FrancophonIA/ELRC3.0 huggingface dataset:
English: On 4 June 2008 the National Competent Authorities of the Member States were requested to provide the missing information for the outstanding 120 Marketing Authorisations.
Danish: Den 4. juni 2008 blev de nationale kompetente myndigheder anmodet om at indsende de manglende oplysninger for de resterende 120 markedsføringstilladelser.
English: During its 10-12 March 2009 meeting, the CVMP, appointed Dr A. Holm as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur for the re-examination of the above mentioned opinion.
Danish: CVMP udpegede på sit møde den 10.-12. marts 2009 dr. A. Holm som rapportør og dr. M. Holzhauser-Alberti som medrapportør for revurderingen af ovennævnte udtalelse.
English: Eighteen Member States responded and submitted information concerning 103 of the outstanding 120 Marketing Authorisations.
Danish: 18 medlemsstater svarende og indsendte oplysninger om 103 af de resterende 120 markedsføringstilladelser.
English: Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that its opinion of 11 February 2009 should be revised.
Danish: På grundlag af vurderingen af de aktuelt foreliggende data og rapportørernes vurdering var CVMP af den opfattelse, at udvalgets udtalelse af 11. februar 2009 skulle revideres.
English: On 25 February 2009, Norbrook Laboratories Ltd, notified the EMEA of its intention to request the reexamination of the CVMP opinion of 11 February 2009.
Danish: Den 25. februar 2009 meddelte Norbrook Laboratories Ltd EMEA, at virksomheden havde til hensigt at anmode om en revurdering af CVMP's udtalelse af 11. februar 2009.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics, package leaflet and label in the Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, og det ændrede produktresumé, etikettering og indlægsseddel findes i bilag III.
English: Written explanations were provided by the Marketing Authorisation Holders on 13 November 2008.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 13. november 2008.
English: Further to the resignation of Prof R. Kroker as CVMP member, Dr C. Ibrahim was appointed to replace him and took over the co-rapporteurship.
Danish: Som følge af, at prof. R. Kroker trak sig som medlem af CVMP, blev dr. C. Ibrahim udpeget til at afløse ham og overtog medrapportørfunktionen.
English: Ivermectin belongs to the macrocyclic lactone class of endectocides with activity against a wide rage of internal and external parasites.
Danish: Ivermectin tilhører klassen af makrocykliske lactoner i endectociderne og virker mod en lang række interne og eksterne parasitter.
English: Injectable veterinary medicinal products containing ivermectin, either as a single active substance or in combination with a second active substance are indicated for use in cattle for the treatment of endoparasitic and ectoparasitic infestations.
Danish: Injicerbare veterinærlægemidler indeholdende ivermectin enten som et enkelt aktivt stof eller i kombination med et andet aktivt stof er indiceret til anvendelse i kvæg til behandling af endoparasitiske og ektoparasitiske sygdomme.
English: Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that a single withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin.
Danish: På grundlag af vurderingen af de aktuelt foreliggende data og rapportørernes vurdering var CVMP af den opfattelse, at der skulle fastsættes en enkelt tilbageholdelsesperiode på 49 dage for alle injicerbare lægemidler til kvæg indeholdende ivermectin.
English: With regard to the products containing ivermectin in combination with clorsulon as a second active substance a withdrawal period of 66 days for cattle was recommended.
Danish: Med hensyn til lægemidler indeholdende ivermectin i kombination med clorsulon som et andet aktivt stof blev der anbefalet en tilbageholdelsesperiode på 66 dage for kvæg.
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Injectable veterinary medicinal products containing ivermectin that are indicated for use in cattle at dose of 200 μg ivermectin per kg bodyweight
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 351 OM Injicerbare veterinærlægemidler indeholdende ivermectin, som er indiceret til anvendelse i kvæg i en dosis a 200 μg ivermectin pr. kg kropsvægt
English: Therefore, the Committee adopted an opinion on 11 February 2009 recommending the variation of the existing Marketing Authorisations in accordance with the recommended amendments to the Summary of Product Characteristics.
