FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment.
Danish: 4 Raterne for virusrecidiv er beregnet med patienter med ikke-detekterbart HCV-RNA ved EOT og med mindst én opfølgende HCV-RNA-måling som nævner.
English: 3 Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable)
Danish: 3 Raterne for virusrecidiv er beregnet med patienter med ikke-detekterbart (eller ubekræftet detekterbart) HCV-RNA ved behandlingsafslutning (EOT) som nævner.
English: Outcome for patients without SVR12 On-treatment failure2
Danish: Resultat for patienter, der ikke opnåede SVR12 Manglende effekt under behandling
English: studies: patients who did not achieve SVR with 150 mg simeprevir in combination with peginterferon alfa and ribavirin
Danish: Tabel 10: Behandlingsrelaterede aminosyresubstitutioner i puljede fase 2- og fase 3-studier: Patienter, der ikke opnåede SVR med 150 mg simeprevir i kombination med peginterferon alfa og ribavirin
English: Hepatic impairment
Danish: Udslæt og kløe
English: The 167 enrolled patients had a median age of 57 years (range 27 to 70 years; with 5% above 65 years); 64% were male; 81% were White, 19% Black or African American, and 21% Hispanic; 37% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.7 log10 IU/ml;
Danish: De 167 inkluderede patienter havde en medianalder på 57 år (27 til 70 år, heraf 5% over 65 år); 64% var mænd; 81% var hvide, 19% var sorte eller afroamerikanske, og 21% var latinamerikanske; 37% havde BMI ≥ 30 kg/m2; median HCV-RNA ved baseline var 6,7 log10 IE/ml; 75% havde ingen cirrose (METAVIR-fibrose-score F0-3), og 25% havde cirrose (METAVIR-fibrosescore F4); 78% havde HCV-genotype 1a, hvoraf 45% havde Q80K ved baseline, og 22% havde HCV-genotype 1b; 86% havde non-CC IL28B-alleler (CT eller TT); 76% var patienter med tidligere nul respons på peginterferon alfa og ribavirin, og 24% var behandlingsnaive.
English: Q80R3
Danish: D168E D168V Q80R3
English: (studies HPC3007 and C206) Treatment Outcome
Danish: (puljede data fra studie C208 og C216)
English: 1 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment.
Danish: 1 Raterne for virusrecidiv er beregnet med patienter med ikke-detekterbart HCV-RNA ved EOT og med mindst én opfølgende måling af HCV-RNA som nævner.
English: (moderate CYP3A4 enzyme induction)
Danish: (Moderat induktion af CYP3A4.)
English: 2 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment.
Danish: 2 Raterne for virusrecidiv er beregnet med patienter med ikke-detekterbart HCV-RNA ved EOT og med mindst én opfølgende måling af HCV-RNA som nævner.
English: Prior non-responder patients (including partial and null responders) with or without cirrhosis, with or without HIV co-infection
Danish: med eller uden cirrose, med eller uden HIV-coinfektion
English: Rash has been observed with OLYSIO combination treatment (see section 4.8).
Danish: Der er observeret udslæt hos patienter, der fik kombinationsbehandling med OLYSIO (se pkt.
English: It is not recommended to co-administer OLYSIO with products containing St John's wort as co-administration may result in loss of therapeutic effect of OLYSIO.
Danish: Det anbefales ikke at administrere OLYSIO sammen med præparater, der indeholder Perikon, da det kan medføre manglende terapeutisk virkning af OLYSIO.
English: Treatment-naïve and prior relapse patients2 with or without cirrhosis, who are not co-infected with HIV
Danish: med eller uden cirrose, uden HIV-coinfektion
English: Aluminium or
Danish: Calciumcarbonat
English: (mild to moderate CYP3A4 enzyme inhibition)
Danish: (Let til moderat hæmning af CYP3A4.)
English: In particular tell your doctor or pharmacist if you take any of the following medicines:
Danish: Spørg lægen eller apotekspersonalet, hvis du vil vide mere om disse lægemidler.
English: - The days of the week are printed on the blister strip - this will help you remember to take your capsule.
Danish: Det gør det nemmere for dig at huske at tage kapslen hver dag.
English: The company wanted the authorisation to be recognised in Belgium, Germany, Italy, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Danish: Virksomheden ønskede, at godkendelsen blev anerkendt i Belgien, Tyskland, Italien, Spanien, Sverige og Det Forenede Kongerige (de ”berørte medlemsstater”).
