FrancophonIA/ELRC3.0 huggingface dataset:
English: It should be used with caution in patients over 65 years of age, with frequent monitoring of blood counts, the liver and the kidneys.
Danish: Det bør anvendes med forsigtighed hos patienter over 65 år, med hyppig overvågning af blodtal og lever- og nyrefunktion.
English: Why has Litak been approved?
Danish: Hvorfor blev Litak godkendt?
English: Litak has been examined in one main study involving 63 adults with hairy cell leukaemia.
Danish: Litak er blevet undersøgt i én hovedundersøgelse, hvor i alt 63 voksne med hårcelleleukæmi deltog.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Litak is available here.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme vedrørende Litak findes her.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Litak's benefits are greater than its risks for the treatment of hairy cell leukaemia.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Litak opvejer risiciene til behandling af hårcelleleukæmi.
English: Purine is one of the fundamental chemicals that make up DNA.
Danish: Purin er et af de grundlæggende kemiske stoffer, som dna består af.
English: Because the number of patients with hairy cell leukaemia is low, the disease is considered ‘rare', and Litak was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 September 2001.
Danish: Da der kun findes et lille antal patienter med hårcelleleukæmi, anses sygdommen for at være sjælden, og Litak blev udpeget som lægemiddel til sjældne sygdomme den 18. september 2001.
English: Litak must not be used during pregnancy or breast-feeding, in patients less than 18 years of age, in patients with moderate to severe kidney or liver disease or in combination with other medicines that reduce the production of blood cells.
Danish: Litak må heller ikke anvendes til behandling af gravide eller ammende kvinder, patienter under 18 år, patienter med moderat til svær lever- eller nyresygdom eller i en kombination med andre lægemidler, der nedsætter produktionen af blodlegemer.
English: The term ‘hairy cell' refers to the hair-like projections that can be seen on the surface of the lymphocytes when they are examined under a microscope.
Danish: Begrebet 'hårcelle' anvendes, fordi der ses nogle hårlignende pigge på overfladen af lymfocytterne, når de betragtes med mikroskop.
English: What is Litak?
Danish: Hvad er Litak?
English: The active substance in Litak, cladribine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Danish: Det aktive stof i Litak, cladribin, er en cellegift, dvs. et lægemiddel, der dræber celler, der deler sig, f.eks. kræftcellerne.
English: This prevents the cells from dividing, slowing down the progression of leukaemia.
Danish: Dermed forhindres cellerne i at dele sig, og leukæmien udvikler sig som følge deraf langsommere.
English: In the body, cladribine is converted within lymphocytes into a chemical called CdATP, which interferes with the production of new DNA.
Danish: I kroppen omdannes Cladribin i lymfocytterne til et kemisk stof kaldet CdATP, der forstyrrer produktionen af ny dna.
English: Patients can inject themselves once they have been trained appropriately.
Danish: Patienterne kan efter grundig oplæring selv foretage injektionen.
English: Litak must not be given to patients with moderate to severe liver or kidney disease.
Danish: Litak må ikke gives til patienter med moderat til svær lever- eller nyresygdom.
English: Cladribine is an ‘analogue' of purine (a substance that has a similar chemical structure to purine).
Danish: Cladribin er en purinanalog (et stof, der har en kemisk struktur svarende til purin).
English: Litak is a solution for injection that contains the active substance cladribine.
Danish: Litak er en opløsning til injektion, der indeholder det aktive stof cladribin.
English: What benefit has Litak shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Litak?
English: What is Litak used for?
Danish: Hvad anvendes Litak til?
English: For the full list of all side effects reported with Litak, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Litak fremgår af indlægssedlen.
English: How has Litak been studied?
Danish: Hvordan blev Litak undersøgt?
English: How is Litak used?
Danish: Hvordan anvendes Litak?
English: Litak is used to treat adults with hairy cell leukaemia, a cancer of blood in which too many B-lymphocytes (a type of white blood cell) are produced.
Danish: Det er en form for kræft i blodet, hvor der produceres for mange af den type hvide blodlegemer, der hedder B-lymfocytter.
English: Litak should not be used in people who may be hypersensitive (allergic) to cladribine or any of the other ingredients.
Danish: Patienter, der kan være overfølsomme (allergiske) over for cladribin eller andre af indholdsstofferne, bør ikke anvende Litak.
English: How does Litak work?
Danish: Hvordan virker Litak?
English: With respect to quality aspects,
Danish: Hvad angår kvalitetsaspekter:
English: The procedure started on 29 March 2007.
Danish: Proceduren blev indledt den 29. marts 2007.
English: The Marketing Authorisation Holder provided supplementary information on 16 October 2007.
Danish: Indehaveren af markedsføringstilladelsen fremlagde supplerende oplysninger den 16. oktober 2007.
English: London, 23 July 2008 Doc.
