FrancophonIA/ELRC3.0 huggingface dataset:
English: In each Phase III study and the pooled analysis, the time to achieve ≥ 15 letters (3-line) improvement in BCVA cumulative response curves were significantly different with OZURDEX compared to sham (p < 0.001) with OZURDEX treated patients achieving a 3-line improvement in BCVA earlier than sham treated patients.
Danish: I hvert fase III-studie og i den puljede analyse var der væsentlige forskelle i den tid, det tog at opnå en forbedring på ≥ 15 bogstaver (3 linjer) i de kumulative BCVA-responskurver med OZURDEX sammenlignet med sham (p < 0,001), hvor OZURDEX-behandlede patienter tidligere opnåede en forbedring på 3 linjer i BCVA i forhold til sham-behandlede patienter.
English: The clinical safety of OZURDEX in patients with diabetic macular oedema was assessed in two phase 3 randomized, double-masked, sham-controlled studies.
Danish: OZURDEX' kliniske sikkerhed hos patienter med diabetisk maculaødem blev vurderet i to randomiserede, dobbeltblindede, sham-kontrollerede fase III-studier.
English: Dexamethasone is excreted in breast milk No effects on the child are anticipated due to the route of administration and the resulting systemic levels.
Danish: Der forventes dog ingen påvirkning af barnet på grund af indgivelsesmåden og de resulterende systemiske niveauer.
English: Intravitreal implant in applicator.
Danish: Intravitrealt implantat i applikator.
English: During the initial treatment period, 0.7 % (3/421) of the patients who received OZURDEX required laser or surgical procedures for management of elevated IOP in the study eye compared with 0.2 % (1/423) with sham.
Danish: I løbet af den indledende behandlingsperiode krævedes laserbehandling eller operation for at håndtere forhøjet IOP i forsøgsøjet hos 0,7 % (3/421) af de patienter, som fik OZURDEX, sammenlignet med 0,2 % (1/423), som fik sham.
English: What OZURDEX is and what it is used for What you need to know before you are given OZURDEX How OZURDEX is used
Danish: Virkning og anvendelse Det skal du vide, før du får OZURDEX Sådan får du OZURDEX Bivirkninger
English: Week 8
Danish: Uge 8
English: Studies in animals have shown teratogenic effects following topical ophthalmic administration (see section 5.3).
Danish: Studier hos dyr har vist teratogene virkninger efter intraokulær anvendelse (se pkt.
English: Week 20
Danish: Uge 20
English: The OZURDEX applicator is for single use only.
Danish: OZURDEX-applikatoren er kun til engangsbrug.
English: Other medicines and OZURDEX
Danish: Brug af anden medicin sammen med OZURDEX
English: The clinical safety of OZURDEX in patients with macular oedema following central or branch retinal vein occlusion has been assessed in two Phase III randomised, double-masked, sham-controlled studies.
Danish: OZURDEX' kliniske sikkerhed hos patienter med maculaødem efter retinal central- eller grenveneokklusion (BRVO) er blevet vurderet i to randomiserede, dobbeltmaskerede, shamkontrollerede fase III-studier.
English: OZURDEX 700 micrograms intravitreal implant in applicator
Danish: OZURDEX 700 mikrogram intravitrealt implantat i applikator
English: High pressure in the eye, clouding at the back of the lens, bleeding into the inside of the eye*, worsening of vision*, difficulties in seeing clearly, detachment of the jelly inside the eye from the light-sensitive layer at the back of the eye (vitreous detachment)*, a feeling of spots in front of the eye (including ‘floaters')*, a feeling of looking through mist or fog*, inflammation of the eyelid, eye pain*, seeing flashes of light*, swelling of the layer over the white part of the eye*, redness of the eye*, headache
Danish: Højt tryk i øjet, uklarhed i det bageste af linsen, blødning i det indre øje *, forringet syn*, vanskeligheder ved at se klart, løsrivelse af det geleagtige legeme i det indre øje fra det lysfølsomme lag bagest i øjet (løsrivelse af glaslegemet)*, fornemmelse af pletter for øjet (herunder 'flyvende fluer')*, fornemmelse af at se gennem dis eller tåge*, inflammation (betændelseslignende reaktion) i øjenlåget, øjensmerter*, lysblink*, hævelse af laget over den hvide del af øjet*, rødme i øjet*, hovedpine
English: Efficacy in patients with any prior treatment (pooled studies 206207-010 and 206207
Danish: Virkning hos patienter med tidligere behandling (Puljede studier 206207-010 og
English: In DME, anti-coagulant therapy was used in 8% of patients.
