FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets should be swallowed whole with some liquid, and not chewed, divided or crushed.
Danish: Hos patienter, der har større behov for afhjælpning af symptomerne, kan dosis øges til 15 mg. Tabletterne skal sluges hele med væske og må ikke tygges, deles eller knuses.
English: How is Emselex used?
Danish: Hvordan anvendes Emselex?
English: How does Emselex work?
Danish: Hvordan virker Emselex?
English: EMA/32301/2010 EMEA/H/C/1221
Danish: 20. januar 2010 EMA/393204/2010 EMEA/H/C/1221
English: The main measures of effectiveness were the reduction in the average number of seizures every month and the number of patients who had their monthly number of seizures reduced by at least a half.
Danish: Det primære mål for effekt var nedbringelsen af det gennemsnitlige antal anfald hver måned og antallet af patienter, som fik deres månedlige antal anfald reduceret til mindst halvdelen.
English: The company also presented data from three main studies involving 1,664 patients with partial-onset seizures who were already treated with up to three other anti-epileptic medicines.
Danish: Virksomheden fremlagde også data fra tre hovedundersøgelser, som omfattede 1 664 patienter med partielle anfald, der allerede var blevet behandlet med op til tre andre antiepileptika.
English: The effects of Comfyde were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Comfyde blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The letter from the company notifying the Agency of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori agenturet underrettes om tilbagetrækning af ansøgningen, findes her.
English: As this is being done, other medicines the patients are receiving for epilepsy may be adjusted as needed.
Danish: Efterhånden som dette gøres, kan andre lægemidler, som patienterne får mod epilepsi, tilpasses efter behov.
English: What is Comfyde?
Danish: Hvad er Comfyde?
English: Comfyde was expected to be used to treat patients aged 16 years and above.
Danish: Comfyde forventedes anvendt til behandling af patienter på 16 år og derover.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Danish: Det en form for epilepsi, hvor for stærk elektrisk aktivitet i en side af hjernen giver symptomer som pludselige, sætvise bevægelser af en del af kroppen, forvrænget hørelse, lugt- eller synshallucinationer, følelsesløshed eller pludselig angst.
English: On 15 January 2010, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Comfyde, for use in the treatment of partial-onset seizures in patients with epilepsy.
Danish: Den 15. januar 2010 meddelte Janssen-Cilag International NV officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Comfyde til behandling af partielle anfald hos patienter med epilepsi.
English: The patients added either Comfyde or placebo (a dummy treatment) to their existing treatment.
Danish: Patienterne fik enten tilføjet Comfyde eller placebo (en virkningsløs behandling) til deres eksisterende behandling.
English: Comfyde is a medicine that contains the active substance carisbamate.
Danish: Comfyde er et lægemiddel, der indeholder det aktive stof carisbamat.
English: Withdrawal of the marketing authorisation application for Comfyde (carisbamate)
Danish: Tilbagetrækning af ansøgning om markedsføringstilladelse for Comfyde (carisbamat)
English: By reducing the activity of sodium channels and through its other possible actions, carisbamate was expected to prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit happening.
Danish: Ved at reducere natriumkanalernes aktivitet og via sine potentielle andre virkninger forventedes carisbamat at forhindre den abnorme elektriske aktivitet i at sprede sig til hele hjernen, hvorved muligheden for at få et epileptisk anfald mindskedes.
English: Withdrawal of the marketing authorisation application for Comfyde (carisbamate) EMA/32301/2010
Danish: Tilbagetrækning af ansøgning om markedsføringstilladelse for Comfyde (carisbamat) EMA/393204/2010
English: Comfyde was expected to be used as an add-on to existing treatments for partial-onset seizures (fits) with or without secondary generalisation in patients with epilepsy.
Danish: Comfyde forventedes anvendt som tillægsbehandling til eksisterende behandlinger for partielle anfald med eller uden sekundær generalisering hos patienter med epilepsi.
English: The active substance in Comfyde, carisbamate, is an anti-epileptic medicine.
