FrancophonIA/ELRC3.0 huggingface dataset:
English: How has Neocolipor been studied?
Danish: Hvordan blev Neocolipor undersøgt?
English: How does Neocolipor work?
Danish: Hvordan virker Neocolipor?
English: Strength Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Administration Emballage Indhold (Koncentration)
English: <EMA procedure number> <MA (EU) number> (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging <Content (concentration)> Pack size
Danish: <EMA's procedurenr.> <MF (EU)-nummer> (Særnavn) Navn Styrke Lægemiddelform Administration Emballage <Indhold (Koncentration)> Paknings-størrelse
English: 3 - How to take Keppra
Danish: 3 - Sådan skal De tage Keppra
English: Adopted at the 26-29 September 2016 PRAC
Danish: Vedtaget af PRAC 26.-29. september 2016
English: Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Keppra skal tages to gange dagligt, om morgenen og om aftenen, på omtrent samme tidspunkt hver dag.
English: Levetiracetam(oral solution) - Medication errors associated with accidental overdose (EPITT no 10519)
Danish: Levetiracetam (oral opløsning) - Medicineringsfejl forbundet med utilsigtet overdosering (EPITT nr. 10519)
English: In this population, metronidazole should therefore be used after careful benefit-risk assessment and only if no alternative treatment is available.
Danish: Hos denne population bør metronidazol derfor kun anvendes efter nøje vurdering af benefit/risk-forholdet, og kun hvis der ikke foreligger en alternativ behandlingsmulighed.
English: Dose in adults and adolescents from (16 years of age):
Danish: Dosis til voksne og unge fra (16 år):
English: When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Danish: Når De begynder at tage Keppra, vil Deres læge ordinere en lavere dosis i 2 uger, før De får den laveste vedligeholdelsesdosis.
English: Tell your doctor immediately and stop taking metronidazole if you develop:
Danish: Fortæl det straks til lægen og stop med at tage metronidazol, hvis De får:
English: Liver function tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached.
Danish: Der skal udføres leverfunktionstests umiddelbart før behandlingsstart, under hele behandlingen og efter afslutning af behandling, indtil leverfunktionstestene ligger inden for normalområderne, eller indtil baseline-værdierne er nået.
English: If the liver function tests become markedly elevated during treatment, the drug should be discontinued.
Danish: Hvis leverfunktionstestene bliver markant forhøjede under behandlingen, bør lægemidlet seponeres.
English: After measuring the correct dose with an appropriate syringe, Keppra oral solution may be diluted in a glass of water or baby's bottle.
Danish: Efter afmåling af den korrekte dosis med en passende sprøjte kan Keppra oral opløsning fortyndes i et glas vand eller en sutteflaske.
English: • Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.
Danish: • mavepine, appetitløshed, kvalme, opkastning, feber, utilpashed, træthed, gulsot, mørk urin,
English: Package leaflet (except for products for external use on the skin) 2 - What you need to know before you use metronidazole Warnings and precautions
Danish: Indlægsseddel (bortset fra lægemidler til udvortes brug på huden) 2 - Det skal De vide, før De begynder at tage metronidazol Advarsler og forsigtighedsregler
English: Metronidazole - Severe hepatic and neurologic toxicity in patients with Cockayne syndrome (EPITT no 18663)
Danish: Metronidazol - Svær hepatisk og neurologisk toksicitet hos patienter med Cockaynes syndrom (EPITT nr. 18663)
English: Summary of product characteristics (except for products for external use on the skin)
Danish: Produktresumé (med undtagelse af lægemidler til udvortes brug på huden)
English: If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with metronidazole and afterwards.
Danish: Hvis De har Cockaynes syndrom, bør Deres læge også overvåge Deres leverfunktion hyppigt under og efter behandlingen med metronidazol.
English: Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole.