Danish: Udvalget vedtog derfor en udtalelse den 11. februar 2009, hvori det anbefalede godkendelse af ændringen af de eksisterende markedsføringstilladelser i overensstemmelse med de foreslåede ændringer af produktresuméet.
English: Therefore, the Committee adopted by written procedure an opinion on 5 June 2009 recommending the variation the existing Marketing Authorisations in line with the proposed amendments of the Summary of Product Characteristics, labelling and package leaflet.
Danish: Udvalget vedtog derfor ved skriftlig procedure en udtalelse den 5. juni 2009, hvori det anbefalede ændring af den eksisterende markedsføringstilladelse i overensstemmelse med de foreslåede ændringer af produktresumé, etikettering og indlægsseddel.
English: The withdrawal period of 49 days for cattle would also apply to all concerned injectable products containing ivermectin in combination with closantel as a second active substance.
Danish: Tilbageholdelsesperioden på 49 dage for kvæg skulle også finde anvendelse på alle berørte injicerbare lægemidler indeholdende ivermectin i kombination med closantel som et andet aktivt stof.
English: The Committee confirmed that a withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin as a single active substance.
Danish: Udvalget bekræftede, at der skulle fastsættes en tilbageholdelsesperiode på 49 dage for alle de berørte injicerbare lægemidler til kvæg indeholdende ivermectin som et enkelt aktivt stof.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nuedexta on 24 June 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nuedexta den 24. juni 2013.
English: This is a summary of the European public assessment report (EPAR) for Nuedexta.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nuedexta.
English: Nuedexta must not be used in patients:
Danish: Nuedexta må ikke anvendes til patienter:
English: The CHMP also noted that there is currently no treatment available for this distressing condition.
Danish: CHMP bemærkede desuden, at der på nuværende tidspunkt ikke findes behandlingsmuligheder for denne belastende sygdom.
English: The full EPAR for Nuedexta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Nuedexta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was based on the reduction in the number of episodes of laughing or crying.
Danish: Behandlingens virkning blev hovedsagelig bedømt på reduktionen i antallet af episoder med latter eller gråd.
English: Other information about Nuedexta
Danish: Andre oplysninger om Nuedexta
English: A risk management plan has been developed to ensure that Nuedexta is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Nuedexta anvendes så risikofrit som muligt.
English: The main safety issues were considered manageable and adequately addressed by risk minimisation measures.
Danish: Udvalget fandt, at de vigtigste sikkerhedsproblemer kunne behandles og håndteres tilfredsstillende gennem risikominimeringsforanstaltninger.
English: • with ‘prolonged QT interval' (a disruption of the electrical activity of the heart);
Danish: • med “forlænget QT-interval” (en forstyrrelse i hjertets elektriske aktivitet),
English: • who are taking the medicine thioridazine used for mental illness;
Danish: • som får lægemidlet thioridazin, der anvendes ved psykiske sygdomme,
English: Regarding its safety, the CHMP decided that dextromethorphan and quinidine have been marketed as medicines for a number of years and their safety and interactions with other medicines are relatively well known.
Danish: Vedrørende sikkerheden konkluderede CHMP, at dextromethorphan og kinidin har været markedsført som lægemidler i en årrække, og at deres sikkerhed og interaktion med andre lægemidler er forholdsvis velkendte.
English: A decrease in the total score indicates an improvement in PBA symptoms.
Danish: Et fald i total score betyder en bedring i symptomerne på PBA.
English: Nuedexta was compared with placebo (a dummy treatment) for 12 weeks.
Danish: Nuedexta blev sammenlignet med placebo (virkningsløs behandling) i 12 uger.
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 Nuedexta.
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 anvendelsesbetingelserne for Nuedexta.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nuedexta'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) konkluderede, at fordelene ved Nuedexta er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Dextromethorphan / quinidine
Danish: Nuedexta dextromethorphan/kinidin
English: For more information about treatment with Nuedexta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nuedexta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Nuedexta (which may affect up to 1 in 10 people) are diarrhoea, nausea (feeling sick), dizziness, headache, somnolence (sleepiness) and fatigue (tiredness).