Danish: Ved DME fik 8 % af patienterne antikoagulantia.
English: Patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs (see section 4.4).
Danish: Patienterne skal overvåges efter injektionen for at kunne iværksætte tidlig behandling ved forekomst af infektion eller forhøjet intraokulært tryk (se pkt.
English: One carton contains one applicator with one implant which will be used once and thrown away.
Danish: Hver karton indeholder en applikator med et implantat til engangsbrug.
English: The proportion of patients with at least 15 letters improvement from baseline BCVA in the study eye at week 8 was more than 6-fold higher with OZURDEX (42.9%) compared to Sham (6.6%), p < 0.001.
Danish: Andelen af patienter med en forbedring i forsøgsøjet på mindst 15 bogstaver i forhold til BCVA (Best Corrected Visual Acuity) ved baseline var efter 8 uger mere end 6 gange højere med OZURDEX (42,9 %) end med sham (6,6 %) (p < 0,001).
English: Description of selected adverse reactions Diabetic Macular Oedema
Danish: Beskrivelse af udvalgte bivirkninger Diabetisk maculaødem
English: In BRVO/CRVO clinical studies, cataract was reported more frequently in patients with phakic lens receiving a second injection (see section 4.8).
Danish: Der er i kliniske BRVO-/CRVO-studier hyppigere rapporteret om katarakt hos patienter med fakisk linse, der har fået endnu en injektion (se pkt.
English: Other than those patients contraindicated (see section 4.3) where OZURDEX should not be used, OZURDEX should be used with caution and only following a careful risk benefit assessment.
Danish: 4.3 i produktresuméet) og ikke bør anvendes, skal OZURDEX anvendes med forsigtighed og kun efter omhyggelig vurdering af risici/fordele.
English: Detailed instructions for your doctor on how to carry out the OZURDEX injection are provided in the medicine carton.
Danish: Æsken med lægemidlet indeholder detaljerede instruktioner til lægen om, hvordan OZURDEXinjektionen skal gives.
English: OZURDEX must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Danish: OZURDEX skal indgives af en speciallæge i oftalmologi med erfaring i injektioner i corpus vitreum.
English: A total of 4 patients (1%) treated with OZURDEX had procedures in the study eye for the treatment of IOP elevation.
Danish: I alt 4 patienter (1 %), der blev behandlet med OZURDEX, gennemgik en operation i forsøgsøjet til behandling af forhøjet intraokulært tryk.
English: Ocular hypertension, cataract subcapsular, vitreous haemorrhage**, visual acuity reduced*, visual impairment/ disturbance, vitreous detachment*, vitreous floaters*, vitreous opacities*, blepharitis, eye pain*, photopsia*, conjunctival oedema* conjunctival hyperaemia*
Danish: Okulær hypertension, subkapsulær katarakt, glaslegemeblødning**, forringet klarsyn*, synsforringelse/-forstyrrelse, glaslegemeløsning*, flyvende fluer*, glaslegemeuklarhed*, blefaritis, øjensmerter *, fotopsi*, konjunktivalblødning* konjunktival hyperæmi*
English: Patients of less than 45 years of age with macular oedema following Retinal Vein Occlusion or inflammation of the posterior segment of the eye presenting as non-infectious uveitis are more likely to experience increases in IOP.
Danish: Patienter under 45 år med maculaødem efter retinal veneokklusion eller inflammation i øjets posteriore segment i form af ikke-infektiøs uveitis har større risiko for at få forhøjet intraokulært tryk.