Danish: Patienter med Cockaynes syndrom skal informeres om øjeblikkeligt at kontakte lægen ved ethvert symptom på en mulig leverskade og ophøre med at tage metronidazol.
English: Dose in children 6 months and older weighing less than 50 Kg Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Danish: Dosis til børn på 6 måneder og derover med vægt under 50 kg Dosis til spædbørn (6 måneder til 23 måneder), børn (2 år til 11 år) og unge (12 år til 17 år), som vejer under 50 kg:
English: Dose in infants (1 month to less than 6 months): Weight
Danish: Dosis til spædbørn (1 måned til under 6 måneder): Vægt
English: The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.
Danish: Den nøjagtige mængde oral opløsning bør indgives ved brug af sprøjten, som findes i pakningen.
English: Dose in children 6 months and older weighing less than 50 kg: Weight
Danish: Dosis til børn på 6 måneder og derover, som vejer under 50 kg: Vægt
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
Danish: Dosis til voksne og unge (12-17 år), som vejer 50 kg eller mere: Til patienter på 4 år og derover afmåles den korrekte dosis med 10 ml-sprøjten, der er vedlagt pakningen.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.
Danish: Der er rapporteret tilfælde af svær hepatotoksicitet/akut leversvigt, herunder tilfælde med dødeligt udfald og meget hurtig symptomdebut, hos patienter med Cockaynes syndrom, der har fået systemisk behandling med metronidazol.
English: Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with product containing metronidazole.
Danish: Der er rapporteret tilfælde af svær giftpåvirkning af leveren og akut leversvigt, herunder tilfælde med dødelig udgang, hos patienter med Cockaynes syndrom, efter brug af lægemidler indeholdende metronidazol.
English: General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child. (see table below for dose examples).
Danish: Sædvanlig dosis: Keppra gives to gange dagligt i to lige store doser, idet der til hver dosis afmåles mellem 0,1 ml (10 mg) og 0,3 ml (30 mg) pr. kg af barnets legemsvægt (se tabellen nedenfor, der indeholder eksempler på dosis).
English: General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day.
Danish: Den sædvanlige dosis er mellem 0,14 ml (14 mg) og 0,42 ml (42 mg) pr. kg legemsvægt dagligt, fordelt på 2 doser dagligt.
English: General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day.
Danish: Den sædvanlige dosis er mellem 0,2 ml (20 mg) og 0,6 ml (60 mg) pr. kg legemsvægt dagligt, fordelt på 2 doser dagligt.
English: General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant.
Danish: Sædvanlig dosis: Keppra gives to gange dagligt i to lige store doser, idet der til hver dosis afmåles mellem 0,07 ml (7 mg) og 0,21 ml (21 mg) pr. kg af spædbarnets legemsvægt (se tabellen nedenfor, der indeholder eksempler på dosis).
English: For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
Danish: Til spædbørn fra 1 måned til under 6 måneder afmåles den korrekte dosis ved hjælp af 1 mlsprøjten, som er vedlagt pakningen.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/130)
Danish: Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/130)
English: The European Commission issued a decision on 20 September 2019.
Danish: Europa-Kommissionen traf en afgørelse den 20. september 2019.
English: The full changes made to the product information are detailed in Annex III of the CVMP opinion under 'All documents'.
Danish: De fuldstændige ændringer, der indføres i produktinformationen, er beskrevet i bilag III til CVMP's udtalelse under "All documents".
English: Why were veterinary medicines containing tylosin reviewed?
Danish: Hvorfor blev veterinærlægemidler, der indeholder tylosin, vurderet?
English: The Committee concluded that the injection should be divided over two injection sites (maximum 2.5 ml injection volume per injection site).
Danish: Udvalget konkluderede, at injektionen bør fordeles på to injektionssteder (med en maksimal injektionsmængde pr. injektionssted på 2,5 ml).
English: Tylosin is a macrolide antibiotic used mainly to treat infections caused by bacteria known as Grampositive bacteria.