Danish: London, den 23. juli 2008 Ref. dok.
English: A Decision was issued by the European Commission on 23 July 2008.
Danish: Europa-Kommissionen vedtog en afgørelse den 23. juli 2008.
English: Adults and children above 12 years
Danish: Voksne og børn over 12 år
English: Bipolar disorder
Danish: Bipolar sygdom
English: The drug substance and the drug product have been appropriately described and generally satisfactory documentation has been provided.
Danish: Lægemiddelstoffet og lægemidlet er udførligt beskrevet, og der er fremlagt generelt tilfredsstillende dokumentation.
English: Children 2 to 12 years
Danish: Børn fra 2 til 12 år
English: Ref. EMEA/CHMP/212114/2008
Danish: EMEA/476652/2008
English: Lamictal and associated names, 25 mg, 50 mg, 100 mg, 200 mg tablet and 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg, dispersible / chewable tablet, is an antiepileptic drug, used for the treatment of epilepsy and Bipolar Disorder.
Danish: Lamictal og tilknyttede navne, leveret som tabletter på 25 mg, 50 mg, 100 mg og 200 mg og dispergible tabletter/tyggetabletter på 2 mg, 5 mg, 25 mg, 50 mg, 100 mg og 200 mg, er et antiepileptikum, der anvendes til behandling af epilepsi og bipolar sygdom.
English: The excipients used in the formulations of the drug product and manufacturing processes are standard for the proposed pharmaceutical forms.
Danish: De hjælpestoffer, der er anvendt i formuleringen af lægemidlet, og fremstillingsprocesserne er standard for de foreslåede lægemiddelformer.
English: The results indicate that the drug substance and drug product can be reproducibly manufactured.
Danish: Resultaterne viser, at lægemiddelstoffet og lægemidlet kan reproduceres.
English: Adults 18 years and above
Danish: Voksne over 18 år
English: Lamictal is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes.
Danish: Lamictal er indiceret til forebyggelse af humørsvingninger hos patienter med bipolar sygdom, fortrinsvis forebyggelse af depressive episoder.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Lamictal and associated names approved across EU Member States, with respect to the indication,
Danish: Begrundelsen for indbringelsen var, at der er forskelle mellem medlemsstaternes produktresuméer, herunder kvalitetsaspekter, for Lamictal og tilknyttede navne, som er godkendt i EU-medlemsstaterne, hvad angår indikationerne:
English: On 1 March 2007, GlaxoSmithKline Research & Development Limited presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Lamictal and associated names.
Danish: Den 1. marts 2007 indbragte GlaxoSmithKline Research & Development Limited en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF med senere ændringer for at harmonisere produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekter, der er godkendt i medlemsstaterne, for lægemidlet Lamictal og tilknyttede navne.
English: During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Danish: På mødet den 21.-24. april 2008 fandt Udvalget for Humanmedicinske lægemidler i lyset af alle de foreliggende data og faglige drøftelser i udvalget, at forslaget om harmonisering af produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekter, var acceptabelt, og at ændringerne burde foretages.
English: After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on Lamictal monotherapy.
Danish: Efter opnåelse af kontrol over de epileptiske anfald ved hjælp af tillægsbehandlingen kan behandling med ledsagende antiepileptiske lægemidler ophøre, og patienterne kan fortsætte med Lamictal som monoterapi.
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Lamictal and associated names.
Danish: Udvalget for Humanmedicinske Lægemidler afgav den 24. april 2008 en positiv udtalelse, hvori udvalget henstillede til harmonisering af produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekter, for Lamictal og tilknyttede navne.
English: Lamictal is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.
Danish: Lamictal er indiceret til anvendelse som tillægsbehandling eller monoterapi ved behandling af epilepsi med partielle og/eller generaliserede anfald, herunder tonisk-kloniske kramper og anfald forbundet med Lennox-Gastaut syndrom.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Danish: De faglige konklusioner fremgår af bilag II, og bilag III indeholder ændringerne til produktresumé, etikettering og indlægsseddel.
English: Lamictal is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.
Danish: Lamictal er indiceret til anvendelse som tillægsbehandling ved behandling af epilepsi med partielle og generaliserede anfald, herunder tonisk-kloniske kramper og anfald forbundet med Lennox-Gastaut syndrom.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Lamictal and associated names International Non-Proprietary Name (INN): lamotrigine
Danish: Internationalt fællesnavn (INN): lamotrigin
English: This overview was last updated in December 2018.
Danish: Denne oversigt blev sidst ajourført i december 2018.
English: Evant received a marketing authorisation valid throughout the EU on 5 February 2019.
Danish: Evant fik en markedsføringstilladelse med gyldighed i hele EU den 5. februar 2019.
English: Evant is a vaccine.
Danish: Evant er en vaccine.