English: Of these, a total of 77 were randomised to receive OZURDEX, 76 to dexamethasone 350 µg and 76 to sham.
Danish: Af disse patienter blev i alt 77 randomiseret til at få OZURDEX, 76 til at få dexamethason 350 µg og 76 til at få sham.
English: One intravitreal implant in applicator.
Danish: Et intravitrealt implantat i applikator.
English: You may hear a ‘click' during the injection of OZURDEX; this is normal.
Danish: Der høres muligvis et klik under injektionen med OZURDEX.
English: Slowly press the actuator button until an audible click is noted.
Danish: Tryk langsomt på udløserknappen, indtil der høres eller fornemmes et klik.
English: A total of 351 were randomised to OZURDEX, 347 to dexamethasone 350 µg and 350 patients to sham.
Danish: I alt 351 patienter blev randomiseret til OZURDEX, 347 til dexamethason 350 µg og 350 til sham.
English: Disposable injection device, containing a rod-shaped implant.
Danish: Injektionssprøjte til engangsbrug, der indeholder et stavformet implantat, som ikke er synligt.
English: Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex and not be used in active ocular herpes simplex.
Danish: Kortikosteroider skal gives med forsigtighed til patienter med okulær virusinfektion (f.eks. med herpes simplex) i anamnesen og må ikke gives til patienter med aktiv okulær herpes simplex.
English: Acid terminated 50:50 poly D,L-lactide-co-glycolide.
Danish: • Syretermineret 50:50 poly D,L-lactid-co-glycolid.
English: • macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) (see section 5.1)
Danish: • maculaødem efter enten retinal grenveneokklusion (BRVO) eller retinal centralveneokklusion (CRVO) (se pkt.
English: A total of 427 were randomised to OZURDEX, 414 to dexamethasone 350 µg and 426 patients to sham.
Danish: I alt 427 patienter blev randomiseret til OZURDEX, 414 til dexamethason 350 µg og 426 til sham.
English: Mean BCVA change from baseline at year 3/Final visit OCT retinal thickness at center subfield mean average change over 3 years, AUC approach (µm)
Danish: Middelændring i BCVA fra baseline ved år 3/afsluttende besøg (bogstaver) Middel af gennemsnitlig ændring i OCT retinal tykkelse på det centrale delfelt (OCT) over 3 år, AUC- metode (µm)
English: Package leaflet: information for the user OZURDEX 700 micrograms intravitreal implant in applicator dexamethasone
Danish: IInformation til brugeren OZURDEX 700 mikrogram intravitrealt implantat i applikator dexamethason
English: In the 3 year DME clinical studies, 59% of patients with a phakic study eye treated with OZURDEX underwent cataract surgery in the study eye (see section 4.8).
Danish: I de 3-årige kliniske studier med DME gennemgik 59 % af patienterne med et fakisk forsøgsøje, der blev behandlet med OZURDEX, en kataraktoperation i forsøgsøjet (se pkt.
English: • macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO)
Danish: • maculaødem efter enten retinal grenveneokklusion (BRVO) eller retinal centralveneokklusion (CRVO).
English: 5) Withdraw the applicator in the same direction that you used to enter the vitreous.
Danish: 5) Fjern kanylen i samme retning, som den blev indført i corpus vitreum.
English: Table 4.
Danish: Tabel 4 .