Danish: Tylosin er et makrolidantibiotikum, der hovedsagelig anvendes til behandling af infektioner forårsaget af bakterier kaldet Gram-positive bakterier.
English: The CVMP recommended the variation of the marketing authorisations for these veterinary medicines.
Danish: CVMP anbefalede en ændring af markedsføringstilladelserne for disse veterinærlægemidler.
English: In addition, cattle may also be treated by injection given slowly into a vein.
Danish: Hos kvæg kan behandlingen desuden gives ved langsom injektion i en vene.
English: Veterinary medicines containing tylosin are used in adult cattle, calves, pigs, sheep and goats and are given by injection into the muscle.
Danish: Veterinærlægemidler indeholdende tylosin anvendes til voksent kvæg, kalve, svin, får og geder og gives ved injektion i en muskel.
English: The CVMP reviewed available data on residue depletion, which indicates how long a medicine takes to fall below maximum residue limits (MRLs) in the animal's body.
Danish: CVMP gennemgik de tilgængelige data om restkoncentrationsnedbrydning, som angiver, hvor længe det tager for et lægemiddel at nå ned under maksimalgrænseværdierne for restkoncentrationer i dyrets krop.
English: The Dutch authority considered that the withdrawal periods for sheep in the EU might not be adequate to ensure consumer safety, noting that withdrawal periods differed across the EU: from 8 to 42 days for sheep meat and offal and from 4 to 7 days for sheep milk.
Danish: Den nederlandske myndighed mente, at tilbageholdelsestiderne for får i EU måske ikke var tilstrækkelige til at garantere forbrugernes sikkerhed, da tilbageholdelsestiderne i EU ikke var ens: fra 8 til 42 dage for fårekød og -indmad og fra 4 til 7 dage for fåremælk.
English: For one medicine, Tilocen, which contains the non-active ingredient polyethylene glycol 400, there were no data available that could be used to set adequate withdrawal periods in sheep.
Danish: For ét lægemiddel, Tilocen, der indeholder det ikkeaktive stof polyethylenglycol 400, var der ingen tilgængelige data, der kunne bruges til at fastsætte passende tilbageholdelsestider for får.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that for some of these medicines, the maximum injection volume per site and the withdrawal periods for sheep meat, offal and milk should be changed.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at for nogle af disse lægemidler bør den maksimale injektionsmængde pr. injektionssted og tilbageholdelsestiden for fårekød, indmad og mælk ændres.
English: Therefore, the CVMP concluded that the benefit-risk balance for the veterinary medicine Tilocen is not favourable for sheep and recommended a change to its marketing authorisation to remove any reference to use in sheep.
Danish: CVMP konkluderede derfor, at benefit/risk-forholdet for lægemidlet Tilocen ikke er gunstigt for får, og anbefalede en ændring af markedsføringstilladelsen for at fjerne alle nævnte anvendelser hos får.
English: However, for one medicine, Tilocen, the Committee concluded that there were insufficient data to determine the withdrawal period and that it should therefore no longer be used in sheep.
Danish: For ét lægemiddel, Tilocen, konkluderede udvalget imidlertid, at der ikke forelå tilstrækkelige oplysninger til at fastsætte tilbageholdelsestiden, og at lægemidlet derfor ikke længere bør anvendes til får.
English: On 20 June 2019, the European Medicines Agency completed a review of the withdrawal periods for injectable veterinary medicines containing tylosin when used in sheep.
Danish: Den 20. juni 2019 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af tilbageholdelsestiderne for injicerbare veterinærlægemidler, der indeholder tylosin og anvendes til får.
English: On 28 September 2018, the Dutch medicines authority requested that the CVMP review all available data and recommend withdrawal periods for milk, meat and offal from sheep treated with injectable veterinary medicines containing tylosin.