English: The review was carried out under an ‘Article 29' referral1.
Danish: Undersøgelsen blev gennemført i henhold til en ”artikel 29”-indbringelse1.
English: Ref. EMEA/CHMP/71684/2009 EMEA/H/A-29/1105
Danish: ref. EMEA/CHMP/466894/2009 rev. EMEA/H/A-29/1105
English: Questions and answers on the referral for Ciclosporin IDL and associated names capsules containing ciclosporin 25 mg, 50 mg and 100 mg
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Ciclosporin IDL og relaterede navne kapsler indeholdende ciclosporin 25 mg, 50 mg og 100 mg
English: Dr Robert James Hemmings
Danish: Dr. Robert James Hemmings Dr. Tomas Salmonson
English: London, 23 April 2009 Doc.
Danish: London, den 22. juli 2010 Dok.
English: However, because the concerned Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 2 December 2008.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og den nederlandske lægemiddelmyndighed henviste sagen til CHMP til voldgift den 2. december 2008.
English: In addition the Committee has also recommended that the marketing authorisation for Ciclosporin IDL in the Netherlands and other member states in the EU where the product has been authorised should be suspended until satisfactory bioequivalence data are obtained.
Danish: Derudover anbefalede udvalget, at markedsføringstilladelsen for Ciclosporin IDL i Nederlandene og andre EU-medlemsstater, hvor produktet er blevet godkendt, skal suspenderes, indtil der foreligger tilfredsstillende data om bioækvivalens.
English: Ciclosporin IDL is a generic medicine that is based on a reference medicine authorised in Germany (Sandimmun Optoral 25 mg capsules).
Danish: Ciclosporin IDL er et generisk lægemiddel, der er baseret på et referencelægemiddel, som er godkendt i Tyskland (Sandimmun Optoral 25 mg-kapsler).
English: What is Ciclosporin IDL?
Danish: Hvad er Ciclosporin IDL?
English: The company International Drug Licensing (IDL) submitted Ciclosporin IDL for mutual recognition on the basis of the initial authorisation granted by the Netherlands on 10 August 2007.
Danish: Virksomheden International Drug Licensing (IDL) indgav en ansøgning om gensidig anerkendelse af Ciclosporin IDL på baggrund af den oprindelige godkendelse, der blev udstedt i Nederlandene den 10. august 2007.
English: An autoimmune disease is a disease which is caused by the body's own defence system attacking normal tissue, such as psoriasis (a disease causing red, scaly patches on the skin), atopic dermatitis (eczema, an itchy red rash), nephrotic syndrome (a kidney disease) and rheumatoid arthritis (inflammation of the joints).
Danish: En autoimmun lidelse er en lidelse, som opstår, når kroppens eget forsvar angriber normalt væv, og omfatter lidelser såsom psoriasis (en sygdom, der giver røde skællende pletter på huden), atopisk dermatitis (eksem, kløende rødt udslæt), nefrotisk syndrom (en nyresygdom) og reumatoid arthritis (ledbetændelse).
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Ciclosporin IDL and the reference medicine had not been sufficiently demonstrated.
Danish: På grundlag af vurderingen af de aktuelt foreliggende data og den faglige drøftelse i udvalget var CHMP af den opfattelse, at der ikke i tilstrækkelig grad var påvist bioækvivalens mellem Ciclosporin IDL og referencelægemidlet.
English: The grounds for the referral were that five of the concerned Member States did not agree that enough evidence had been presented to show that Ciclosporin IDL was ‘bioequivalent' to the reference medicine.
Danish: Begrundelserne for indbringelsen af sagen var, at fem af de berørte medlemsstater ikke var enige i, at det var blevet tilstrækkeligt påvist, at Ciclosporin IDL var ”bioækvivalent” med referencelægemidlet.
English: Why was Ciclosporin IDL reviewed?
Danish: Hvorfor blev Ciclosporin IDL revurderet?
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Ciclosporin IDL.
Danish: Den 23. april 2009 gennemførte Det Europæiske Lægemiddelagentur (EMA) en voldgiftsprocedure som følge af uenighed blandt medlemsstater i Den Europæiske Union (EU) om godkendelsen af lægemidlet Ciclosporin IDL.
English: Referral start date:
Danish: Startdato for proceduren:
English: Ciclosporin IDL is also used to treat autoimmune diseases.
Danish: Ciclosporin IDL anvendes også til behandling af autoimmune lidelser.
