FrancophonIA/ELRC3.0 huggingface dataset:
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 DuoTrav.
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 DuoTrav.
English: By lowering the pressure, DuoTrav reduces the risk of damaging these structures.
Danish: Ved at sænke trykket mindsker DuoTrav risikoen for beskadigelse af disse strukturer.
English: It contains two active substances: travoprost (40 micrograms per millilitre) and timolol (5 mg/ml).
Danish: Det indeholder to aktive stoffer: travoprost (40 mikrogram/ml) og timolol (5 mg/ml).
English: Other information about DuoTrav:
Danish: Andre oplysninger om DuoTrav:
English: DuoTrav reduced the pressure inside the eye by about a third in all of the studies (the average reduction was about 8-10 mmHg).
Danish: DuoTrav nedsatte trykket i øjet med cirka en tredjedel i alle undersøgelserne (den gennemsnitlige nedsættelse var på omkring 8-10 mmHg).
English: DuoTrav taken in the evening was as effective as DuoTrav taken in the morning.
Danish: DuoTrav taget om aftenen var lige så effektivt som DuoTrav taget om morgenen.
English: DuoTrav can only be obtained with a prescription.
Danish: DuoTrav udleveres kun efter recept.
English: In a patient with glaucoma, the eye pressure is usually higher than 21 mmHg.
Danish: Hos patienter med glaukom er trykket i øjet normalt højere end 21 mmHg.
English: For more information about treatment with DuoTrav, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med DuoTrav, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
Danish: Kombinationen af de to aktive stoffer har en additiv virkning og mindsker trykket i øjet mere end de enkelte lægemidler alene.
English: DuoTrav contains benzalkonium chloride which is known to discolour soft contact lenses.
Danish: DuoTrav indeholder benzalkoniumchlorid, der er kendt for at blege bløde kontaktlinser.
English: In all of the studies, the main measure of effectiveness was the change in pressure inside the eye measured in ‘millimetres of mercury' (mmHg).
Danish: I alle undersøgelserne blev virkningen hovedsagelig bedømt på trykændringen i øjet målt i ”millimeter kviksølv” (mmHg).
English: When the pressure inside the eye rises, it causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Danish: Når trykket i øjet stiger, forårsager det skader på nethinden (den lysfølsomme membran bagest i øjet) og på den optiske nerve, som sender signaler fra øjet til hjernen.
English: What is the risk associated with DuoTrav?
Danish: Hvilke risici er der forbundet med DuoTrav?
English: The full EPAR for DuoTrav is available here.
Danish: Den fuldstændige EPAR for DuoTrav findes her.
English: DuoTrav has been studied in five main studies involving a total of 1,482 patients (aged 18 to 91) with open-angle glaucoma or ocular hypertension.
Danish: DuoTrav er blevet undersøgt i fem hovedundersøgelser af i alt 1 482 patienter (i alderen 18 til 91 år) med åbenvinket glaukom eller okulær hypertension.
English: The CHMP decided that DuoTrav's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved DuoTrav opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for DuoTrav.
English: The dose of DuoTrav is one drop in the affected eye(s) once a day, in the morning or evening, at the same time every day.
Danish: Doseringen af DuoTrav er én dråbe i det eller de pågældende øjne én gang dagligt, morgen eller aften, på samme tidspunkt hver dag.
English: It was as effective as the two medicines given as separate eye drops, and as effective as eye drops containing both latanoprost and timolol.
Danish: Det var lige så effektivt som de to aktive stoffer indgivet som øjendråber hver for sig, og lige så effektivt som øjendråber indeholdende både latanoprost og timolol.
English: The fifth was a 12-month study that compared DuoTrav with eye drops containing a combination of latanoprost (another prostaglandin analogue) and timolol.
Danish: I den femte undersøgelse, som varede 12 måneder, sammenlignedes DuoTrav med øjendråber indeholdende en kombination af latanoprost (en anden prostaglandinanalog) og timolol.
English: DuoTrav was more effective at reducing the pressure inside the eye than timolol on its own, or travoprost on its own.
Danish: DuoTrav var mere effektivt til at nedsætte trykket i øjet end timolol alene eller travoprost alene.
English: DuoTrav is used to reduce the pressure inside the eye.
Danish: DuoTrav anvendes til at nedsætte trykket i øjet.
English: Therefore, care should be taken by people who wear soft contact lenses.