Danish: Den nederlandske lægemiddelmyndighed anmodede den 28. september 2018 om, at CVMP gennemgik alle tilgængelige data og anbefalede tilbageholdelsestider for mælk, kød og indmad fra får behandlet med injicerbare veterinærlægemidler, der indeholder tylosin.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that, for 49 out of 50 products, those containing benzyl alcohol and propylene glycol as a non-active ingredient, the withdrawal periods for meat and offal from treated sheep should be 42 days, while the withdrawal periods for milk from treated sheep should be 108 hours.
Danish: På grundlag af en evaluering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CVMP, at tilbageholdelsestiderne for kød og indmad fra behandlede får for 49 ud af 50 produkter bør være 42 dage, mens tilbageholdelsestiden for mælk fra behandlede får bør være 108 timer.
English: This summary was last updated in 10-2014
Danish: Dette sammendrag blev sidst ajourført i 10-2014.
English: Corbilta is used when these fluctuations cannot be treated with the standard combination alone.
Danish: Corbiltaanvendes, når disse fluktuationer ikke kan behandles med standardkombinationen alene.
English: Corbilta must not be used in patients with:
Danish: Corbiltamå ikke anvendes til patienter med:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Corbilta on 11 November 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Corbiltaden 11 november 2013.
English: Why is Corbilta approved?
Danish: Hvorfor er Corbiltablevet godkendt?
English: Patients then lose their ability to control their movements reliably.
Danish: Patienterne mister derved evnen til sikker styring af bevægelserne.
English: This medicine is the same as Stalevo, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Stalevo, som i forvejen er godkendt i EU.
English: A risk management plan has been developed to ensure that Corbilta is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Corbiltaanvendes så risikofrit som muligt.
English: The company that makes Stalevo has agreed that its scientific data can be used for Corbilta (‘informed consent').
Danish: Den virksomhed, som fremstiller Stalevo, har indvilget i, at dens videnskabelige oplysninger må anvendes for Corbilta(”informeret samtykke”).
English: The full EPAR for Corbilta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Corbiltafindes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Corbilta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Corbiltaer større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
Danish: Fluktuationer optræder, når lægemidlets virkning aftager, og symptomerne vender tilbage.
English: Having all three substances in the same tablet can lower the number of tablets patients have to take and help them stick to their treatment.
Danish: Ved at kombinere alle tre stoffer i samme tablet opnår man at mindske det antal tabletter, patienten skal tage, så det bliver lettere for patienten at overholde den ordinerede behandling.
English: The use of combinations of levodopa and carbidopa is well established, having being in use since the mid1970s.
Danish: Brugen af kombinationer af levodopa og carbidopa er almindeligt anerkendte og har været i brug siden midten af 1970'erne.
English: It is not intended to provide practical advice on how to use Corbilta.
Danish: Det er ikke en praktisk vejledning i, hvordan Corbiltabør anvendes.
English: Corbilta is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Danish: Corbiltaer et lægemiddel, der indeholder tre aktive stoffer: levodopa, carbidopa og entakapon.
English: The maximum daily dose of Corbilta is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which the maximum daily dose is seven tablets.
Danish: Den maksimale daglige dosis af Corbiltaer 10 tabletter, undtagen for tabletter indeholdende 175 mg levodopa og 43,75 mg carbidopa, hvor den maksimale daglige dosis er otte tabletter, og tabletter indeholdende 200 mg levodopa og 50 mg carbidopa, hvor den maksimale daglige dosis er syv tabletter.
English: Corbilta is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having ‘fluctuations' towards the end of the period between two doses of their medication.
Danish: Corbiltaanvendes hos patienter, der er i behandling med en kombination af levodopa og en dopadecarboxylasehæmmer (to standardlægemidler mod Parkinsons sygdom), men som har "fluktuationer" hen mod slutningen af perioden mellem to doser af medicinen.
English: Corbilta is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
Danish: Corbiltafås som tabletter i syv forskellige styrker med 50 til 200 mg levodopa og 12,5 til 50 mg carbidopa.
