FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is recommended (see section 5.2).
Danish: Der er ingen anbefalinger om dosisjustering (se pkt.
English: Doptelet 20 mg tablets avatrombopag
Danish: Doptelet 20 mg tabletter avatrombopag
English: P-gp and moderate CYP3A inhibitor
Danish: P-gp- og moderat CYP3A-hæmmer
English: Once-daily dose
Danish: Dosis en gang dagligt
English: How to take Doptelet
Danish: Sådan skal du tage Doptelet
English: Doptelet 20 mg film-coated tablets avatrombopag
Danish: Doptelet 20 mg filmovertrukne tabletter avatrombopag
English: Doptelet 20 mg film-coated tablets
Danish: Doptelet 20 mg filmovertrukne tabletter
English: Hypersensitivity to avatrombopag or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for avatrombopag eller over for et eller flere af hjælpestofferne anført i pkt.
English: CYP3A4/5 and CYP2C9 inhibitors
Danish: CYP3A4/5- og CYP2C9-hæmmere
English: Moderate CYP3A and CYP2C9 inhibitor
Danish: Moderat CYP3A- og CYP2C9-hæmmer
English: A measured increase in platelet counts was observed in both avatrombopag treatment groups over time beginning on Day 4 post-dose, which peaked on Day 10-13 and then returned to near baseline values by Day 35 (Figure 1); mean platelet count remained greater than or equal to 50 x 109/L on Day 17 (Visit 5).
Danish: Tallene nåede deres højeste værdier på dag 10-13 og var vendt tilbage til værdier nær baseline på dag 35 (figur 1).
English: Macrogol 3350 (E1521) Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Filmovertræk Polyvinylalkohol (E1203) Talcum (E553b) Macrogol 3350 (E1521) Titandioxid (E171) Gul jernoxid (E172)
English: Strong CYP3A inhibitor
Danish: Stærk CYP3A-hæmmer
English: The predominant route of avatrombopag excretion is via faeces.
Danish: Avatrombopag udskilles overvejende via fæces.
English: In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 31.1 x 109/L and for placebo-treated patients was 30.7 x 109/L.
Danish: I kohorten med lavt trombocyttal ved baseline var det gennemsnitlige trombocyttal ved baseline for den gruppe, der fik behandling med avatrombopag, 31,1 x 109/l, og for den gruppe, der fik placebo, var det 30,7 x 109/l.
English: If you are not sure, talk to your doctor or pharmacist before taking Doptelet.
Danish: Tal med lægen eller apotekspersonalet, inden du tager Doptelet, hvis du er i tvivl.
English: In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 32.7 x 109/L and for placebo-treated patients was 32.5 x 109/L.
Danish: I kohorten med lavt trombocyttal ved baseline var det gennemsnitlige trombocyttal ved baseline for den gruppe, der fik behandling med avatrombopag, 32,7 x 109/l, og for den gruppe, der fik placebo, var det 32,5 x 109/l.
English: What Doptelet is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Bone pain Myalgia
Danish: Knoglesmerter Myalgi
English: Avatrombopag has not been studied in patients with severe renal impairment (see section 5.2); however, given the short duration of treatment, no dose adjustment is recommended.
Danish: 5.2), men på grund af behandlingens korte varighed gives der ingen anbefalinger om dosisjustering.
English: In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.9 x 109/L.
Danish: I kohorten med højt trombocyttal ved baseline var det gennemsnitlige trombocyttal ved baseline for de patienter, der fik behandling med avatrombopag, 44,3 x 109/l, og for den gruppe, der fik placebo, var det 44,9 x 109/l.
English: If you take more Doptelet than you should
Danish: Hvis du har taget for meget Doptelet
English: In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.5 x 109/L.
Danish: I kohorten med højt trombocyttal ved baseline var det gennemsnitlige trombocyttal ved baseline for de patienter, der fik behandling med avatrombopag, 44,3 x 109/l, og for den gruppe, der fik placebo, var det 44,5 x 109/l.
English: Musculoskeletal & connective tissue disorders
Danish: Knogler, led, muskler og bindevæv
English: What Doptelet looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: If any of the above applies to you, or you are not sure, talk to your doctor or pharmacist before taking Doptelet.
Danish: Tal med lægen eller apotekspersonalet, inden du tager Doptelet, hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl.
English: Memantine Accord should be given once a day at the same time every day.