Danish: Personer, som bruger bløde kontaktlinser, bør derfor anvende lægemidlet med forsigtighed.
English: Three studies compared DuoTrav with travoprost and timolol either given on their own, or together but as separate eye drops.
Danish: I tre undersøgelser sammenlignedes DuoTrav med travoprost og timolol givet alene eller sammen, men som separate øjendråber.
English: DuoTrav must not be used in people with asthma or severe lung disease, or in people with some heart conditions.
Danish: DuoTrav må ikke anvendes til patienter med astma eller alvorlige lungelidelser, eller til patienter med visse hjertelidelser.
English: It must also not be used in people with severe allergic rhinitis (inflammation of the nasal passages caused by an allergy) and corneal dystrophies (disorders that cause clouding of the cornea, the transparent layer in front of the eye).
Danish: Det må heller ikke anvendes til personer med alvorlig allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi) eller hornhindedystrofier (lidelser, der kan medføre tilsløring af hornhinden, som er det gennemsigtige lag forrest i øjet).
English: The most common side effects with DuoTrav (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to redness) and eye irritation.
Danish: De hyppigste bivirkninger ved DuoTrav (som optræder hos flere end 1 ud af 10 patienter) er okulær hyperæmi (øget blodtilstrømning til øjet, hvilket fører til rødmen) og øjenirritation.
English: In open angle glaucoma the high pressure is caused by fluid being unable to drain out of the eye.
Danish: Ved åbenvinklet glaukom skyldes det høje tryk i øjet, at væsken ikke kan føres ud af øjet.
English: It is used in adults with ‘open angle glaucoma' or ‘ocular hypertension' who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).
Danish: Det anvendes til voksne med ”åbenvinklet glaukom” eller ”okulær hypertension”, som responderer utilstrækkeligt på øjendråber, der indeholder betablokkere eller prostaglandinanaloger (andre lægemidler til behandling af disse lidelser).
English: DuoTrav may cause the iris of the eye to change colour (darken) and the eyelashes to thicken, darken or lengthen.
Danish: DuoTrav kan give farveforandring af øjets regnbuehinde (så den bliver mørkere) og kan gøre øjenvipperne tykkere, mørkere eller længere.
English: Why has DuoTrav been approved?
Danish: Hvorfor blev DuoTrav godkendt?
English: DuoTrav should not be used in people who may be hypersensitive (allergic) to travoprost, timolol (and other beta-blockers), or any of the other ingredients.
Danish: DuoTrav må ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for travoprost, timolol (og andre betablokkere) eller andre af indholdsstofferne.
English: One study compared DuoTrav taken in the morning with DuoTrav taken in the evening.
Danish: I én undersøgelse sammenlignedes effekten af DuoTrav taget om morgenen med DuoTrav taget om aftenen.
English: For the full list of all side effects reported with DuoTrav, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved DuoTrav fremgår af indlægssedlen.
English: What is DuoTrav?
Danish: Hvad er DuoTrav?
English: What is DuoTrav used for?
Danish: Hvad anvendes DuoTrav til?
English: How has DuoTrav been studied?
Danish: Hvordan blev DuoTrav undersøgt?
English: DuoTrav is a clear eye drop solution.
Danish: DuoTrav er øjendråber (en klar opløsning).
English: Ocular hypertension is when the pressure in the eye is higher than normal.
Danish: Okulær hypertension er unormalt højt tryk i øjet.
English: Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been used to treat glaucoma since the 1970's.
Danish: Timolol har været anvendt til behandling af glaukom (grøn stær) siden 1970´erne.
English: What benefit has DuoTrav shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved DuoTrav?
English: Travoprost is a prostaglandin analogue (a man-made copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Travoprost on its own has been authorised in the European Union as Travatan since 2001.
Danish: DuoTrav indeholder to aktive stoffer, travoprost og timolol, som sænker trykket i øjet på forskellig vis. Travoprost er en prostaglandinanalog (en kunstigt fremstillet kopi af det naturlige stof prostaglandin), der virker ved at øge afstrømningen af væske fra øjet.
English: How does DuoTrav work?
Danish: Hvordan virker DuoTrav?
English: How is DuoTrav used?
Danish: Hvordan anvendes DuoTrav?