English: Other information about Evant
Danish: Andre oplysninger om Evant
English: Protection starts at 2 weeks after vaccination and lasts until 9 weeks after vaccination.
Danish: Beskyttelsen begynder 2 uger efter vaccinationen og varer indtil 9 uger efter vaccinationen.
English: The withdrawal period for meat and eggs from chickens treated with Evant is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og æg fra kyllinger, der behandles med Evant, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The vaccine is given to chicks from one day old.
Danish: Vaccinen gives til kyllinger fra de er én dag gamle.
English: Further information on Evant can be found on the Agency's website: ema.europa.eu/Find medicine/veterinary/EPAR/evant.
Danish: Yderligere information om Evant findes på agenturets websted under: ema.europa.eu/Find medicine/veterinary/EPAR/evant.
English: Evant (avian coccidiosis vaccine, live)
Danish: Evant (aviær coccidiosevaccine, levende)
English: These studies had a control group of chicks that received a dummy vaccination.
Danish: Disse studier havde en kontrolgruppe af kyllinger, som fik en uvirksom vaccination.
English: The European Medicines Agency decided that Evant's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Evant opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The birds ingest the vaccine when preening their feathers.
Danish: Fuglene indtager vaccinen, når de pudser deres fjer.
English: An overview of Evant and why it is authorised in the EU
Danish: En oversigt over Evant, og hvorfor det er godkendt i EU
English: In the future if the animals are exposed to the same Eimeria species the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for samme Eimeria-art, vil immunsystemet være i stand til at reagere hurtigere.
English: What is Evant and what is it used for?
Danish: Hvad er Evant, og hvad anvendes det til?
English: There are no known side effects with Evant.
Danish: Der er ingen kendte bivirkninger ved Evant.
English: Evant (avian coccidiosis vaccine, live) EMA/893808/2018
Danish: Evant (aviær coccidiosevaccine, levende) EMA/893808/2018
English: The vaccine suspension should be diluted with the solvent and water according to dosing instructions and sprayed on the birds so that each bird receives one dose.
Danish: Vaccinesuspensionen fortyndes med solvensen og vand ifølge doseringsanvisningerne og sprayes på fuglene, så hver fugl får én dosis.
English: The vaccine solvent contains the adjuvant montanide IMS to enhance the immune response.
Danish: Vaccinens solvens indeholder adjuvanset montanide IMS for at styrke immunreaktionen.
English: The vaccine contains the oocysts of Eimeria species that have been weakened so that they cannot cause disease.
Danish: Vaccinen indeholder oocyster af Eimeria-arter, som er blevet svækket, så de ikke kan fremkalde sygdom.
English: Evant is available as a suspension and solvent and can only be obtained with a prescription.
Danish: Evant fås som en suspension og en opløsning og udleveres kun efter recept.
English: Laboratory studies have shown that 1-day-old chicks vaccinated with Evant were protected against coccidiosis when exposed to each of the five Eimeria species at 2 weeks after vaccination and protection lasted 9 weeks after vaccination.
Danish: Laboratoriestudier har vist, at 1 dag gamle kyllinger, der er vaccineret med Evant, er beskyttet mod coccidiose, når de eksponeres for hver af de fem Eimeria-arter 2 uger efter vaccinationen, og beskyttelsen varede i 9 uger efter vaccinationen.
English: What are the risks associated with Evant?
Danish: Hvilke risici er der forbundet med Evant?
English: Why is Evant authorised in the EU?
Danish: Hvorfor blev Evant godkendt i EU?
English: When Evant is given to chickens, the animals' immune system recognises the Eimeria oocysts as foreign and makes defences against them.
Danish: Når Evant gives til kyllinger, registrerer dyrenes immunsystem Eimeria-oocysterne som fremmede og danner et forsvar mod dem.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Evant, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Evant, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: For more information about using Evant, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Evant, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: How is Evant used?
Danish: Hvordan anvendes Evant?
English: What benefits of Evant have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Evant?
English: The vaccine contains live attenuated (weakened) oocysts of Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Danish: Vaccinen indeholder levende, svækkede oocyster af Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox og Eimeria tenella.
English: The studies showed Evant reduced damage to the gut and oocysts in the faeces for each Eimeria species and that it reduced diarrhoea caused by Emeria acervulina, Eimeria maxima and Eimeria tenella.
Danish: Studierne viste, at Evant mindskede beskadigelsen af tarmene og mængden af oocyster i fæces for hver Eimeria-art, og at det reducerede diarré forårsaget af Eimeria acervulina, Eimeria maxima og Eimeria tenella.
English: Evant is a veterinary vaccine used to protect chickens against coccidiosis caused by the coccidia parasites Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Danish: Evant er en vaccine til at beskytte kyllinger mod coccidiose forårsaget af coccidiaparasitterne Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox og Eimeria tenella.
English: How does Evant work?