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ€
English: A severe inflammation at the back of the eye (usually due to viral infection), serious infection or inflammation inside the eye*, glaucoma (an eye disease in which increased pressure in the eye is associated with damage to the optic nerve), detachment of the light-sensitive layer from the back of the eye* (retinal detachment), tear of the light-sensitive layer at the back of the eye (retinal tear)*, a decrease in the eye pressure which is associated with leakage of the jelly (vitreous) from inside the eye*, inflammation inside the front part of the eye*, increased protein and cells in the front of the eye due to inflammation*,
Danish: Alvorlig betændelse i det bageste af øjet (som regel på grund af virusinfektion), alvorlig betændelse eller inflammation i øjet*, grøn stær (øjensygdom, hvor forhøjet tryk i øjet er forbundet med skade på synsnerven), løsrivelse af det lysfølsomme lag bagest i øjet* (nethindeløsning), rift i det lysfølsomme lag i bagest i øjet (rift i nethinden)*, fald i trykket i øjet forbundet med udsivning fra det geleagtige legeme (glaslegemet) i det indre øje*, inflammation i det indre af den forreste del af øjet*, forhøjet protein og celler i den forreste del af øjet på grund af inflammation*, unormal fornemmelse i øjet*, kløe i øjenlåget, rødme i det hvide af øjet*, migration (”vandring”) af OZURDEX-implantatet fra det bageste til det forreste af øjet med sløret eller forringet syn og muligvis hævelse af den klare del af øjet (hornhinden) til følge*, utilsigtet forkert placering af OZURDEX-implantatet*, migræne
English: Among patients who used anti-coagulant therapy, the frequency of haemorrhagic adverse events was similar in the OZURDEX and sham groups (29% vs 32%).
Danish: Blandt de patienter, der fik antikoagulantia, var hyppigheden af blødningshændelser omtrent den samme i OZURDEX gruppen som i gruppen, der fik sham (29 % versus 32 %).
English: Vitreous Haze Score of Zero BCVA improvement from baseline of ≥15 letters
Danish: Score for glaslegemeuklarhed på 0 BCVA-forbedring fra baseline på
English: - Each implant contains 700 micrograms of dexamethasone.
Danish: - Hvert implantat indeholder 700 mikrogram dexamethason.
English: Proportion of patients with vitreous haze score of zero and ≥ 15 letters improvement from baseline best corrected visual acuity in the study eye (ITT population)
Danish: Andelen af patienter med en score for glaslegemeuklarhed på 0 og en forbedring i forsøgsøjet på ≥ 15 bogstaver fra BCVA ved baseline (ITT-population)
English: Necrotizing retinitis, endophthalmitis*, glaucoma, retinal detachment*, retinal tear*, hypotony of the eye*, anterior chamber inflammation*, anterior chamber cells/ flares*, abnormal sensation in eye*, eyelids pruritus, scleral hyperaemia*
Danish: Ikke almindelig Nekrotiserende retinitis, endoftalmitis*, glaukom, retinaløsning*, retinarift*, hypotoni i øjet*, inflammation i forkammeret*, forkammerceller/lysglimt*, unormal fornemmelse i øjet*, øjenlågskløe, sclerahyperæmi*
English: Ester terminated 50:50 poly D,L-lactide-co-glycolide.
Danish: • Estertermineret 50:50 poly D,L-lactid-co-glycolid.
English: There continued to be a numerically greater proportion of responders for a ≥ 15 letter improvement from baseline in BCVA in patients treated with OZURDEX compared with sham at day 180.
Danish: bogstaver fra baseline i BCVA hos patienter, der blev behandlet med OZURDEX, sammenlignet med sham på dag 180.
English: Therefore OZURDEX is not recommended.
Danish: Derfor frarådes behandling med OZURDEX.
English: OZURDEX 700 micrograms intravitreal implant in applicator dexamethasone
Danish: OZURDEX 700 mikrogram intravitrealt implantat i applikator dexamethason
English: One implant contains 700 micrograms of dexamethasone.
Danish: Et implantat indeholder 700 mikrogram dexamethason.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om navn, skal du henvende dig til den lokale repræsentant:
English: CARTON AND POUCH EXTENDED LABEL
Danish: UDVIDET MÆRKNING PÅ ÆSKE OG POSE
English: OCT retinal thickness at center subfield mean average change over 3 years, AUC approach (µm)
Danish: Middel af gennemsnitlig ændring i retinal tykkelse på det centrale delfelt (OCT) over 3 år, AUC metode (µm)
English: Therefore administration to both eyes concurrently is not recommended.