English: The CHMP therefore concluded that the benefits of Ciclosporin IDL do not outweigh its risks, and that the marketing authorisation should not be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Ciclosporin IDL ikke opvejer risiciene, og at der derfor ikke bør udstedes markedsføringstilladelse i de berørte medlemsstater.
English: It is also used to treat or prevent graft-versus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Danish: Det bruges også til at behandle eller forebygge transplantat-mod-vært-reaktion (når immunsystemet i det transplanterede organ angriber patientens væv).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Ciclosporin IDL do not outweigh its risks, and that the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Ciclosporin IDL ikke opvejer risiciene, og at markedsføringstilladelsen, som er udstedt i Nederlandene, ikke kan anerkendes i andre EUmedlemsstater, og at markedsføringstilladelsen i Nederlandene skal suspenderes.
English: It acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in auto-immune diseases, normal tissue.
Danish: Det aktive stof i Ciclosporin IDL, ciclosporin, virker på særlige celler i immunsystemet kaldet Tceller, der er ansvarlige for at angribe transplanterede organer eller, ved autoimmune lidelser, normalt væv.
English: It is used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Danish: Det anvendes til at forebygge afstødning (når immunsystemet angriber transplanterede organer) hos patienter, der har fået en transplantation.
English: Company responses provided on: 16 January 2009 Opinion date:
Danish: Dato for virksomhedens svar:
English: Ciclosporin IDL is an immunosuppressive medicine.
Danish: Ciclosporin IDL er et immunundertrykkende lægemiddel (et lægemiddel, der dæmper immunsystemets aktivitet, dvs. kroppens naturlige forsvar).
English: A European Commission decision on this opinion will be issued in due course.
Danish: Europa-Kommissionen traf en afgørelse den 22. juli 2010.
English: The active substance in Ciclosporin IDL, ciclosporin, is an immunosuppressive agent.
Danish: Virksomheden, der fremstiller Ciclosporin IDL, International Drug Licensing, anmodede om, at udtalelsen blev taget op til fornyet overvejelse.
English: Powder: 500 U; Solvent: 5 ml
Danish: Pulver: 500 E; solvens: 5 ml
English: Intravenous use powder: vial (glass); solvent: vial (glass)
Danish: Intravenøs brug Pulver: hætteglas (glas); solvens: hætteglas (glas)
English: 500 U Powder and solvent for solution for injection
Danish: Pulver og solvens til injektionsvæske, opløsning
English: 2 disposable 10ml syringes 2 venipuncture sets
Danish: 2 filteroverførselsanordninger 2 injektionssprøjter til engangsbrug 10 ml
English: 2 protective mats
Danish: 2 venepunktursæt 2 beskyttelsesunderlag
English: 2 powder vials 2 solvent vials 2 filter transfer devices
Danish: 2 hætteglas med solvens
English: It may be used:
Danish: Det kan anvendes til:
English: This summary was last updated in September 2019.
Danish: Dette sammendrag blev sidst ajourført i september 2019.
English: Used pipettes should be disposed of immediately.
Danish: Brugte pipetter bør bortskaffes med det samme.
English: The veterinarian will decide if additional treatment is needed.
Danish: Dyrlægen vil afgøre, om der er behov for yderligere behandling.
English: Bravecto received a marketing authorisation valid throughout the EU on 11 February 2014.
Danish: Bravecto fik en markedsføringstilladelse med gyldighed i hele EU den 11. februar 2014.
English: Further information on Bravecto can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/bravecto.
Danish: Yderligere information om Bravecto findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/bravecto.
English: It takes up to 48 hours for the application site to become dry but it will be noticeable for longer.
Danish: Det tager op til 48 timer, før påføringsstedet er tørt, men det vil kunne ses længere.
English: The product should be kept in the original package until use, in order to prevent children directly accessing the medicine.
Danish: Lægemidlet skal opbevares i den originale pakning indtil brug for at undgå, at børn får direkte adgang til lægemidlet.
English: This product is harmful if swallowed.
Danish: Dette lægemiddel er skadeligt, hvis det indtages.
English: Other information about Bravecto
Danish: Andre oplysninger om Bravecto
English: As demodectic mange is caused by a number of factors, it is advisable for any underlying disease to be treated.
Danish: Da demodicose-skab er forårsaget af en række forskellige faktorer, er det tilrådeligt at behandle eventuel underliggende sygdom.
English: Contact with skin and/or eyes should be avoided including hand to eye contact.
