FrancophonIA/ELRC3.0 huggingface dataset:
English: For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and lice.
Danish: INDIKATION(ER) Til behandling og forebyggelse af loppe- og flåtangreb og behandling af demodicose og lus.
English: Carefully dispose of used pipettes immediately after use.
Danish: Pipetterne skal omhyggeligt kasseres straks efter brug.
English: Do not administer to puppies under 8 weeks of age.
Danish: Må ikke anvendes til hvalpe under 8 uger.
English: If ill effects are noted following exposure to the product, seek immediate medical assistance, and show the product packaging to the physician.
Danish: Søg straks lægehjælp, hvis der bemærkes bivirkninger efter håndtering af produktet, og vis pakningsmaterialet til lægen.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001-010
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/065/001-010
English: For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis), and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.)
Danish: Til behandling og forebyggelse af loppeangreb (Ctenocephalides canis og C. felis) og flåter (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus og Dermacentor variabilis), og behandling af demodicose (forårsaget af Demodex spp.)
English: For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis) and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulates and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.)
Danish: Til behandling og forebyggelse af loppeangreb (Ctenocephalides canis og C. felis) og flåter (Ixodes ricinus, Ixodes hexagonu, Rhipicephalus sanguineus, Dermacentor reticulatus og Dermacentor variabilis), og behandling af demodicose (forårsaget af Demodex spp.)
English: The veterinary medicinal product remains effective if the animal becomes wet.
Danish: Præparater forbliver virksomt, selvom dyret bliver vådt.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients N, N-Diethyl-m-toluamide 1-Methoxy-2-propyl-acetate Dimethyl sulfoxide
Danish: N, N-Diethyl-m-toluamid 1-Methoxy-2-propylacetat Dimethylsulfoxid 1, 8-Cineole
English: for Small Dogs (≤ 5 kg) for Medium Sized Dogs - (5.1 - 10.0 kg) for Medium/Large Sized Dogs (10.1 - 25.0 kg) for Large Dogs (25.1 - 40.0 kg) for Extra Large Dogs (40.1 - 50.0 kg)
Danish: til små hunde (≤ 5 kg) til mellemstore hunde (5,1-10,0 kg) til mellemstore-store hunde (10,1-25,0 kg) til store hunde (25,1-40,0 kg) til ekstra store hunde (40,1-50,0 kg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card - Carton box for 2 blister cards
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske med 1 blisterkort - Papæske med 2 blisterkort
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN ”TIL DYR” Kun til dyr
English: Each unit dose (pipette) of ProMeris Duo delivers:
Danish: Èn enkeltdosis (pipette) ProMeris Duo indeholder:
English: ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs
Danish: ProMeris Duo 100,5 mg + 100,5 mg, Spot-on, opløsning til små hunde ProMeris Duo 199,5 mg + 199,5 mg, Spot-on, opløsning til mellemstore hunde ProMeris Duo 499,5 mg + 499,5 mg, Spot-on, opløsning til mellemstore-store hunde ProMeris Duo 799,5 mg + 799,5 mg, Spot-on, opløsning til store hunde ProMeris Duo 999 mg + 999 mg, Spot-on, opløsning til ekstra store hunde
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by the decision.
English: Do not apply the medicine to the surface of the dog's hair coat.
Danish: Præparatet må ikke påføres overfladen af hundens pels.
English: Each ml contains 150 mg metaflumizone and 150 mg amitraz.
Danish: Én ml indeholder 150 mg metaflumizon og 150 mg amitraz.
English: For further information see package leaflet.
Danish: Læs indlægssedlen for yderligere information.
English: ADVERSE REACTION*
Danish: BIVIRKNINGER*
English: Avoid contact with the eyes of the dog and avoid oral ingestion by the dog.
Danish: Undgå at præparatet kommer i kontakt med hundens øjne, eller at hunden indtager præparatet.
English: For optimal control of flea and/or tick infestation the product should be administered at monthly intervals throughout the flea and/or tick season, or the treatment schedule can be based on the local epidemiological situation.