Danish: Det frarådes derfor at behandle begge øjne samtidigt.
English: Pharmacotherapeutic group: Ophthalmologicals, antiinflammatory agents, ATC code: S01BA01
Danish: Farmakoterapeutisk klassifikation: Ophthalmologica, antiinflammatoriske stoffer.
English: Device dislocation* (migration of implant) with or without corneal oedema (see also section 4.4), complication of device insertion resulting in ocular tissue injury* (implant misplacement)
Danish: Ikke almindelig Migration af implantat* med eller uden corneaødem (se også pkt.
English: One implant contains 700 micrograms of dexamethasone
Danish: Et implantat indeholder 700 mikrogram dexamethason
English: How to store OZURDEX
Danish: Sådan får du OZURDEX
English: Mean BCVA average change over 3 years, AUC approach (letters)
Danish: Middel af gennemsnitlig ændring i BCVA (Best Corrected Visual Acuity) i løbet af 3 år, AUC (Area Under the Curve)-metode (bogstaver)
English: Mean BCVA change from baseline at year 3/Final visit
Danish: Middelændring i BCVA fra baseline ved år 3/afsluttende besøg (bogstaver)
English: Sham N = 261 P-value
Danish: Sham N = 261
English: Sham N = 101 P-value
Danish: Sham N = 101
English: Increased pressure in the eye, clouding of the lens (cataract), bleeding on the surface of the eye*
Danish: Meget almindelige (kan forekomme hos mere end 1 ud af 10 behandlede): Forhøjet tryk i øjet, uklarheder i øjets linse (grå stær), blødning på øjets overflade*
English: Hepatic impairment
Danish: Diabetisk maculaødem
English: Proportion of patients with ≥ 15 letters improvement from baseline best corrected visual acuity in the study eye (pooled, ITT population)
Danish: Andel af patienter med en forbedring på ≥ 15 bogstaver fra baseline i BCVA (Best
English: - The other ingredients are: Ester terminated 50:50 poly D,L-lactide-co-glycolide and
Danish: - Øvrige indholdsstoffer: estertermineret 50:50 poly D,L-lactid-co-glycolid og syretermineret 50:50 poly D,L-lactid-co-glycolid.
English: If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used.
Danish: Applikatoren må ikke bruges, hvis forseglingen på folieposen er beskadiget.
English: In RVO, anti-coagulant therapy was used in 2% of patients receiving OZURDEX; there were no reports of haemorrhagic adverse events in these patients.
Danish: Ved RVO blev 2 % af de patienter, som fik OZURDEX, behandlet med antikoagulantia.
English: The rise in IOP is normally manageable with IOP lowering medication (see section 4.8).
Danish: Stigningen i intraokulært tryk kan normalt håndteres med medicin, der sænker det intraokulære tryk (se pkt.
English: The safety and efficacy of OZURDEX in uveitis in the paediatric population have not been established.
Danish: OZURDEX' sikkerhed og virkning hos børn og unge med uveitis er ikke klarlagt.
English: Method of administration OZURDEX is a single-use intravitreal implant in applicator for intravitreal use only.
Danish: Administration Intravitrealt implantat i applikator til engangsbrug, kun til intravitreal anvendelse.
English: LIST OF EXCIPIENTS
Danish: ETIKET PÅ APPLIKATOR
English: The most common haemorrhagic adverse event reported was conjunctival haemorrhage (up to 24%).
Danish: De hyppigst rapporterede uønskede blødningshændelser var konjunktivalblødning (op til
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,
English: ATC code: A10A C01.
Danish: ATC-kode: A10A C01.
English: However, the Monotard dosage may need to be adjusted.
Danish: Imidlertid skal Monotard-dosis måske justeres.
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: ANDRE BETINGELSER Indehaveren af denne markedsføringstilladelse skal underrette Europa-Kommissionen om markedsføringsplanerne for det lægemiddel, der er godkendt ved denne beslutning.
English: Like all medicines, Monotard can have side effects.
Danish: Som alle andre lægemidler kan Monotard have bivirkninger.