Danish: Det aktive stof i Comfyde, carisbamat, er et antiepileptikum.
English: The exact way in which carisbamate works in the body is not known, but some of its activity might be explained by the blocking of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Danish: Det vides ikke med nøjagtighed, hvordan carisbamat virker i kroppen, men en del af dets virkning kan forklares ved, at det blokerer natriumkanalerne (porer på nervecellernes overflade), som er dem, der muliggør overførslen af elektriske impulser mellem nerveceller.
English: How is Comfyde expected to work?
Danish: Hvordan forventes Comfyde at virke?
English: What was Comfyde expected to be used for?
Danish: Hvad forventedes Comfyde anvendt til?
English: What are the consequences for patients in clinical trials or compassionate use programmes with Comfyde?
Danish: Hvad er konsekvenserne for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse?
English: The company has informed the CHMP that patients in epilepsy clinical trials will have their Comfyde treatment discontinued gradually.
Danish: Virksomheden har underrettet CHMP om, at behandlingen af patienter i kliniske epilepsiundersøgelser med Comfyde nedtrappes gradvist.
English: ATCvet code: QI04AA02.
Danish: ATCvet-kode: QI04AA02.
English: Date of first authorisation:09/01/2019
Danish: Dato for første markedsføringstilladelse: 09/01/2019
English: The number and type(s) of strains included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.
Danish: Antallet og typen/typerne af stammer, der indgår i det færdige produkt, vil blive tilpasset til den aktuelle epidemiologiske situation på tidspunktet for formuleringen af det færdige produkt og vil blive vist på etiketten.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af denne markedsføringstilladelse skal underrette Europa-Kommissionen om markedsføringsplanerne for det lægemiddel, der er godkendt ved denne beslutning.
English: The development of local reactions is very common at the site of injection after vaccination.
Danish: Udvikling af lokale reaktioner på injektionsstedet efter vaccinering er meget almindeligt.
English: *Below the level of detection by the validated RT-PCR method at 1.32 log10 TCID50/ml
Danish: * Under detektionsniveauet for den validerede RT-PCR-metode ved 1,32 log10 TCID50/ml
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Danish: Effekten hos andre arter kan være forskellig fra den, der er observeret hos får og kvæg.
English: People with known hypersensitivity to aluminium hydroxide, thiomersal or saponins should avoid contact with the veterinary medicinal product.
Danish: Ved overfølsomhed over for aluminiumhydroxid, thiomersal eller saponiner bør kontakt med veterinærlægemidlet undgås.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Danish: Anvendelsen af dette veterinærlægemiddel er kun tilladt under særlige betingelser, som er fastsat i EU's lovgivning vedrørende kontrol med bluetonguevirus.
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Danish: Hvis lægemidlet anvendes hos andre drøvtyggende husdyr eller vilde arter, der anses for at have risiko for at blive smittet, bør behandlingen af disse dyr ske med forsigtighed, og det er tilrådeligt at teste vaccinen på et mindre antal dyr før massevaccination.
English: * Relative potency compared to a reference vaccine.
Danish: * Relativ styrke i forhold til en referencevaccine.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or National Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Danish: I denne kategori af dyr bør vaccinen kun anvendes i overensstemmelse med den ansvarlige dyrlæges og/eller de nationale kompetente myndigheders vurdering af benefit/risk-forholdet i forhold til den gældende vaccinationspolitik mod bluetonguevirus.
English: Adjuvants: Aluminium hydroxide (Al
Danish: Adjuvanser: Aluminiumhydroxid (Al
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Withdrawal period: zero days.
Danish: Tilbageholdelsestid: nul dage.
English: Pharmacotherapeutic group: Inactivated bluetongue virus vaccines for sheep.
Danish: Farmakoterapeutisk gruppe: Inaktiverede bluetonguevirus vacciner til får.
English: * Maximum of two different inactivated bluetongue virus serotypes:
Danish: * Højst to forskellige inaktiverede bluetonguevirus-serotyper:
English: A transient increase in rectal temperature, not exceeding 2.3 °C, during the 48 hours following vaccination, is very common.