Danish: For at opnå optimal kontrol af loppeangreb og/eller flåtangreb skal lægemidlet administreres hver 4. uge gennem hele loppe- og flåtsæsonen.
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the hair at the application site.
Danish: Påførsel af præparatet kan medføre lokal midlertidig fedtet eller sammenklumpet pels.
English: Metaflumizone and amitraz are combined in the final formulation to provide a broad spectrum of activity against both fleas and ticks, respectively, due to non-systemic exposure of the parasites on the skin and hair.
Danish: Metoflumizon og amitraz er kombineret i dette lægemiddel, hvilket resulterer i bred aktivitet mod henholdsvis lopper og flåter.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 6.66ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Foliepakning 6.66 ml
English: Each unit dose (pipette) of ProMeris Duo delivers: ProMeris Duo Spot-on for Dogs
Danish: Én enkeltdosis-pipette med ProMeris Duo indeholder: ProMeris Duo Spot-on
English: Box of 1 or 2 blister card of 3 x 0.67 ml pipettes Box of 1 or 2 blister card of 3 x 1.33 ml pipette Box of 1 or 2 blister card of 3 x 3.33 ml pipettes Box of 1 or 2 blister card of 3 x 5.33 ml pipettes Box of 1 or 2 blister card of 3 x 6.66 ml pipettes
Danish: Æske med 1 eller 2 blisterkort á 3 x 0,67 ml pipetter Æske med 1 eller 2 blisterkort á 3 x 1,33 ml pipetter Æske med 1 eller 2 blisterkort á 3 x 3,33 ml pipetter Æske med 1 eller 2 blisterkort á 3 x 5,33 ml pipetter Æske med 1 eller 2 blisterkort á 3 x 6,66 ml pipetter
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 999 mg + 999 mg
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 999 mg + 999 mg
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 6.66 ml pipette delivers:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Én 6,66 ml pipette indeholder:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 0.67ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Foliepakning 0,67 ml
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 799.5 mg + 799.5 mg
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 799,5 mg + 799,5 mg
English: Correct application will minimise licking of the application site.
Danish: Ved at påføre præparatet korrekt kan man minimere risikoen for at dyret slikker sig.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo XL
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo XL
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 100.5 mg + 100.5 mg
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 100,5 mg + 100,5 mg
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.67 ml pipette delivers:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Én 0,67 ml pipette indeholder:
English: ProMeris Duo for Small Dogs 5.1 - 10.0 ProMeris Duo Medium Sized Dogs 10.1 - 25.0 ProMeris Duo Spot-on for Medium/Large Sized Dogs 25.1 - 40.0 ProMeris Duo Spot-on for Large Dogs 40.1 - 50.0 ProMeris Duo Spot-on for Extra Large Dogs
Danish: ProMeris Duo til små hunde ProMeris Duo til mellemstore hunde 10,1-25,0 ProMeris Duo til mellemstore-store hunde ProMeris Duo til store hunde ProMeris Duo til ekstra store hunde
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo 100,5 mg + 100,5 mg Spot-on, opløsning til små hunde {≤ 5 kg}
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 199.5 mg + 199.5 mg
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 199,5 mg + 199,5 mg
English: Active substance: 100.5 mg metaflumizone and 100.5 mg amitraz
Danish: Aktivt stof: 100,5 mg metaflumizon og 100,5 mg amitraz
English: Part the hair and apply the contents of the pipette to a single spot on the skin of the dog at the base of the skull.
Danish: Del pelsen i nakken og påfør indholdet på samme sted på huden.