English: Trials have indicated a t½ of about 9-15 hours.
Danish: Forsøg har indikeret en t½ på ca. 9 - 15 timer.
English: Repeat this procedure if necessary until the liquid is uniformly white and cloudy
Danish: Gentag denne procedure om nødvendigt indtil væsken er ensartet hvid og uklar
English: The listings below are all based on post-marketing experience and is subject to underreporting and should be interpreted in that light.
Danish: Nedenstående liste er baseret på post-marketing erfaring og repræsenterer en underrapportering og bør tolkes under hensyntagen hertil.
English: MARKETING AUTHORISATION NUMBERS EU/0/00/000/000
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/0/00/000/000
English: From clinical investigations it is known that major hypoglycaemia, defined as need for assistance in treatment, occurs in approximately 20% of well-controlled patients.
Danish: Kliniske undersøgelser viser, at svær hypoglykæmi, defineret som behov for hjælp under behandlingen, optræder hos ca. 20% velkontrollerede patienter.
English: Do not use Monotard after the expiry date stated on the label and the carton.
Danish: Monotard må ikke anvendes efter den udløbsdato, der er angivet på etiketten og kartonen.
English: Usual warning symptoms may disappear in patients with longstanding diabetes.
Danish: De sædvanlige advarselssymptomer kan forsvinde hos patienter med langvarig diabetes.
English: You may have a very rare serious allergic reaction to Monotard or one of its ingredients (called a systemic allergic reaction).
Danish: De kan have fået en meget sjælden, alvorlig allergisk reaktion på Monotard eller et af de øvrige indholdsstoffer (også kaldet systemisk allergisk reaktion).
English: Monotard contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Danish: Monotard indeholder methylparahydroxybenzoat, som kan forårsage allergiske reaktioner (evt. forsinkede).
English: Based on post-marketing experience adverse drug reactions including hypoglycaemia have been reported rarely (>1/10,000 <1/1,000).
Danish: Baseret på post-marketing erfaring er en bivirkning, herunder hypoglykæmi, sjældent rapporteret (>1/10.000 <1/1.000).
English: Do not store above 25°C.
Danish: Må ikke opbevares ved over 25°C.
English: See also the warning in 2 Before you use Monotard.
Danish: Se også advarslen i 2 Hvad De skal gøre, før De begynder at tage Monotard.
English: This means that it will start to lower your blood sugar about 2 ½ hours after you take it, and the effect will last for approximately 24 hours.
Danish: Det betyder, at det begynder at nedsætte blodsukkeret ca. 2½ timer efter injektion, og at virkningen holder i ca. 24 timer.
English: Onset of action is within 2½ hours, reaches a maximum effect within 4-15 hours and the entire time of duration is approximately 24 hours.
Danish: Virkningen indtræder inden for 2½ time, maksimal virkning opnås 4 - 15 timer senere, og virkningsvarigheden er ca. 24 timer.
English: Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Danish: Anden sygdom, især infektioner og tilstande med feber, vil normalt øge patientens insulinbehov.
English: Monotard is for injection under the skin (subcutaneously).
Danish: Monotard er beregnet til injektion under huden (subkutant).
English: Pharmacotherapeutic group: antidiabetic agent.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika.
English: In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals.
Danish: Ved intensiv insulinbehandling kan suspensionen anvendes som basal insulin (injektion aften og/eller morgen) med hurtigtvirkende insulin til måltiderne.
English: Do not use Monotard ► If the protective cap is loose or missing.
Danish: De bør ikke anvende Monotard ► Hvis beskyttelseskapslen er løs eller mangler.
English: • Inject the mixture straight away.
Danish: Injicér blandingen straks.
English: In pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg.
Danish: Hos præpubertale børn vil det ofte variere mellem 0,7 og 1,0 IE/kg.
English: • If you take too much insulin
Danish: Dette kan ske: Hvis De tager for meget insulin
English: • Inject the insulin under the skin.
Danish: Injicér insulinet under huden.