English: Both carbidopa and entacapone block some of the enzymes that are involved in the breakdown of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, and entacapone blocks the enzyme catechol-O-methyl transferase (COMT).
Danish: Både carbidopa og entakapon hæmmer nogle af de enzymer, der medvirker ved nedbrydning af levodopa i kroppen: Carbidopa hæmmer enzymet dopadecarboxylase, og entakapon hæmmer enzymet catechol-O-methyltransferase (COMT).
English: The most common side effects with Corbilta (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), aggravated Parkinsonism (worsening of Parkinson's disease), nausea (feeling sick) and harmless urine discoloration.
Danish: De almindeligste bivirkninger ved Corbilta(som optræder hos flere end 1 ud af 10 patienter) er ufrivillige bevægelser (dyskinesi), forværring af Parkinsons sygdom, kvalme og harmløs misfarvning af urinen.
English: All of the active substances in Corbilta work to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Danish: De aktive stoffer i Corbiltagenopretter indholdet af dopamin i de dele af hjernen, der styrer bevægelser og koordination.
English: Serious side effects which have been reported much less often include gastrointestinal haemorrhage (bleeding in the gut) and angioedema (swelling under the skin of face or limbs).
Danish: Alvorlige bivirkninger, der er blevet indberettet i meget mindre omfang, er blødninger fra tarmen (gastrointestinale blødninger) og hævelse under huden i ansigtet eller på arme og ben (angioødem).
English: Levodopa / carbidopa / entacapone
Danish: Levodopa / carbidopa / entakapon
English: Levodopa is converted into dopamine in the brain.
Danish: Levodopa omdannes i hjernen til dopamin.
English: The company used some of the data from Comtess/Comtan (entacapone) to support the use of Corbilta and presented data from the published literature for the use of the combination of levodopa and carbidopa.
Danish: Virksomheden anvendte nogle af oplysningerne fra Comtess/Comtan (entakapon) som dokumentation for anvendelsen af Corbiltaog fremlagde desuden oplysninger fra litteraturen om anvendelsen af levodopa og carbidopa i kombination.
English: For the full list of all side effects reported with Corbilta, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Corbiltafremgår af indlægssedlen.
English: They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Danish: De skyldes den aftagende virkning af levodopa, hvor patienten oplever pludselige skift mellem "on-perioder", hvor patienten kan bevæge sig, og "off-perioder", hvor patienten har svært ved at bevæge sig.
English: The company carried out ‘bioequivalence' studies to show that taking Corbilta produces the same levels of levodopa, carbidopa and entacapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Danish: Virksomheden foretog undersøgelser af “bioækvivalens” til påvisning af, at Corbiltagiver samme koncentration i blodet af levodopa, carbidopa og entakapon, som når de aktive stoffer tages som separate tabletter dels indeholdende entakapon, dels en kombination af levodopa og carbidopa.
English: It is used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Danish: Det anvendes til behandling af voksne patienter med Parkinsons sygdom, der er en fremadskridende hjernesygdom, som medfører rysten, langsomme bevægelser og muskelstivhed.
English: • phaeochromocytoma (a tumour of the adrenal gland);
Danish: • fæokromocytom (en svulst i binyrerne)
English: The strength of Corbilta that the patient should use is based on the amount of levodopa they need to control their symptoms.
Danish: Den styrke af Levodopa/Carbidopa/Entacapone Sandoz, patienten skal anvende, afhænger af den mængde levodopa, der er nødvendig til kontrol af patientens symptomer.
English: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Danish: • tidligere malignt neuroleptikasyndrom (en farlig nervesygdom, sædvanligvis forårsaget af antipsykotiske lægemidler) eller nedbrydning af muskelfibrene (rhabdomyolyse) Corbiltamå ikke anvendes sammen med andre antidepressive lægemidler i gruppen monoaminoxidasehæmmere.