Danish: Memantine Accord skal gives én gang dagligt på samme klokkeslæt hver dag.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Accord on 04 December 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Memantine Accord den 04. december 2013.
English: Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Danish: Behandlingen bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom.
English: The full EPAR for Memantine 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 Memantine Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Memantine Accord is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription.
Danish: Memantine Accord leveres som tabletter (5 mg, 10 mg, 15 mg og 20 mg) og udleveres kun efter recept.
English: This is a summary of the European public assessment report (EPAR) for Memantine Accord.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Memantine Accord.
English: It is used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Danish: Det anvendes til behandling af moderat til svær Alzheimers sygdom, som er en hjernesygdom (en form for demens), der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine Accord should be re-assessed on a regular basis.
Danish: Tolerance og dosis bør vurderes inden for 3 måneder efter behandlingens start, og herefter bør der regelmæssigt igen tages stilling til fordelene ved at fortsætte behandlingen med Memantine Accord.
English: To prevent side effects, the dose of Memantine Accord is gradually increased over the first three weeks of treatment: during the first week, the daily dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Danish: For at undgå bivirkninger øges dosis af Memantine Accord gradvist i løbet af de tre første uger af behandlingen: I den første uge er den daglige dosis 5 mg, i den anden uge er den 10 mg, og i den tredje uge er den 15
English: Memantine works by blocking types of receptors called N-methyl-D-aspartate (NMDA) receptors, to which the neurotransmitter glutamate normally attaches.
Danish: Memantin virker ved at blokere NMDA- (N-methyl-D-aspartat-) receptorerne, som signalstoffet glutamat normalt bindes til.
English: A risk management plan has been developed to ensure that Memantine Accord is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Memantine Accord anvendes så risikofrit som muligt.
English: ‘Bioequivalent' means that the medicines are expected to produce the same levels of the active substance in the body.
Danish: At lægemidlerne er bioækvivalente, vil sige, at de forventes at frembringe samme mængde aktivt stof i kroppen.
English: This means that Memantine Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Axura.
Danish: Det betyder, at Memantine Accord er identisk med et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU).
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine Accord by the patient.
Danish: Behandlingen bør kun iværksættes, hvis patienten har en omsorgsgiver, der regelmæssigt overvåger patientens indtagelse af Memantine Accord.
English: Other information about Memantine Accord
Danish: Andre oplysninger om Memantine Accord
English: Memantine Accord is a ‘generic medicine'.
Danish: Memantine Accord er et “generisk lægemiddel”.
English: Because Memantine 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 Memantine Accord er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
English: What are the benefits and risks of Memantine Accord?
Danish: Hvilke fordele og risici er der forbundet med Memantine Accord?
English: The active substance in Memantine Accord, memantine, is an antidementia medicine.
Danish: Det aktive stof i Memantine Accord, memantin, er et lægemiddel mod demens.
English: Memantine Accord is a medicine that contains the active substance memantine.
Danish: Memantine Accord er et lægemiddel, der indeholder det aktive stof memantin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Accord has been shown to have comparable quality and is considered bioequivalent to Axura.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Memantine Accord er af sammenlignelig kvalitet og anses for at være bioækvivalent med Axura.
English: Memantine Accord memantine
Danish: Memantine Accord memantin
English: What measures are being taken to ensure the safe and effective use of Memantine Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Memantine Accord?
English: For more information about treatment with Memantine 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 Memantine Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Memantine Accord and what is it used for?
Danish: Hvad er Memantine Accord, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Memantine Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Memantine Accord bør anvendes.
English: The Committee recommended that Memantine Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at det godkendes til anvendelse i EU.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Memantine Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Memantine Accord er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: No additional studies in patients were required as Memantine Accord was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Axura.
Danish: Der krævedes ikke yderligere undersøgelser hos patienter, fordi Memantine Accord blev påvist at være af tilsvarende kvalitet som referencelægemidlet Axura og at være bioækvivalent med dette.
English: For practical information about using Memantine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Memantine Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Memantine Accord approved?
Danish: Hvorfor er Memantine Accord blevet godkendt?
English: The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Danish: Ved moderat eller svær nyresygdom kan lavere dosis være nødvendig.
English: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Danish: Derved forbedres signaloverførslen i hjernen, så symptomerne på Alzheimers sygdom mindskes.
English: How is Memantine Accord used?
Danish: Hvordan anvendes Memantine Accord?
