakuolisering i nyrernes cytoplasma.
English: Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.
Danish: Trientin kan desuden danne chelat med kobber i mave-tarmkanalen og derved hæmme absorptionen af kobber.
English: - inflammation of the gut which may lead to e.g. abdominal pain, recurring diarrhoea and blood in stools (colitis) - decrease in the number of red blood cells due to low iron level in your blood (iron deficiency anaemia) - urticaria (nettle rash or hives).
Danish: - Mavebesvær og -ubehag, herunder svære mavesmerter (duodenitis) - Inflammation af tarmen, som kan medføre fx mavesmerter, tilbagevendende diarré og blodig afføring (colitis) - Nedsat antal røde blodlegemer pga. lavt jernindhold i blodet (jernmangelanæmi) - Nældefeber (urticaria)
English: The film-coated tablet can be divided into equal doses.
Danish: Den filmovertrukne tablet kan deles i to lige store doser.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: If you forget to take Cuprior
Danish: Hvis du har glemt at tage Cuprior
English: If you stop taking Cuprior
Danish: Hvis du holder op med at tage Cuprior
English: Hematopoietic cell proliferation was seen in the spleen of males.
Danish: Der sås proliferation af hæmopoietiske celler i milten på handyr.
English: 50 mg/kg/day resulting in safety margins of about 4 in males and 17 in females, towards human therapeutic exposures.
Danish: NOAEL-værdien blev bestemt til 50 mg/kg/dag, svarende til en sikkerhedsfaktor på omkring 4 for handyr og 17 for hundyr i forhold til den terapeutiske eksponering af mennesker.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed for det aktive stof eller for et eller flere af hjælpestofferne anført i pkt.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cuprior therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Der skal tages stilling til, om der skal ophøres med amning eller med behandlingen med Cuprior under hensyntagen til fordelene ved amning for barnet og fordelen ved behandlingen for moderen.
English: Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on each side.
Danish: Gul, aflang filmovertrukket tablet, 16 mm x 8 mm, med delekærv på hver side.
English: When rodents were fed throughout pregnancy a diet containing trientine, the frequency of resorptions and the frequency of abnormal fetuses at term showed a dose-related increase.
Danish: Når gnavere gennem hele drægtighedsperioden fik foder indeholdende trientin, var der en dosisrelateret forhøjelse af frekvensen af resorptioner og frekvensen af abnorme fostre ved fødslen.
English: In mice administered in drinking water, trientine displayed increased frequencies of inflammation of the lung interstitium and liver periportal fatty infiltration.
Danish: Ved administration i drikkevandet til mus øgede trientin forekomsten af inflammation af lungernes interstitielle væv og periportal fedtinfiltration i leveren.
English: Preclinical data obtained with trientine have shown adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use as follows:
Danish: Følgende bivirkninger er ikke observeret i kliniske studier, men er set i dyrestudier efter eksponering for plasmakoncentrationer, der svarer til human-terapeutiske doser, og kan muligvis være klinisk relevante:
English: Tablet core:
Danish: Tabletkerne indhold:
English: Patients with renal impairment receiving trientine should remain under regular medical supervision for appropriate control of symptoms and copper levels.
Danish: Patienter, der har nedsat nyrefunktion og er i behandling med trientin, bør fortsætte med at være under regelmæssigt lægeligt opsyn for at kontrollere symptomer og kobberindhold tilstrækkeligt.
English: Unabsorbed trientine is eliminated through faecal excretion.
Danish: Uabsorberet trientin udskilles gennem fæces.
English: NAME OF THE MARKETING AUTHORISATION HOLDER gmp-orphan SA
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN gmp-orphan SA
English: The usual total daily dose is between 225 and 600 mg (1½ to 4 tablets daily), which will be divided into 2 to 4 smaller doses to be taken during the day.
Danish: Den normale totale dagsdosis er mellem 225 og 600 mg (1½ til 4 tabletter dagligt), som fordeles på 24 mindre doser, der tages i løbet af dagen.
English: What you need to know before you take Cuprior
Danish: Det skal du vide, før du begynder at tage Cuprior
English: Tablet film-coating:
Danish: Tablettens filmovertræk:
English: The recommended dose is between 450 mg and 975 mg (3 to 6½ film-coated tablets) per day in 2 to 4 divided doses.
Danish: Den anbefalede dosis er mellem 450 mg og 975 mg (3-6½ filmovertrukne tabletter) dagligt, fordelt på 2 til 4 separate doser.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains trientine tetrahydrochloride equivalent to 150 mg trientine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder trientintetrahydrochlorid svarende til 150 mg trientin.
English: Cuprior 150 mg film-coated tablets trientine
Danish: Cuprior 150 mg filmovertrukne tabletter trientin
English: It is unknown whether trientine is excreted in human milk.
Danish: Det vides ikke, om trientin udskilles i modermælk.
English: If you take iron supplements, make sure that at least two hours have passed between taking Cuprior and taking your iron supplements.
Danish: Hvis du får jerntilskud, skal der gå mindst to timer efter at du har taget Cuprior, før du tager jerntilskud.