English: Powder for oral suspension
Danish: 25 mg Pulver til oral suspension
English: Oral use sachet (PET/OPA/alu/LDPE)
Danish: Oral anvendelse brev (PET/OPA/alu/LDPE) 30 breve + 1 blandeflaske +
English: MA (EU) number (Invented) name Strength
Danish: MF (EU)-nummer
English: 30 sachets + 1 mixing bottle + 30 single-use oral syringes + 1 screw cap with syringe-port capability
Danish: 30 orale doseringssprøjter til engangsbrug +
English: l Suspension (inactivated)
Danish: Suspension (inaktiveret)
English: Content Package size
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: EU (MA) number
Danish: EU-nummer
English: Rabies virus, strain SAD Vnukovo-32
Danish: Rabiesvirus, stamme SAD Vnukovo-32
English: --1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
Danish: --1 Lyofilisat (levende svækket) Hundeparainfluenza type 2 virus, stamme CPiV-2-Bio 15
English: Withdraw al period
Danish: Tilbageholdelsestid
English: Target specie s
Danish: Særnavn Styrke Lægemiddelfor m
English: Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091
Danish: Leptospira kirschneri serogruppe Grippotyphosa serovar Grippotyphosa, stamme MSLB 1091
English: Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089
Danish: Leptospira interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae, stamme MSLB 1089
English: Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088
Danish: Leptospira interrogans serogruppe Australis serovar Bratislava, stamme MSLB 1088
English: Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB 1090
Danish: Leptospira interrogans serogruppe Canicola serovar Canicola, stamme MSLB 1090
English: ** Antibody micro agglutination-lytic reaction.
Danish: ≥ 2.0 IU*** * Vævskulturinficerende dosis - 50 % (tissue culture infectious dose 50 %) ** Antistof mikroagglutinationsreaktion - lytisk reaktion (antibody micro agglutination-lytic reaction) *** Internationale enheder
English: Pharmaceutic al form
Danish: Dyrearter, som lægemidlet er beregnet til
English: **Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Danish: * Relativ styrke bestemt ved en styrketest med mus, som blev sammenlignet med referencevaccine, der blev vist virksom hos får
English: Withdrawal period
Danish: Tilbagehold elsestid
English: Strength Pharmaceutical Form
Danish: EU-nummer Særnavn Styrke Lægemiddelform
English: EMEA/681318/2008-EN
Danish: EMEA/681318/2008-DA
English: The assessment report and the opinion were transferred to the European Commission for decision.
Danish: Vurderingsrapporten og udtalelsen blev sendt til afgørelse hos Europa-Kommissionen.
English: The final opinion was converted into a Decision by the European Commission on 30 April 2009.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 30. April
English: (International Non-Proprietary Name (INN): Xylazine, Medetomidine, Detomidine, Romifidine)
Danish: (Internationalt fællesnavn (INN): xylazin, medetomidin, detomidin, romifidin)
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Danish: UDVALGET FOR VETERINÆRLÆGEMIDLER (CVMP)
English: Member States identified and informed the Agency of the concerned marketing authorisations in their respective territories.
Danish: Medlemsstaterne identificerede og informerede agenturet om de pågældende markedsføringstilladelser i de enkelte stater.
English: The veterinarian experienced cardiovascular and central nervous system effects over a period of 3 days.
Danish: Dyrlægen oplevede virkninger i hjerte-/karsystemet og centralnervesystemet over en periode på tre dage.
English: Additionally, the CVMP concluded that the need for updating the product literature to reflect the matters above is not urgent.
Danish: Desuden konkluderede CVMP, at behovet for at opdatere produktdokumentationen, så den omfatter ovenstående, ikke er presserende.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II.
English: The Committee reconfirmed Dr A. Holm as Rapporteur and Dr P. Ekström as Co-Rapporteur for the procedure.
Danish: Udvalget bibeholdt Dr. A. Holm som rapportør og Dr. P. Ekström som medrapportør under proceduren.
English: Dr Anja Holm was appointed as Rapporteur and Dr Peter Ekström as Co-Rapporteur.
Danish: Dr. Anja Holm blev udpeget til rapportør, og Dr. Peter Ekström blev udpeget til medrapportør.
English: Xylazine, detomidine, medetomidine and romifidine are alpha2-adrenoreceptor agonists.
Danish: Xylazin, detomidin, medetomidin og romifidin er alfa-2-adrenoreceptoragonister.