Danish: De hyppigste bivirkninger med Nuedexta (som kan forekomme hos op til en ud af 10 behandlede) er diarré, kvalme, svimmelhed, hovedpine, søvnighed og træthed.
English: After 12 weeks of treatment with Nuedexta, the CNS-LS score decreased by 8.2 points, compared with a decrease of 5.7 points for placebo.
Danish: Efter 12 ugers behandling med Nuedexta var der et fald i CNS-LS-score på 8,2 point, sammenholdt med et fald på 5,7 point med placebo.
English: What is Nuedexta and what is it used for?
Danish: Hvad er Nuedexta, og hvad anvendes det til?
English: The study also measured the change in the patients' symptoms, assessed in several ways including using a standard scale (called a CNS-LS score which ranges from 7 to 35).
Danish: I undersøgelserne måltes desuden ændringen i symptomer, vurderet på forskellige måder, herunder standardskalaen CNS-LS-score, der går fra 7 til 35.
English: It is used to treat the symptoms of pseudobulbar affect (PBA) in adults.
Danish: Det anvendes til behandling af symptomerne på pseudobulbær affekt (PBA) hos voksne.
English: Why has Nuedexta been approved?
Danish: Hvorfor er Nuedexta blevet godkendt?
English: Since these neurotransmitters are involved in the control of emotions, dextromethorphan helps to normalise its activity in the brain, reducing the symptoms of PBA.
Danish: Eftersom disse neurotransmittere er involveret i kontrollen over følelserne, normaliserer dextromethorphan hjerneaktiviteten og mindsker derved symptomerne på PBA.
English: Nuedexta is a medicine that contains two active substances, dextromethorphan and quinidine.
Danish: Nuedexta er et lægemiddel, der indeholder to aktive stoffer: dextromethorphan og kinidin.
English: • who are already being treated with the medicines quinidine, quinine or mefloquine or who have previously developed certain serious problems such as thrombocytopenia (low platelet counts) due to the use of these medicines;
Danish: • som i forvejen er i behandling med lægemidlerne kinidin, kinin eller mefloquin, eller som tidligere har fået alvorlige problemer såsom trombocytopeni (for lavt antal blodplader) ved brug af disse lægemidler,
English: PBA is a condition where damage to certain areas of the brain results in sudden and uncontrollable episodes of crying or laughing that do not relate to the patient's real emotional state.
Danish: PBA er en sygdom, der medfører ufrivillige og ukontrollerbare episoder med latter og gråd, som ikke svarer til patientens reelle følelser eller sindsstemning.
English: The company will also carry out a study on the use of Nuedexta and a study to monitor Nuedexta's safety including its effects on the heart and potential for interactions with other medicines.
Danish: Virksomheden skal derudover udføre en undersøgelse af anvendelsen af Nuedexta og en undersøgelse til overvågning af sikkerheden af Nuedexta, herunder dets virkninger på hjertet og muligheden for interaktion med andre lægemidler.
English: What measures are being taken to ensure the safe use of Nuedexta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Nuedexta?
English: Serious side effects reported include muscle spasticity (excessive stiffness of muscles), respiratory depression (inhibition of breathing) and decreased oxygen saturation (lower-than-normal levels of oxygen) in the blood.
Danish: De indberettede alvorlige bivirkninger omfatter spasticitet (unormal muskelstivhed), nedsat vejrtrækning og nedsat iltmætning i blodet.
English: Although the exact way dextromethorphan works in PBA is unclear, it attaches to several different nerve cell receptors in the brain such as NMDA receptors and sigma-1 receptors for the neurotransmitter glutamate as well as receptors for the neurotransmitter serotonin.