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for extra large dogs
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ PIPETTE til ekstra store hunde
English: Box of 1 blister card of 3 x 6.66 ml pipettes Box of 2 blister cards of 3 x 6.66 ml pipettes
Danish: Æske med 1 blisterkort med 3 x 6,66 ml pipetter Æske med 2 blisterkort med 3 x 6,66 ml pipetter
English: Active substance: 999 mg metaflumizone and 999 mg amitraz
Danish: Aktivt stof: 999 mg metaflumizon og 999 mg amitraz
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 1.33ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Foliepakning 1.33 ml
English: Active substance: 199.5 mg metaflumizone and 199.5 mg amitraz
Danish: Aktivt stof: 199,5 mg metaflumizon og 199,5 mg amitraz
English: Active substance: 799.5 mg metaflumizone and 799.5 mg amitraz
Danish: Aktivt stof: 799,5 mg metaflumizon og 799,5 mg amitraz
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo M/L
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo M/L
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs {10.1 - 25.0 kg}
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo 499,5 mg + 499,5 mg Spot-on, opløsning til mellemstore-store hunde {10,1 - 25,0 kg}
English: Active substance: 499.5 mg metaflumizone and 499.5 mg amitraz
Danish: Aktivt stof: 499,5 mg metaflumizon og 499,5 mg amitraz
English: Dermal exposure to the product should therefore be avoided.
Danish: Direkte kontakt med huden bør derfor undgås.
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for medium/large sized dogs
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ PIPETTE til mellemstore-store hunde
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo L
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo L
English: 5.1 - 10.0 ProMeris Duo Medium Sized Dogs 10.1 - 25.0 ProMeris Duo for Medium/Large Sized Dogs 25.1 - 40.0 ProMeris Duo for Large Dogs 40.1 - 50.0 ProMeris Duo for Extra Large Dogs
Danish: 10,1-25,0 ProMeris Duo til mellemstore-store hunde ProMeris Duo til store hunde
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 - 40.0 kg}
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo 799,5 mg + 799,5 mg Spot-on, opløsning til store hunde {25,1 - 40,0 kg}
English: Box of 1 blister card of 3 x 0.67 ml pipettes Box of 2 blister cards of 3 x 0.67 ml pipettes
Danish: Æske med 1 blisterkort med 3 x 0,67 ml pipetter Æske med 2 blisterkort med 3 x 0,67 ml pipetter
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 5.33ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Foliepakning 5.33 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo S
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo S
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for small dogs
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ PIPETTE til små hunde
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 3.33ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Foliepakning 3.33 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 - 50.0 kg}
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo 999 mg + 999 mg Spot-on, opløsning til ekstra store hunde {40,1 - 50,0 kg}
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.33 ml pipette delivers:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Én 1,33 ml pipette indeholder:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo M
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo M
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001 - 1 blister card of 3 pipettes of 0.67ml EU/2/06/065/002 - 2 blister cards of 3 pipettes of 0.67ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/065/001- 1 blisterkort af 3 x 0,67 ml pipetter EU/2/06/065/002 - 2 blisterkort af 3 x 0,67 ml pipetter
English: ProMeris Duo Spot-on for Small Dogs (≤ 5 kg)*
Danish: ProMeris Duo til små hunde ProMeris Duo til mellemstore hunde
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1 - 10.0 kg}
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris Duo 199,5 mg + 199,5 mg Spot-on, opløsning til mellemstore hunde {5,1 - 10,0 kg}
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for medium sized dogs
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ PIPETTE til mellemstore hunde
English: Box of 1 blister card of 3 x 5.33 ml pipettes Box of 2 blister cards of 3 x 5.33 ml pipettes
Danish: Æske med 1 blisterkort med 3 x 5,33 ml pipetter Æske med 2 blisterkort med 3 x 5,33 ml pipetter
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 5.33 ml pipette delivers:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Én 5,33 ml pipette indeholder:
English: Excipients
Danish: Pipette
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 3.33 ml pipette delivers:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Én 3,33 ml pipette indeholder:
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for large dogs
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ PIPETTE til store hunde
English: Box of 1 blister card of 3 x 3.33 ml pipettes Box of 2 blister cards of 3 x 3.33 ml pipettes
Danish: Æske med 1 blisterkort med 3 x 3,33 ml pipetter Æske med 2 blisterkort med 3 x 3,33 ml pipetter
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/009 - 1 blister card of 3 pipettes of 6.66 ml EU/2/06/065/010 - 2 blister cards of 3 pipettes of 6.66 ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/065/009 - 1 blisterkort af 3 x 6,66 ml pipetter
English: Amitraz is a monoamine oxidase inhibitor (MOAI); therefore, people taking MOAI-containing medication should take particular care when handling this product.