English: Monitoring for manifestations of overtreatment should be undertaken, particularly when copper requirements may change, such as in pregnancy (see section 4.6) and in children where appropriate control of copper levels are required to ensure proper growth and mental development.
Danish: Der bør foretages overvågning med hensyn til manifestationer af overbehandling, navnlig når kobberbehovet kan være ændret såsom ved graviditet (se pkt.
English: Each film-coated tablet (tablet) contains trientine tetrahydrochloride equivalent to 150 mg trientine.
Danish: Hver filmovertrukket tablet (tablet) indeholder trientintetrahydrochlorid svarende til 150 mg trientin.
English: The dose is usually between 225 mg and 600 mg per day (1½ to 4 film-coated tablets) in 2 to 4 divided doses.
Danish: Den normale dosis er mellem 225 mg og 600 mg dagligt (1½-4 filmovertrukne tabletter), fordelt på 24 separate doser.
English: If you think you may have taken more Cuprior than you were told to, contact your doctor or pharmacist.
Danish: Tag kun Cuprior, som det er ordineret til dig Hvis du mener at have taget for meget Cuprior i forhold til, hvad du har fået besked på, skal du kontakte lægen eller apoteket.
English: OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets.
Danish: OPA/Alu/PVC-Alu blister.
English: - skin rashes - itching
Danish: - Hududslæt - Kløe
English: How to take Cuprior
Danish: Sådan skal du tage Cuprior
English: Swallow the tablets with water on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicines, food, or milk.
Danish: Synk tabletterne med vand på tom mave mindst én time før et måltid eller to timer efter et måltid og mindst én time før eller efter ethvert andet lægemiddel, føde eller mælk.
English: It is important that Cuprior is given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicinal product, food, or milk (see section
Danish: Det er vigtigt, at Cuprior gives på tom mave mindst én time før et måltid eller to timer efter et måltid, og mindst én time før eller efter ethvert andet lægemiddel, føde eller mælk (se pkt.
English: Manufacturer Delpharm Evreux 5 rue du Guesclin
Danish: Fremstiller Delpharm Evreux 5 rue du Guesclin 27000 Evreux Frankrig
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains trientine tetrahydrochloride equivalent to 150 mg trientine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder trientintetrahydrochlorid svarende til 150 mg trientin.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket, herunder bivirkninger, som ikke er nævnt her.
English: NAME OF THE MEDICINAL PRODUCT Cuprior 150 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Cuprior, filmovertrukne tabletter, 150 mg
English: OTHER SPECIAL WARNING(S), IF NECESSARY Take on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicine, food, or milk.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Tages på tom mave mindst én time før et måltid eller to timer efter et måltid og mindst én time før eller efter ethvert andet lægemiddel, føde eller mælk.
English: Colloidal anhydrous silica.
Danish: Silica, kolloid vandfri.
English: How to store Cuprior
Danish: Opbevaring af Cuprior
English: What Cuprior is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: As trientine is poorly absorbed following oral intake and the principal mechanism of action requires its systemic exposure (see section 5.1), it is important that the film-coated tablets are taken on empty stomach at least one hour before meals or 2 hours after meals and at least one hour apart from any other medicinal product, food, or milk (see section 4.2).
Danish: 5.1), er det vigtigt, at de filmovertrukne tabletter tages på tom mave mindst én time før et måltid eller to timer efter et måltid, og mindst én time før eller efter ethvert andet lægemiddel, føde eller mælk (se pkt.
English: Strength Pharmaceutical Form Route of administration Packaging Content (concentration) Package size
Danish: Indhold (koncentration) Pakningsstørrelse
English: It is available as tablets (0.088, 0.18, 0.35, 0.7 and 1.1 mg).
Danish: Det fås som tabletter (0,088, 0,18, 0,35, 0,7 og 1,1 mg).
English: The maximum daily dose is three 1.1 mg tablets.
Danish: Den maksimale daglige dosis er tre 1,1 mg-tabletter.
English: The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated.
Danish: Dosis øges hver femte til syvende dag, indtil symptomerne er under kontrol, uden at der forårsages bivirkninger, som ikke kan tolereres.
English: If treatment is stopped for any reason, the dose should be decreased gradually.
Danish: Hvis behandlingen af en eller anden årsag indstilles, skal dosis nedtrappes gradvist.
English: The full EPAR for Pramipexole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Pramipexole Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pramipexole Accord on 30 September 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pramipexole Accord den 30. september 2011.
English: The starting dose is one 0.088 mg tablet three times a day.
Danish: Startdosis en 0,088-mg-tablet tre gange dagligt.
English: In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Danish: Hos patienter med Parkinsons sygdom begynder de celler, der danner dopamin, at dø, og mængden af dopamin i hjernen falder.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pramipexole Accord.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Pramipexole Accord skal anvendes.
English: Pramipexole Accord 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: Pramipexole Accord 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: This is a summary of the European public assessment report (EPAR) for Pramipexole Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pramipexole Accord.