Danish: En forbigående stigning i rektalt målt kropstemperatur på højst 2,3 °C i løbet af de første 48 timer efter vaccination er meget almindelig.
English: Active substances*:
Danish: Aktive stoffer*:
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State´s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende dette veterinære lægemiddel, skal forinden rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik, da disse aktiviteter kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til den nationale lovgivning.
English: Shelf life after first opening the immediate packaging: 10 hours.
Danish: Opbevaringstid efter første åbning af den indre emballage: 10 timer.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Danish: Interaktion med andre lægemidler og andre former for interaktion
English: Syvazul BTV suspension for injection for sheep and cattle
Danish: Syvazul BTV injektionsvæske, suspension, til får og kvæg
English: - Reproductive system disorders: abortion, perinatal mortality or premature parturition - Systemic disorders: apathy, recumbency, fever, anorexia or lethargy.
Danish: - Det reproduktive system: abort, perinatal mortalitet eller præmatur fødsel - Systemiske sygdomme: apati, tilbøjelighed til at blive liggende, feber, anoreksi eller letargi.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen refererer til den sidste dag i den nævnte måned.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Det aktive stof, som principielt er af biologisk oprindelse, og hvis formål er at producere aktiv immunitet, falder ikke inden for anvendelsesområdet af forordning (EF) nr. 470/2009, når det anvendes som i dette veterinærlægemiddel.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Danish: Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
English: No information is available on the use of the vaccine containing BTV4 serotype in cattle with maternally-derived antibodies.
Danish: Der er ingen tilgængelige oplysninger vedrørende anvendelse af vaccinen med BTV4-serotype hos kvæg med maternelt afledte antistoffer.
English: A painless nodule that may reach up to 3.8 cm diameter in sheep and 7 cm diameter in cattle develops very commonly after 2 to 6 days and diminishes progressively over time.
Danish: En smertefri knude, der kan blive op til 3,8 cm i diameter hos får og 7 cm hos kvæg, er meget almindelig efter 2-6 dage; den forsvinder igen over tid.
English: The following might be observed on rare occasions in sheep and on very rare occasions in cattle:
Danish: Følgende kan i sjældne tilfælde ses hos får og i meget sjældne tilfælde hos kvæg:
English: The following might be observed on very rare occasions in sheep and cattle:
Danish: Følgende kan i meget sjældne tilfælde observeres hos får og kvæg:
English: Inactivated bluetongue virus (BTV)
Danish: Inaktiveret bluetonguevirus (BTV)
English: Store and transport refrigerated (2 C - 8 C).
Danish: Opbevares og transporteres nedkølet (2 C-8 C).
English: Store and transport refrigerated (2 ºC - 8 ºC).
Danish: Opbevares og transporteres nedkølet (2-8 ºC).
English: After administration of a double dose, no other adverse reactions different to those mentioned in ‘ADVERSE REACTIONS' were observed.
Danish: Der er efter administration af en dobbelt dosis ikke set andre bivirkninger end dem, der er nævnt under "BIVIRKNINGER".
English: EXP {month/year} Once broached use within 10 hours.
Danish: EXP {måned/år} Skal anvendes inden for 10 timer efter åbning.
English: Silicon antifoaming agent Water for injections
Danish: Silikoneholdigt antiskummiddel Vand til injektionsvæsker
English: Administer subcutaneously to sheep from 3 months of age, according to the following scheme:
Danish: Administreres subkutant hos får fra 3-måneders alderen i henhold til følgende plan:
English: Cattle: Intramuscular use.
Danish: Kvæg: Intramuskulær anvendelse.
English: Duration of immunity: one year after completion of the primary vaccination scheme.
Danish: Varighed af immunitet: et år efter gennemførelse af den primære vaccinationsplan.
English: Erythema associated with mild to moderate oedema is very common from 1 to 6 days after the administration.
Danish: Erytem forbundet med let til moderat ødem er meget almindeligt 1-6 dage efter indgivelsen.
English: No information is available on the use of the vaccine in sheep with maternally-derived antibodies.