English: How has Memantine Accord been studied?
Danish: Hvordan blev Memantine Accord undersøgt?
English: Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Danish: Hukommelsessvækkelsen ved Alzheimers sygdom er blevet sat i forbindelse med ændringer i signaloverførslen via glutamat i hjernen.
English: How does Memantine Accord work?
Danish: Hvordan virker Memantine Accord?
English: Although this difference is not large, it may benefit some patients.
Danish: Skønt denne forskel ikke er stor, kan den være til fordel for visse patienter.
English: It is given once only, within 48 hours after symptoms start.
Danish: Det gives kun én gang, højst 48 timer efter at symptomerne er sat ind.
English: Further information on Alpivab can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Alpivab findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: There is a risk of severe allergic reactions, and although it is not known exactly how often these reactions occur, they appear to be rare.
Danish: Der er risiko for svære allergiske reaktioner, som synes at være sjældne, skønt det ikke vides nøjagtigt, hvor ofte de forekommer.
English: Alpivab is given as an infusion lasting 15 to 30 minutes.
Danish: Alpivab gives som en infusion, der varer 15-30 minutter.
English: As for all medicines, data on the use of Alpivab are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Alpivab løbende overvåget.
English: The dose depends on age and body weight and should be reduced in adults and adolescents over 13 years of age with reduced kidney function.
Danish: Dosis afhænger af alder og legemsvægt og bør reduceres hos voksne og unge over 13 år med nedsat nyrefunktion.
English: Other information about Alpivab
Danish: Andre oplysninger om Alpivab
English: It is used to treat uncomplicated influenza (flu) in adults and children over 2 years.
Danish: Det anvendes til behandling af ukompliceret influenza hos voksne og børn over 2 år.
English: For more information about using Alpivab, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Alpivab, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency decided that Alpivab's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Alpivab opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Alpivab and what is it used for?
Danish: Hvad er Alpivab, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Alpivab?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Alpivab?
English: Side effects reported with Alpivab are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Alpivab vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Alpivab and why it is authorised in the EU
Danish: En oversigt over Alpivab og hvorfor det er godkendt i EU
English: Alpivab was shown to reduce the length of time symptoms lasted in patients with influenza.
Danish: Alpivab er påvist at reducere den tid, symptomerne varede, hos patienter med influenza.
English: Why is Alpivab authorised in the EU?
Danish: Hvorfor blev Alpivab godkendt i EU?
English: Peramivir works on neuraminidases of both influenza-A (the most common type) and influenza-B viruses.
Danish: Peramivir virker på neuraminidaser hos både influenza A- (det mest almindelige) og influenza B-virus.
English: Uncomplicated means that the flu has typical features (such as fever, aches, cough, sore throat and runny nose) and is not made worse by other conditions.
Danish: Ukompliceret vil sige, at influenzaen har typiske kendetegn (såsom feber, ømhed, hoste, ondt i halsen og løbende næse) og ikke er forværret af andre sygdomme.
English: The active substance in Alpivab, peramivir, prevents the flu virus from spreading further by blocking the activity of enzymes (proteins) on the surface of the virus called neuraminidases.
Danish: Det aktive stof i Alpivab, peramivir, forhindrer influenzavirus i at spredes yderligere ved at blokere aktiviteten af enzymer, der er proteiner af typen neuraminidaser, på virussets overflade.
English: Symptoms took around 2 and a half days (59 hours) to get better in patients taking Alpivab in comparison with just under 3 and a half days (82 hours) in patients taking placebo.
Danish: Det varede ca. 2,5 døgn (59 timer), før symptomerne blev bedre, hos patienter, der fik Alpivab, sammenholdt med lidt under 3,5 døgn (82 timer) hos patienter, der fik placebo.
English: What are the risks associated with Alpivab?
Danish: Hvilke risici er der forbundet med Alpivab?
English: Serious side effects with Alpivab are anaphylaxis (a severe allergic reaction) and skin reactions, including erythema multiforme (an allergic skin reaction) and Stevens-Johnson Syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Danish: Alvorlige bivirkninger med Alpivab er anafylaksi (en svær allergisk reaktion) og hudreaktioner, herunder erythema multiforme (en allergisk hudreaktion) og Stevens-Johnsons syndrom (en livstruende allergisk reaktion med influenzalignende symptomer og smertefuldt udslæt på hud, mund, øjne og kønsdele).