Danish: Det vides ikke nøjagtigt, hvordan dextromethorphan virker ved PBA, men stoffet bindes til forskellige nervecellereceptorer i hjernen såsom NMDA-receptorer og sigma-1-receptorer for neurotransmitteren glutamat og til receptorer for neurotransmitteren serotonin.
English: What is the risk associated with Nuedexta?
Danish: Hvilken risiko er der forbundet med Nuedexta?
English: Nuedexta is available as capsules (15 mg or 23 mg dextromethorphan and 9 mg quinidine) and can only be obtained with a prescription.
Danish: Nuedexta leveres som kapsler (15 mg eller 23 mg dextromethorphan og 9 mg kinidin).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nuedexta, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Nuedexta, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
English: Nuedexta has been studied in one main study involving 326 patients with PBA due to multiple sclerosis or amyotrophic lateral sclerosis.
Danish: Nuedexta var genstand for én hovedundersøgelse hos 326 patienter med PBA som følge af multipel sklerose eller amyotrofisk lateralsklerose.
English: In patients whose response is inadequate after four weeks, the higher strength capsule (23mg/9mg) may be used twice a day.
Danish: Er virkningen ikke tilstrækkelig efter fire uger, kan dosis forhøjes til én kapsel af den høje styrke (23 mg/9 mg) to gange dagligt.
English: • with a history suggestive of torsades de pointes ventricular tachycardia (abnormal heart rhythms);
Danish: • med en sygehistorie, der tyder på ventrikulær takykardi af typen torsade de pointes (abnorm hjerterytme),
English: • with or at high risk of complete AV block (a type of heart rhythm disorder);
Danish: • som enten lider af eller har høj risiko for fuldstændigt AV-blok (en form for forstyrrelse i hjerterytmen),
English: The CHMP concluded that Nuedexta is effective in treating the symptoms of PBA based on the studies in patients with PBA caused by multiple sclerosis and amyotrophic lateral sclerosis.
Danish: CHMP konkluderede, at Nuedexta er effektivt til at behandle symptomerne på PBA baseret på undersøgelserne hos patienter med PBA forårsaget af dissemineret sklerose eller amyotrofisk lateralsklerose.
English: Treatment with Nuedexta was effective in reducing patients' PBA episodes which were reduced by nearly 50% more than in patients treated with placebo.
Danish: Hos patienter behandlet med Nuedexta faldt antallet af PBA-episoder næsten 50 % mere end hos patienter behandlet med placebo.
English: Although the exact cause of PBA is unclear, it is believed that it affects the way signals are transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Danish: Den nøjagtige årsag til PBA kendes ikke, men sygdommen menes at afbryde hjernecellernes indbyrdes kommunikation gennem neurotransmittere, dvs. kemiske signalstoffer.
English: Treatment should be started with one lower strength capsule (15mg/9mg) once a day (in the morning), which is increased after one week to twice a day (in the morning and evening, 12 hours apart).
Danish: Behandlingen bør påbegyndes med én kapsel af den lave styrke (15 mg/9 mg) én gang dagligt (om morgenen).
English: The role of quinidine is to prevent dextromethorphan from being broken down early in the body and thereby it prolongs the action of dextromethorphan in the body.
Danish: Kinidins funktion er at forhindre for hurtig nedbrydning af dextromethorphan, som derved virker i længere tid.
English: For the full list of all side effects reported with Nuedexta, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Nuedexta fremgår af indlægssedlen.
English: How is Nuedexta used?
Danish: Hvordan anvendes Nuedexta?
English: In addition, the company that makes Nuedexta must ensure that all healthcare professionals who are expected to use Nuedexta receive an information pack and a patient alert card with key safety information.
Danish: Den virksomhed, der fremstiller Nuedexta, skal desuden udlevere en informationspakke og et patientadvarselskort med de vigtigste sikkerhedsoplysninger til alle sundhedspersoner, der forventes at anvende Nuedexta.
English: What benefits of Nuedexta have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Nuedexta?
English: How does Nuedexta work?
Danish: Hvordan virker Nuedexta?