Danish: Der er ingen tilgængelige oplysninger vedrørende anvendelse af vaccinen hos får med maternelt afledte antistoffer.
English: Pinkish-white suspension for injection easily homogenised by shaking.
Danish: Lyserødlig-hvid suspension til injektion, der nemt homogeniseres ved omrystning.
English: Pinkish-white suspension easily homogenised by shaking.
Danish: Lyserødlig-hvid suspension, der nemt homogeniseres ved omrystning.
English: Polypropylene colourless vial containing 80 ml or 200 ml, with a type I bromobutyl rubber stopper, sealed with an aluminium closure.
Danish: Farveløst hætteglas af polypropylen indeholdende 80 ml eller 200 ml med en type 1bromobutylgummiprop og aluminiumsforsegling.
English: Semi-purified saponin from Quillaja saponaria
Danish: Delvist renset saponin fra Quillaja saponaria
English: ** Relative potency measured by ELISA in relation to a reference vaccine whose efficacy has been demonstrated by challenge in the target species.
Danish: ** Relativ styrke målt ved hjælp af ELISA i forhold til en referencevaccine, hvis effekt er blevet påvist ved eksponering hos målarterne.
English: Semi-purified saponin from Quillaja saponaria Thiomersal
Danish: Delvist renset saponin fra Quillaja saponaria Thiomersal
English: - Reduction in milk production - Neurological disorders: paralysis, ataxia, blindness or incoordination - Respiratory tract disorders: pulmonary congestion, dyspnoea - Digestive tract disorders: rumen atony or bloating - Hypersensitivity reactions: with hypersalivation - Death.
Danish: - Fald i mælkeproduktion - Nervesystemet: paralyse, ataksi, blindhed eller manglende koordination - Luftvejene: lungestase, dyspnø - Fordøjelseskanalen: vom-atoni eller oppustethed - Overfølsomhedsreaktioner: øget spytproduktion - Dødsfald.
English: Sheep: Subcutaneous use.
Danish: Får: Subkutan anvendelse.
English: * Relative potency measured by ELISA in relation to a reference vaccine whose efficacy has been demonstrated by challenge in the target species.
Danish: * Relativ styrke målt ved hjælp af ELISA i forhold til en referencevaccine, hvis effekt er blevet påvist ved eksponering hos målarterne.
English: Onset of immunity: 39 days after completion of the primary vaccination scheme.
Danish: Indtræden af immunitet: 39 dage efter gennemførelse af den primære vaccinationsplan.
English: Administer intramuscularly to cattle from 2 months of age in naïve animals or from 3 months of age in calves born to immune cattle, according to the following scheme:
Danish: Administreres intramuskulært hos kvæg fra 2-måneders alderen (naive dyr) eller fra 3-måneders alderen (kalve af immune dyr) i henhold til følgende plan:
English: 4.7 Use during pregnancy, lactation or lay
Danish: Anvendelse under drægtighed, laktation eller æglægning
English: 6.2 Major incompatibilities
Danish: Væsentlige uforligeligheder
English: Onset of immunity: 21 days after completion of the primary vaccination scheme.
Danish: Indtræden af immunitet: 21 dage efter gennemførelse af den primære vaccinationsplan.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate anhydrous Sodium chloride
Danish: Kaliumdihydrogenfosfat Dinatriumhydrogenfosfat, vandfri Natriumchlorid
English: Most local reactions disappear or become residual (≤ 1cm) before 70 days in sheep and 30 days in cattle, although residual nodules can persist after that time.
Danish: De fleste lokale reaktioner forsvinder eller bliver meget små (≤ 1cm) i løbet af 70 dage hos får og 30 dage hos kvæg, idet meget små knuder dog kan vare ved efter denne tid.
English: After administration of a double dose, no other adverse reactions different to those mentioned in section 4.6 were observed.
Danish: Der er efter indgivelse af en dobbelt dosis ikke set andre bivirkninger end dem, der er nævnt i pkt.