Danish: Personer, der tager MAO-hæmmere, bør derfor være særligt forsigtige under håndteringen af dette produkt.
English: Box of 1 blister card of 3 x 1.33 ml pipettes Box of 2 blister cards of 3 x 1.33 ml pipettes
Danish: Æske med 1 blisterkort med 3 x 1,33ml pipetter Æske med 2 blisterkort med 3 x 1,33ml pipetter
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/007 - 1 blister card of 3 pipettes of 5.33 ml EU/2/06/065/008 - 2 blister cards of 3 pipettes of 5.33 ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/065/007 - 1 blisterkort af 3 x 5,33 ml pipetter
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/003 - 1 blister card of 3 pipettes of 1.33ml EU/2/06/065/004 - 2 blister cards of 3 pipettes of 1.33ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/065/003 - 1 blisterkort af 3 x 1,33 ml pipetter
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/005 - 1 blister card of 3 pipettes of 3.33 ml EU/2/06/065/006 - 2 blister cards of 3 pipettes of 3.33 ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/065/005 - 1 blisterkort af 3 x 3,33 ml pipetter
English: This veterinary medicinal product is for spot-on application only.
Danish: Dette præparat er kun til brug på huden.
English: Patients were followed up for 3 years and could be given repeat treatment if appropriate.
Danish: Patienterne blev fulgt op i 3 år og kunne om nødvendigt gentage behandlingen.
English: Ozurdex received a marketing authorisation valid throughout the European Union on 27 July 2010.
Danish: Ozurdex fik en markedsføringstilladelse med gyldighed i hele EU den 27. juli 2010.
English: The bleeding is thought to be caused by the injection procedure and not by the medicine itself.
Danish: Blødningen menes at skyldes injektionsproceduren og ikke selve lægemidlet.
English: Further treatments can be given if the patient's condition improves but then gets worse and if the doctor believes that the patient will benefit from further treatment.
Danish: Der kan gives yderligere behandlinger, hvis patientens tilstand forbedres, men efterfølgende forværres, og hvis lægen mener, at patienten vil have gavn af yderligere behandling.
English: In addition, injections do not need to be given frequently because the implant stays in the eye for several months.
Danish: Det er desuden ikke nødvendigt at give hyppige injektioner, da implantatet forbliver i øjet i flere måneder.
English: Further information on Ozurdex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ozurdex.
Danish: Yderligere information om Ozurdex findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/ozurdex.
English: Ozurdex (dexamethasone)
Danish: Ozurdex (dexamethason)
English: It must also not be used in certain cases where the back of the membrane that surrounds the lens (the lens capsule) is torn.
Danish: Det må heller ikke anvendes i visse tilfælde, hvor bagsiden af den hinde, der omgiver linsen (linsekapslen), er revnet.
English: As for all medicines, data on the use of Ozurdex are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Ozurdex løbende overvåget.
English: • damage to blood vessels caused by diabetes in patients who have an artificial lens in their eye or in whom other treatment did not work or was unsuitable.
Danish: • beskadigelse af blodårer på grund af diabetes hos patienter, der har en kunstig linse i øjet, eller hos hvem anden behandling ikke har virket eller ikke var egnet.
English: In addition, the company that makes Ozurdex will ensure that patients are provided an information pack, including a booklet and an audio CD.
Danish: Desuden vil den virksomhed, der fremstiller Ozurdex, sikre, at patienterne modtager en informationspakke, herunder en folder og en lyd-CD.
English: The active substance in Ozurdex, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids.
Danish: Det aktive stof i Ozurdex, dexamethason, tilhører en gruppe af antiinflammatoriske lægemidler, som kaldes kortikosteroider.
English: The implant is made of a material that dissolves over several months while gradually releasing the dexamethasone.
Danish: Implantatet er fremstillet af et materiale, der opløses over flere måneder, og det frigiver løbende dexamethason.