English: The CVMP concluded that, on the basis of the available data, there is at present a potential risk to human health posed by the use of products containing alpha2-adrenoreceptor agonists, and issued a revised opinion on 12 November 2008.
Danish: CVMP konkluderede på baggrund af de tilgængelige oplysninger, at der for øjeblikket er en potentiel helbredsrisiko for mennesker ved brug af lægemidler, der indeholder alfa-2-adrenoreceptoragonister, og afgav en revideret udtalelse den 12. november 2008.
English: Alpha2-adrenoreceptor agonists are pharmaceutically active substances that are commonly used to induce effects such as sedation, analgesia and muscle relaxation.
Danish: Alfa-2-adrenoreceptoragonister er farmakologisk virksomme stoffer, der er almindeligt anvendt til fremkaldelse af bl.a. sedation, analgesi og muskelafslapning.
English: The basis for the notification was a suspected adverse reaction report received in The Netherlands after a veterinarian accidentally injected himself with the product Sedivet, which contains romifidine as the active ingredient.
Danish: Baggrunden for meddelelsen var en indberetning i Nederlandene om formodede bivirkninger, efter at en dyrlæge ved et uheld havde injiceret sig selv med lægemidlet Sedivet, som indeholder det aktive stof romifidin.
English: On 13 September 2006 the procedure was initiated by adoption of a list of questions to be put to the concerned Marketing Authorisation Holders.
Danish: Proceduren blev indledt den 13. september 2006 med vedtagelse af en liste med spørgsmål, der skulle forelægges de pågældende indehavere af markedsføringstilladelserne.
English: OPINION FOLLOWING AN ARTICLE 781 PROCEDURE FOR Veterinary medicinal products containing Alpha2-adrenoreceptor agonists2
Danish: UDTALELSE SOM FØLGE AF EN PROCEDURE I HENHOLD TIL ARTIKEL 781 Veterinærlægemidler indeholdende alfa-2-adrenoreceptoragonister2
English: A revised list of questions addressed to the concerned Marketing Authorisation Holders was adopted on 16 July 2008.
Danish: En revideret liste over spørgsmål til de pågældende indehavere af markedsføringstilladelser blev vedtaget den 16. juli 2008.
English: Following further communication with the European Commission in years 2007 and 2008 on the opinion and the scope of the procedure, the CVMP in the July 2008 plenary meeting agreed to complete the procedure under Article 78 of Directive 2001/82/EC, as amended, for all marketing authorisations held in the EU for the 21 products containing alpha2-adrenoreceptor agonists initially notified and to revise the initial opinion accordingly.
Danish: I forlængelse af den videre kommunikation med Europa-Kommissionen i 2007 og 2008 om udtalelsen og procedurens omfang vedtog CVMP på plenarmødet i juli 2008 at afslutte proceduren i henhold til artikel 78 i direktiv 2001/82/EF, med senere ændringer, for alle de markedsføringstilladelser, der måtte være i Den Europæiske Union for de 21 oprindeligt indberettede produkter indeholdende alfa-2adrenoreceptoragonister, og revidere den oprindelige udtalelse i henhold hertil.
English: The extrapolation of the proposed warnings for one alpha2-adrenoreceptor agonist to other alpha2adrenoreceptor agonists was considered justified, since the pharmacological mode of action is the same and because several of the substances have shown similar effects in humans.
Danish: Ekstrapoleringen af de foreslåede advarsler for én alfa-2-adrenoreceptoragonist til andre alfa-2-adrenoreceptoragonister blev vurderet som begrundet, da de har samme farmakologiske virkemåde, og fordi flere af stofferne har haft tilsvarende virkninger hos mennesker.
English: No new substantial data was provided by any of the responding Marketing Authorisation Holders and therefore the assessment remains based on the data considered in 2006.
Danish: Indehaverne af markedsføringstilladelserne fremlagde ingen væsentlige nye oplysninger, hvorfor vurderingen er baseret på oplysningerne fra
English: Written responses were received by Marketing Authorisation Holders for 81 of the 108 notified authorisations held by a total of 66 Marketing Authorisation Holders by 16 September 2008.
Danish: Den 16. september 2008 havde indehaverne af markedsføringstilladelserne modtaget skriftlige svar for 81 af de 108 identificerede markedsføringstilladelser, som er fordelt på 66 indehavere.
English: The concerned Marketing Authorisation Holders were informed accordingly by a letter dated 13 December 2006.