English: For more information about treatment with Pramipexole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pramipexole Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Pramipexole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Mirapexin.
Danish: Det betyder, at Pramipexole Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Mirapexin.
English: Pramipexole Accord is used to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Danish: Pramipexole Accord anvendes til behandling af symptomerne på Parkinsons sygdom, der er en fremadskridende hjernesygdom, som forårsager rysten, langsomme bevægelser og muskelstivhed.
English: Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and 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: The CHMP concluded that, in accordance with EU requirements, Pramipexole Accord has been shown to have comparable quality and to be bioequivalent to Mirapexin.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Pramipexole Accord er af sammenlignelig kvalitet og er bioækvivalent med Mirapexin.
English: Pramipexole Accord is a ‘generic medicine'.
Danish: Pramipexole Accord er et "generisk lægemiddel".
English: What measures are being taken to ensure the safe and effective use of Pramipexole Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pramipexole Accord?
English: The active substance in Pramipexole Accord, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine).
Danish: Det aktive stof i Pramipexole Accord, pramipexol, er en dopaminagonist (et stof, som efterligner virkningen af dopamin).
English: Pramipexole Accord pramipexole
Danish: Pramipexole Accord pramipexol
English: Because Pramipexole Accord 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 Pramipexole Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The Committee recommended that Pramipexole Accord be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Pramipexole Accord.
English: Therefore, the CHMP's view was that, as for Mirapexin, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Mirapexin.
English: Pramipexole Accord is a medicine that contains the active substance pramipexole.
Danish: Pramipexole Accord er et lægemiddel, der indeholder det aktive stof pramipexol.
English: Other information about Pramipexole Accord
Danish: Andre oplysninger om Pramipexole Accord
English: Because Pramipexole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Mirapexin.
Danish: Da Pramipexole Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Mirapexin.
English: What are the benefits and risks of Pramipexole Accord?
Danish: Hvilken fordel og risiko er der forbundet med Pramipexole Accord?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pramipexole Accord have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Pramipexole Accord.
English: Why has Pramipexole Accord been approved?
Danish: Hvorfor blev Pramipexole Accord godkendt?
English: What is Pramipexole Accord?
Danish: Hvad er Pramipexole Accord?
English: How has Pramipexole Accord been studied?
Danish: Hvordan blev Pramipexole Accord undersøgt?
English: Pramipexole Accord must be given less often in patients who have problems with their kidneys.
Danish: Pramipexole Accord skal gives mindre hyppigt til
English: What is Pramipexole Accord used for?
Danish: Hvad anvendes Pramipexole Accord til?
English: How is Pramipexole Accord used?
Danish: Hvordan anvendes Pramipexole Accord?
English: How does Pramipexole Accord work?
Danish: Hvordan virker Pramipexole Accord?
English: 20 mg/ml Oral drops, solution
Danish: 20 mg/ml Orale dråber, opløsning
English: Oral use bottle (glass)
Danish: Oral anvendelse flaske(glas)
English: This summary was last updated on 16 July 2012.
Danish: Dette sammendrag blev sidst ajourført i 16/07/2012.
English: 1 L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000), L interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001), L. interrogans serogroup Australis serovar Bartislava (strain As-05-073), L. kirscheneri serogrop Grippotyphosa serovar Dadas (strain Gr-01-005)).
Danish: 1 L. interrogans serogruppe Canicola, serovar Portland-vere (stamme Ca-12-000), L interrogans serogruppe Icterohaemorrhagiae, serovar Copenhageni (stame Ic-02-001), L. interrogans serogruppe Australis, serovar Bartislava (stamme As-05-073), L. kirscheneri serogruppe Grippotyphosa, serovar Dadas (stamme Gr-01-005)).
English: The company has presented data from both laboratory and field studies to establish the safety and effectiveness of the vaccine, including how long it took for the dogs to be fully protected and how long the vaccine could provide protection.
Danish: Virksomheden har fremlagt data fra både laboratorie- og feltundersøgelser med henblik på at fastsætte vaccinens sikkerhed og effektivitet, herunder hvor lang tid det tog for hundene at blive fuldt ud beskyttet, samt hvor længe vaccinen ydede beskyttelse.
English: A single ‘booster' injection should be given every year to maintain the vaccine's effect.
Danish: Hvert år bør der gives en enkelt booster-injektion, for at vaccinen kan bevare sin effekt.
English: An occasional temporary, acute (short-term) hypersensitivity (allergic) reaction may occur.
Danish: Undertiden kan der forekomme en forbigående, akut (kortvarig) overfølsom (allergisk) reaktion.
English: It contains four inactivated (killed) strains of Leptospira bacteria.1.
Danish: Den indeholder fire inaktiverede (døde) stammer af Leptospira-bakterier.1.
English: In future if the animals are exposed to the bacteria the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for bakterierne, vil immunsystemet være i stand til at reagere hurtigere.
English: The first injection can be given from six to nine weeks of age and the second four weeks later.
Danish: Den første injektion kan gives til hunde i alderen fra seks til ni uger, og den anden fire uger efter.