English: Most local reactions disappear or become residual (≤ 1 cm) before 70 days in sheep and 30 days in cattle, although residual nodules can persist after that time.
Danish: De fleste lokale reaktioner forsvinder eller bliver meget små (≤ 1 cm) i løbet af 70 dage hos får og 30 dage hos kvæg, idet meget små knuder dog kan vare ved efter denne tid.
English: 4.6 Adverse reactions (frequency and seriousness)
Danish: Bivirkninger (forekomst og sværhedsgrad)
English: An abscess may appear on rare occasions.
Danish: I sjældne tilfælde ses en absces.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Danish: Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: - Primary vaccination: administer a single 2 ml dose
Danish: - Primær vaccination: Indgiv en enkelt dosis på 2 ml
English: To stimulate active immunity of sheep and cattle against bluetongue virus serotypes 1, 4 and/ or 8 related to those contained in the vaccine (combination of maximum 2 serotypes).
Danish: Til stimulering af aktiv immunitet hos får og kvæg mod bluetonguevirus serotype 1, 4 og/eller 8 relateret til de serotyper, der er indeholdt i vaccinen (kombination af højst 2 serotyper).
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Danish: Sikkerheden og virkningen af vaccinen er ikke klarlagt hos væddere og tyre, der er beregnet til avl.
English: Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1
Danish: Inaktiveret bluetonguevirus, serotype 1 (BTV-1), stamme ALG2006/01 E1
English: 6.5 Nature and composition of immediate packaging
Danish: Den indre emballages art og indhold
English: - Revaccination: administer one dose of 2 ml after 12 months.
Danish: - Revaccination: Indgiv en enkelt dosis på 2 ml efter 12 måneder.
English: - Revaccination: administer one dose of 4 ml after 12 months.
Danish: - Revaccination: Indgiv en enkelt dosis på 4 ml efter 12 måneder.
English: Cardboard box with 1 vial containing 200 ml.
Danish: Kartonæske med 1 hætteglas med 200 ml.
English: Cardboard box with 1 vial containing 80 ml.
Danish: Kartonæske med 1 hætteglas med 80 ml.
English: Box of 1 vial of 80 ml Box of 1 vial of 200 ml
Danish: Æske med 1 hætteglas a 80 ml Æske med 1 hætteglas a 200 ml
English: - Primary vaccination: administer two doses of 4 ml 3 weeks apart.
Danish: - Primær vaccination: Indgiv to doser på 4 ml med tre ugers mellemrum.
English: For active immunisation of sheep to prevent viraemia* and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
Danish: Til aktiv immunisering af får for at forebygge viræmi* og reducere kliniske tegn og læsioner forårsaget af bluetonguevirus serotype 1 og/eller 8 og/eller for at reducere viræmi* og kliniske tegn og læsioner forårsaget af bluetonguevirus serotype 4 (kombination af højst 2 serotyper).
English: Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1 RP* ≥ 1 Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 RP* ≥ 1 Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
Danish: Inaktiveret bluetonguevirus, serotype 1 (BTV-1), stamme ALG2006/01 E1 RP* ≥ 1 Inaktiveret bluetonguevirus, serotype 4 (BTV-4), stamme BTV-4/SPA-1/2004 RP* ≥ 1 Inaktiveret bluetonguevirus, serotype 8 (BTV-8), stamme BEL2006/01
English: For active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
Danish: Til aktiv immunisering af kvæg for at forebygge viræmi* forårsaget af bluetonguevirus serotype 1 og/eller 8 og/eller for at reducere viræmi* forårsaget af bluetonguevirus serotype 4 (kombination af højst 2 serotyper).
English: 4.2 Indications for use, specifying the target species
Danish: Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
English: Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 RP* ≥ 1 Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
Danish: Inaktiveret bluetonguevirus, serotype 4 (BTV-4), stamme BTV-4/SPA-1/2004 RP* ≥ 1 Inaktiveret bluetonguevirus, serotype 8 (BTV-8), stamme BEL2006/01
English: 4.5 Special precautions for use
Danish: Særlige forsigtighedsregler vedrørende brugen