Danish: De pågældende indehavere af markedsføringstilladelserne blev dernæst informeret ved brev af 13. december 2006.
English: The Committee considered that specific precautionary measures should be reflected in the product literature of concerned products containing alpha2-agonists.
Danish: Udvalget vurderede, at der skulle indføjes specifikke forholdsregler i produktdokumentationen for de pågældende lægemidler indeholdende alfa-2-adrenoreceptoragonister.
English: In accordance with Article 78(3) of Directive 2001/82/EC, as amended, the Committee for Medicinal Products for Veterinary Use (CVMP) is to give its opinion on the conclusions and intended risk management measures presented by the notifying Authority which in this procedure was the Dutch Medicines Evaluation Board.
Danish: Udvalget for Veterinærlægemidler (CVMP) skal i henhold til artikel 78, stk. 3, i direktiv 2001/82/EF, med senere ændringer, afgive en udtalelse om de konklusioner og risikostyringsforanstaltninger, der er fremlagt af den indberettende myndighed, som i dette tilfælde var den nederlandske lægemiddelstyrelse.
English: During its December 2006 meeting, the CVMP, in light of the overall data submitted, additional data from the public domain and the scientific discussion within the Committee, adopted by consensus an opinion concerning the 21 veterinary medicinal products as authorised in the Netherlands.
Danish: På baggrund af de indsendte oplysninger, yderligere offentligt tilgængelige oplysninger og den faglige drøftelse i udvalget vedtog CVMP på mødet i december 2006 ved konsensus en udtalelse vedrørende de 21 veterinærlægemidler, som er godkendt i Nederlandene.
English: The College Ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board, The Netherlands), in accordance with Article 78(1) of Directive 2001/82/EC, as amended by Directive 2004/28/EC, informed the EMEA by a letter dated 25 August 2006 of its intention to vary the marketing authorisation and to add a new precautionary measure for 21 veterinary medicinal products containing alpha2-adrenoreceptor agonists authorised in The Netherlands.
Danish: I et brev af 25. august 2006 meddelte College Ter Beoordeling van Geneesmiddelen (den nederlandske lægemiddelstyrelse) i henhold til artikel 78, stk. 1, i direktiv 2001/82/EF, som ændret ved direktiv 2004/28/EF, EMEA sin beslutning om at ændre markedsføringstilladelserne og tilføje en ny forholdsregel for 21 veterinærlægemidler indeholdende alfa-2-adrenoreceptoragonister, som er godkendt i Nederlandene.
English: Written explanations were provided by the Marketing Authorisation Holders on 13 October 2006.
Danish: Indehaverne af markedsføringstilladelserne fremsendte skriftlige redegørelser den 13. oktober 2006.
English: 1 Article 78 of Directive 2001/82/EC, as amended See Annex I for the complete list of concerned products
Danish: 1 Artikel 78 i direktiv 2001/82/EF, med senere ændringer.
English: powder: 3 ml solvent: 5 ml
Danish: pulver: 3 ml opløsning: 5 ml
English: 0.9 mg Powder and solvent for solution for injection
Danish: 0.9 mg pulver og solvens til injektionsvæske, opløsning
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage
English: Intralesional use powder: vial (glass) solvent: vial (glass)
Danish: Intralæsional anvendelse pulver: hætteglas (glas) opløsning: hætteglas (glas)
English: 1 vial + 1 vial
Danish: 1 hætteglas 1 hætteglas
English: Veterinary Medicines Division
Danish: Veterinærlægemiddeldivisionen
English: Outcome of a procedure under Article 33(4) of Directive 2001/82/EC, as amended
Danish: Resultatet af en procedure i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, som ændret
English: The European Commission issued a decision on 28 August 2015.
Danish: Europa-Kommissionen traf en beslutning den 28. august 2015.
English: The company wanted the authorisation to be recognised in other EU Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom).
Danish: Virksomheden ønskede godkendelsen anerkendt i andre EU medlemsstater (de "berørte medlemsstater", i dette tilfælde Østrig, Belgien, Bulgarien, Kroatien, Cypern, Tjekkiet, Estland, Finland, Tyskland, Grækenland, Island, Irland, Italien, Letland, Litauen, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Sverige og Det Forenede Kongerige).
English: What are the conclusions of the CVMP?
Danish: Hvilke konklusioner drog CVMP?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 August 2015
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28.