English: Alpivab was compared with placebo (a dummy treatment) in one main study of 296 adults with influenza (mostly influenza A) treated within 48 hours of symptoms appearing.
Danish: Alpivab er blevet sammenlignet med placebo (en uvirksom behandling) i et hovedstudie, der omfattede 296 voksne med influenza (hovedsagelig influenza A), der blev behandlet senest 48 timer efter, at symptomerne satte ind.
English: Alpivab is an antiviral medicine that contains the active substance peramivir.
Danish: Alpivab er et lægemiddel mod virus (et antiviralt lægemiddel), der indeholder det aktive stof peramivir.
English: The most common side effects with Alpivab (which may affect up to around 3 in 100 people) are a decrease in the levels of neutrophils (a type of white blood cell) and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Alpivab (som kan forekomme hos op til 3 ud af 100 personer) er et nedsat antal hvide blodlegemer af typen neutrofiler samt kvalme.
English: For the full list of side effects and restrictions with Alpivab, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Alpivab fremgår af indlægssedlen.
English: Alpivab reduces the length of time flu symptoms last by one day on average.
Danish: Alpivab nedsætter varigheden af influenzasymptomer med gennemsnitligt en dag.
English: The main measure of effectiveness was the length of time before symptoms (cough, sore throat, headache, blocked nose, feverishness or chills, aches or pains of the muscle or joints and tiredness) got better.
Danish: Virkningen blev hovedsagelig bedømt på den tid, der gik, før der var bedring i symptomerne (hoste, ondt i halsen, hovedpine, tilstoppet næse, feber eller kulderystelser, ømhed eller smerter i muskler eller led, og træthed).
English: How is Alpivab used?
Danish: Hvordan anvendes Alpivab?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alpivab 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 Alpivab.
English: What benefits of Alpivab have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Alpivab?
English: How does Alpivab work?
Danish: Hvordan virker Alpivab?
English: Alpivab is available as a solution to be diluted for infusion (drip) into a vein.
Danish: Alpivab fås som en opløsning, der efter fortynding indgives med drop (ved infusion) i en blodåre.
English: The mutual recognition procedure (UK/V/0356/001/MR) started on 26 November 2009.
Danish: Den gensidige anerkendelsesprocedure (UK/V/0356/001/MR) indledtes den 26. November 2009.
English: On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by a Concerned Member States, France, that the safety and efficacy of the product had not been sufficiently demonstrated.
Danish: Den 2. juli 2010 indbragte Det Forenede Kongerige som referencemedlemsstat sagen for Det Europæiske Lægemiddelagentur i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, eftersom en berørt medlemsstat, Frankrig, havde udtrykt bekymring for, at der ikke var fremlagt tilstrækkelig dokumentation for produktets sikkerhed og virkning.
English: The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Combisyn via a mutual recognition procedure in Austria, Belgium, Denmark, Finland, France, Portugal and Spain on the basis of the marketing authorisation granted by the United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen, Norbrook Laboratories Ltd, indgav en ansøgning vedrørende Combisyn via en gensidig anerkendelsesprocedure i Østrig, Belgien, Danmark, Finland, Frankrig, Portugal og Spanien på grundlag af den markedsføringstilladelse, der er udstedt af Det Forenede Kongerige.
English: There was disagreement between the Reference Member State and the Concerned Member States on the demonstration of bioequivalence and the adequacy of the proposed withdrawal period.
Danish: Der var uenighed blandt referencemedlemsstaten og de berørte medlemsstater om påvisningen af bioækvivalens og hensigtsmæssigheden af den foreslåede tilbageholdelsestid.
English: Combisyn is intended for the treatment of mastitis in lactating cows.
Danish: Combisyn er beregnet til behandling af mastitis hos diegivende kvæg.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Combisyn Lactating Cow Intramammary Suspension is negative, and therefore adopted an opinion on 6 April 2011 recommending the refusal of the granting of the marketing authorisations and suspension of the existing marketing authorisation.
Danish: På grundlag af evalueringen af rapportørens vurdering af de aktuelt foreliggende data var CVMP af den opfattelse, at risk/benefit-forholdet for Combisyn Lactating Cow Intramammary Suspension er negativ, og vedtog derfor den 6. april 2011 en udtalelse, der anbefaler afslag på ansøgningen om markedsføringstilladelserne og suspendering af den eksisterende markedsføringstilladelse.