Danish: Kontakt med hud og/eller øjne bør undgås, herunder berøring af øjnene med hænderne.
English: An overview of Bravecto and why it is authorised in the EU
Danish: En oversigt over Bravecto, og hvorfor det er godkendt i EU
English: What is Bravecto and what is it used for?
Danish: Hvad er Bravecto, og hvad anvendes det til?
English: Bravecto can only be obtained with a prescription.
Danish: Bravecto fås kun på recept.
English: Bravecto contains the active substance fluralaner.
Danish: Bravecto indeholder det aktive stof fluralaner.
English: Because parasites must start feeding on the dog or cat in order to be killed by the medicine, they might still be able to transmit any diseases with which they may be infected.
Danish: Da parasitter skal begynde at suge næring fra hunden eller katten for at blive dræbt af medicinen, kan de stadig overføre sygdomme, som de kan være inficeret med.
English: This includes cuddling the animal and sharing a bed with the animal.
Danish: Dette omfatter også at kæle med dyret og at have det liggende i sengen.
English: This means that it kills parasites that live on or in the skin or in the fur or ears of animals, such as fleas, ticks and mites.
Danish: Det vil sige, at det dræber parasitter, der lever på eller i huden eller i pelsen eller ørerne på dyr, såsom lopper, flåter og mider.
English: The European Medicines Agency decided that Bravecto'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 Bravecto opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For ear mite infestations, a veterinary check is advised 28 days after treatment.
Danish: Ved øremideangreb anbefales et kontrolbesøg hos dyrlægen 28 dage efter behandlingen.
English: What are the risks associated with Bravecto?
Danish: Hvilke risici er der forbundet med Bravecto?
English: Why is Bravecto authorised in the EU?
Danish: Hvorfor blev Bravecto godkendt i EU?
English: The animal's application site should no longer be noticeable before resuming contact with the site of application.
Danish: Påføringsstedet på dyret bør ikke længere være synligt, før påføringsstedet på ny berøres.
English: The effectiveness of Bravecto against fleas and ticks was investigated in both laboratory and field studies.
Danish: Effektiviteten af Bravecto mod lopper og flåter er undersøgt både i laboratorieundersøgelser og feltundersøgelser.
English: Bravecto spot-on solution and the wet skin of a recently treated animal may be slightly irritating to skin and/or eyes.
Danish: Bravecto-spot-on-opløsning og den våde hud af nyligt behandlede dyr kan virke let irriterende på hud og/eller øjne.
English: Bravecto is a veterinary medicine used to treat parasitic infestations in dogs and cats.
Danish: Bravecto er et veterinærlægemiddel, der anvendes til behandling af parasitinfektioner hos hunde og katte.
English: Fluralaner kills fleas, ticks and mites that have ingested the dog's or cat's blood by acting on their nervous system.
Danish: Fluralaner dræber lopper, flåter og mider, der har indtaget hundens eller kattens blod, ved at indvirke på deres nervesystem.
English: For more information about using Bravecto, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Bravecto, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: Bravecto tablets are given around the dog's feeding time as a tablet of the appropriate strength for the dog's bodyweight.
Danish: Bravecto-tabletter gives ved hundens fodringstid som en tablet af passende styrke i forhold til hundens kropsvægt.
English: Bravecto was effective against fleas and ticks for up to 12 weeks after treatment, and was as effective as fipronil in terms of the percentage of dogs and cats as well as households free of fleas and ticks.
Danish: Bravecto var effektivt mod lopper og flåter i op til 12 uger efter behandlingen og var lige så effektivt som fipronil, hvad angår procentdelen af hunde og katte og husholdninger, der var fri for lopper og flåter.
English: In case of spillage on table or floor surfaces, excess Bravecto spot-on solution should be removed using paper tissue and the area cleaned with a detergent.
Danish: Hvis der spildes på bordet eller gulvet, skal den overskydende Bravecto-spot-on-opløsning fjernes med en papirserviet, og området rengøres med et rengøringsmiddel.
English: The most common side effects of the tablets in dogs (which may affect more than 1 in 100 animals) are mild and short-lived diarrhoea, vomiting, lack of appetite and drooling.
Danish: De hyppigste bivirkninger af tabletterne hos hunde (som kan optræde hos over 1 ud af 100 dyr) er kortvarig let diarré, opkastning, appetitløshed og savlen.
English: The pipette to use is selected on the basis of the dog or cat's weight.