English: • who are taking or have taken within the last 14 days medicines for depression called monoamine oxidase inhibitors (MAOI).
Danish: • som er i behandling med MAO-hæmmere (lægemidler mod depression) eller har været det inden for de seneste 14 dage.
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, administrationsveje, indehavere af markedsføringstilladelser i Medlemsstaterne
English: Intravenous/ Intramuscular
Danish: Intravenøs/ Intramuskulær
English: Amoxil Syrup SucroseFree /Dye-Free 250mg/5ml
Danish: Amoxil Syrup Sucrose-Free /DyeFree 250mg/5ml
English: Intravenous
Danish: Intravenøs
English: Intramuscular
Danish: Intramuskulær
English: Powder for oral suspension (sachet)
Danish: Pulver til oral suspension (brev)
English: Clamoxyl 1g comprimidos 1 g
Danish: Clamoxyl 1g comprimidos
English: 500 mg Capsule, hard
Danish: 500 mg Kapsel, hård
English: 500 mg Capsule
Danish: 500 mg Kapsel
English: Stonemasons Way Rathfarnham Dublin 16
Danish: GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham
English: Amoxil Vials for Injection 1 g
Danish: Amoxil Vials for Injection
English: Amoxil Capsules 500mg 500 mg Capsule
Danish: Amoxil Capsules 500mg
English: Amoxicilline Biogaran 1 g
Danish: Amoxicilline Biogaran
English: Amoxil 500 mg kapsulas 500 mg Capsule
Danish: Amoxil 500 mg kapsulas
English: Powder for solution for injection
Danish: Pulver til injektionsvæske, opløsning
English: Clamoxyl 500 mg polvo para suspensión oral en sobre
Danish: 500 mg Pulver til oral suspension
English: Clamoxyl 250 mg/ 5 ml polvo para suspensión oral en frasco
Danish: 5 ml polvo para suspensión oral en frasco
English: United Kingdom250 mg Capsule
Danish: 250 mg Kapsel
English: Date of first authorisation: 10 March 2004 Date of latest renewal: 12 March 2009
Danish: Dato for første markedsføringstilladelse: 10. marts 2004 Dato for seneste fornyelse: 12. marts 2009
English: Apo B decreased by 12%.
Danish: Apo-B faldt med 12%.
English: The safety and efficacy in children (below the age of 18 years) has not been studied.
Danish: Sikkerheden og virkningen hos børn (under 18 år) er ikke blevet undersøgt.
English: Very rare: Pancreatitis
Danish: Meget sjælden: Pancreatitis
English: If necessary, your doctor may advise you to take vitamin supplements.
Danish: Om nødvendigt kan Deres læge råde Dem til at tage vitamintilskud.
English: Other forms of interaction
Danish: Andre former for interaktion
English: Your doctor may stop your medicine.
Danish: Deres læge vil måske afbryde Deres medicinering.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Indberetningshyppigheden klassificeres som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndendeværende data).
English: You may take your dose with a later meal, but never take in one day more than the total number of tablets that your doctor has prescribed to you in a single day.
Danish: De kan tage Deres dosis sammen med et senere måltid, men De må aldrig på én dag tage mere end det samlede antal tabletter, som Deres læge har ordineret til Dem.
English: Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested.
Danish: Doser på over den maksimale anbefalede dosis (4,5 g pr. dag [7 tabletter]) er ikke afprøvet.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle label after “EXP''
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter “EXP”.
English: Cholestagel may affect the way in which the following medicines work:
Danish: Cholestagel kan påvirke den måde, som følgende lægemidler virker på:
English: When administering medicinal products for which alterations in blood levels could have a clinically significant effect on safety or efficacy, physicians should consider monitoring serum levels or effects.
Danish: Ved indtagelse af lægemidler, for hvilke ændringer i blodniveauer kan have en klinisk signifikant indflydelse på sikkerhed eller effekt, bør lægerne overveje at overvåge serumniveauer eller -virkninger.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached..
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.