Danish: Hvordan virker Evant?
English: This is a summary of the European public assessment report (EPAR) for Truberzi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Truberzi.
English: The full EPAR for Truberzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Truberzi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 100 mg with food each morning and evening.
Danish: Den anbefalede dosis er 100 mg sammen med mad hver morgen og aften.
English: Other information about Truberzi
Danish: Andre oplysninger om Truberzi
English: In patients who get troublesome side effects, the dose can be reduced to 75 mg each morning and evening.
Danish: Hos patienter, der får generende bivirkninger, kan dosen nedsættes til 75 mg hver morgen og aften.
English: Side effects were mainly limited to the digestive system and mostly mild.
Danish: Bivirkningerne er hovedsageligt begrænset til fordøjelsessystemet og er for det meste milde.
English: What measures are being taken to ensure the safe and effective use of Truberzi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Truberzi?
English: The Committee therefore decided that Truberzi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Udvalget konkluderede derfor, at fordelene ved Truberzi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This causes food to remain in the gut for longer, increasing the absorption of fluids and so reducing diarrhoea.
Danish: Dermed bliver maden i tarmen i længere tid, og det øger optagelsen af væsker og reducerer dermed diarré.
English: Effectiveness was measured as an improvement of over 30% in abdominal pain combined with an absence of very loose stool.
Danish: Virkningen blev defineret som en forbedring på mere end 30 % med hensyn til mavesmerter kombineret med fravær af meget løs afføring.
English: It is available as tablets containing 75 mg and 100 mg eluxadoline.
Danish: Det fås som tabletter med 75 og 100 mg eluxadolin.
English: Why is Truberzi approved?
Danish: Hvorfor blev Truberzi godkendt?
English: Truberzi can only be obtained with a prescription.
Danish: Truberzi udleveres kun efter recept.
English: Truberzi eluxadoline
Danish: Truberzi eluxadolin
English: It is not intended to provide practical advice on how to use Truberzi.
Danish: Det er ikke en praktisk vejledning i, hvordan Truberzi bør anvendes.
English: What is Truberzi and what is it used for?
Danish: Hvad er Truberzi, og hvad anvendes det til?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Truberzi are modest but there is an unmet need for treatments of irritable bowel syndrome with diarrhoea.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) er af den opfattelse, at fordelene ved Truberzi er beskedne, men at der er et udækket behov for at behandle irritabel tyktarm med diarré.
English: Truberzi must not be given to patients treated with a class of medicines known as potent OATP1B1 inhibitors (such as ciclosporin, a medicine that works on the immune system).
Danish: Truberzi må ikke gives til patienter, der er i behandling med lægemidler, der kaldes potente OATP1B1hæmmere (f.eks. cyclosporin, et lægemiddel, der virker på immunsystemet).
English: What are the risks associated with Truberzi?
Danish: Hvilke risici er der forbundet med Truberzi?
English: Eluxadoline, the active substance in Truberzi, is an opioid receptor agonist.
Danish: Eluxadolin, det aktive stof i Truberzi, er en opioidreceptor-agonist.
English: Because eluxadoline is not absorbed into the blood and distributed around the body, its effects are largely confined to the gut.
Danish: Da eluxadolin ikke optages i blodet og fordeles rundt i kroppen, virker det stort set kun i tarmsystemet.
English: Truberzi must not be given to patients with liver disorders, those at risk of pancreatitis (such as those who have had problems with their pancreas or who drink alcohol excessively), patients whose gall bladders have been removed or who have disorders affecting secretion of bile into the gut, and those who have had severe or long-term constipation or blocked bowel.
Danish: Truberzi må ikke gives til patienter med leversygdomme, eller som har risiko for at udvikle pancreatitis (f.eks. patienter, der har haft problemer med bugspytkirtlen, eller som drikker for meget alkohol), patienter, hvis galdeblære er blevet fjernet, eller som har lidelser, der påvirker udskillelsen af galde i tarmen, og patienter, som har haft alvorlig eller langvarig forstoppelse eller blokeret tarmsystem.
English: For more information about treatment with Truberzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Truberzi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is used for the treatment of adults who have irritable bowel syndrome with diarrhoea.
Danish: Det anvendes til at behandle voksne, der lider af irritabel tyktarm med diarré.
English: Truberzi was evaluated in two main studies involving over 2,400 patients with irritable bowel syndrome with diarrhoea.
Danish: Truberzi blev vurderet i to hovedundersøgelser med over 2 400 patienter med irritabel tyktarm med diarré.
English: The most common side effects with Truberzi (which may affect more than 5 in 100 people) are constipation, nausea (feeling sick) and abdominal pain.
Danish: De hyppigste bivirkninger ved Truberzi (som kan forekomme hos mere end 5 ud af 100 personer) er forstoppelse, kvalme og mavesmerter.