Danish: Den pipette, der skal anvendes, afpasses efter hundens eller kattens vægt.
English: In cats, Bravecto kills fleas within 12 hours and ticks within 48 hours.
Danish: Hos katte dræber Bravecto lopper i løbet af 12 timer og flåter i løbet af 48 timer.
English: • to treat demodectic and sarcoptic mange (skin infestation caused by two different mites) in dogs
Danish: • behandling af demodicose- og Sarcoptes-skab (skadedyrsangreb i huden forårsaget af to forskellige typer mider) hos hunde
English: People handling the medicine should not smoke, eat or drink and should wash their hands thoroughly after handling the product.
Danish: Ved håndtering af lægemidlet bør rygning og indtagelse af mad og drikke undgås, og efterfølgende bør man vaske hænder.
English: Bravecto and the comparator medicine were both 100% effective as all treated dogs were free from live mites when skin scrapings were taken on days 56 and 84 after treatment.
Danish: Bravecto og sammenligningslægemidlet var begge 100 % effektive, idet alle behandlede hunde var fri for levende mider, da der blev indsamlet afskrab fra huden på dag 56 og 84 efter behandling.
English: The content of one full Bravecto pipette is applied to the dog or cat's skin between the shoulder blades of the dog and at the base of the skull of the cat.
Danish: Indholdet af en fuld pipette med Bravecto påføres på hundens eller kattens hud mellem skulderbladene hos hunden og på kattens nakke ved kraniebunden.
English: For optimal tick control, treatment should be repeated every 8 to 12 weeks depending on the tick species.
Danish: For at opnå bedst mulig kontrol af flåtangreb bør behandlingen gentages hver 8.-12. uge, afhængigt af flåternes art.
English: The active substance in Bravecto, fluralaner, acts as an ‘ectoparasiticide'.
Danish: Det aktive stof i Bravecto, fluralaner, er et ektoparasitdræbende middel.
English: For dogs, several spots may be applied from the initial spot in a line to the base of the tail.
Danish: Til hunde kan der påføres spot-on-opløsning flere gange på en linje fra det første påføringssted til haleroden.
English: Fluralaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs' or cats' environment.
Danish: Fluralaner dræber lopperne, før de kan lægge æg, og nedsætter derved forekomsten af smitte til hundens eller kattens omgivelser.
English: The spot-on solution and tablets are available in different strengths for dogs and cats of different weights.
Danish: Spot-on-opløsningen og tabletterne fås i forskellige styrker til hunde og katte med forskellig vægt.
English: Bravecto spot-on solution should be kept away from heat, sparks, open flames or other fire sources as it is highly flammable.
Danish: Bravecto-spot-on-opløsning er meget brandfarlig og skal derfor holdes på afstand af varme, gnister, åben ild eller andre antændelseskilder.
English: In an EU field study involving 561 dogs with flea and/or tick infestations, the effects of Bravecto tablets were compared with those of another product, fipronil, that kills fleas and ticks, applied as a spot-on solution to the skin of the dogs.
Danish: I en feltundersøgelse i EU med 561 hunde med angreb af lopper og/eller flåter blev virkningerne af Bravecto i tabletform sammenlignet med virkningerne af et andet produkt, fipronil, der dræber lopper og flåter, og som påføres som spot-on-opløsning på hundens hud.
English: • to treat ear mite infestations in cats.
Danish: • behandling af øremideangreb hos katte.
English: The most common side effect of the spot-on solution (which may affect more than 1 in 100 animals) is a mild short-lived skin reaction at the application site, such as erythema (redness) and pruritus (itching) or hair loss.
Danish: Den hyppigste bivirkning af spot-on-opløsningen (som kan optræde hos mere end 1 ud af 100 dyr) er en kortvarig let hudreaktion på påføringsstedet såsom rødme (erytem) og kløe (pruritus) eller hårtab.
English: How does Bravecto work?
Danish: Hvordan virker Bravecto?
English: • as part of the management of flea allergy dermatitis (an allergic reaction to flea bites) in dogs and cats
Danish: • som led i behandling af loppeforårsaget dermatitis (en allergisk reaktion på loppebid) hos katte og hunde
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Hvis en person utilsigtet indtager lægemidlet, bør der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: In order to be exposed to the active substance, parasites must attach to the skin and commence feeding on the dog or cat.
Danish: For at parasitter kan blive udsat for det aktive stof, skal de først hægte sig fast i huden og begynde at tage næring fra hundens eller kattens blod.