English: Therefore the use of Ozurdex in patients with macular oedema related to diabetes was restricted to these two groups.
Danish: Brugen af Ozurdex hos patienter med diabetesrelateret makulært ødem var derfor begrænset til disse to grupper.
English: Each implant is in an applicator and contains 700 micrograms of the active substance, dexamethasone.
Danish: Hvert implantat leveres i en applikator og indeholder 700 mikrogram af det aktive stof, dexamethason.
English: It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation.
Danish: Det virker ved at trænge ind i celler og blokere produktionen af vaskulær endotelial vækstfaktor (VEGF) og prostaglandiner, stoffer, der er involveret ved betændelse.
English: Side effects reported with Ozurdex are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Ozurdex vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: • blockage of the veins carrying blood from the back of the eye;
Danish: • blokering af de vener, der fører blodet væk fra øjets bageste del
English: Eyesight was measured using the ‘best corrected visual acuity' (BCVA) indicating how well a person can see (after they have been given corrective lenses).
Danish: Synet blev målt ved hjælp af den "bedste korrigerede synsstyrke" (BCVA), der angiver, hvor godt en person kan se efter at have fået korrigerende linser.
English: Other information about Ozurdex
Danish: Andre oplysninger om Ozurdex
English: What measures are being taken to ensure the safe and effective use of Ozurdex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ozurdex?
English: An overview of Ozurdex and why it is authorised in the EU
Danish: En oversigt over Ozurdex, og hvorfor det er godkendt i EU
English: Patients whose vision gets better and stays better should not receive any more implants.
Danish: Patienter, hvis syn forbedres og forbliver bedre, bør ikke få flere implantater.
English: In the overall group of patients with macular oedema related to diabetes the Agency noted that the benefit was modest and was outweighed by the risks, including the development of cataracts.
Danish: I den samlede patientgruppe med diabetesrelateret makulært ødem bemærkede agenturet, at fordelen var beskeden og blev opvejet af risiciene, herunder udviklingen af grå stær.
English: For more information about using Ozurdex, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Ozurdex, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Patients whose vision is getting worse and is not improved by Ozurdex should also not receive any more implants.
Danish: Patienter, hvis syn bliver værre og ikke forbedres af Ozurdex, bør heller ikke få flere implantater.
English: In the second study, the figures were around 22% for Ozurdex after 90 days and 12% for the sham treatment.
Danish: I det andet studie var tallene ca. 22 % for Ozurdex efter 90 dage og 12 % for skinbehandlingen.
English: In two main studies involving a total of 1,267 adults Ozurdex was more effective than the sham treatment at improving patients' eyesight.
Danish: I to hovedstudier med i alt 1.267 voksne var Ozurdex mere effektivt end skinbehandlingen til at forbedre patienternes syn.
English: Because dexamethasone is a well-known anti-inflammatory medicine, the company presented studies from the published literature where Ozurdex was compared with a ‘sham' treatment (where an applicator was pressed against their eye but nothing was actually injected).
Danish: Da dexamethason er et velkendt antiinflammatorisk lægemiddel, fremlagde virksomheden studier fra den offentliggjorte litteratur, hvor Ozurdex blev sammenlignet med en skinbehandling (hvor en applikator blev presset mod øjet, men uden at foretage injektionen).
English: Why is Ozurdex authorised in the EU?
Danish: Hvorfor er Ozurdex godkendt i EU?
English: This ensures that adequate amounts of dexamethasone reach the area inside the eye where the inflammation in macular oedema and uveitis occurs.
Danish: Dette sikrer, at der gives en passende mængde dexamethason i den del af øjet, hvor betændelsen i makulært ødem og uveitis befinder sig.
English: Ozurdex injection causes only minor trauma to the eyeball and the increase in intraocular pressure is considered to be manageable.
Danish: Injektionen af Ozurdex forårsager kun mindre traumer mod øjeæblet, og det øgede tryk i øjet vurderes at være håndterbart.
English: What is Ozurdex and what is it used for?
Danish: Hvad er Ozurdex, og hvad anvendes det til?