FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions considered related to OZURDEX treatment from the Phase III clinical trials (DME, BRVO/CRVO and uveitis) and spontaneous reporting are listed by MedDRA System organ class in the table below using the following convention:
Danish: Bivirkninger fra de kliniske fase III-studier (DME, BRVO/CRVO og uveitis), der anses for at være relateret til OZURDEX-behandling, samt fra spontane indberetninger er opstillet efter MedDRAsystemorganklasse i nedenstående tabel ved brug af følgende konvention:
English: Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile tray.
Danish: Åbn derefter folieposen i et sterilt felt, og anbring forsigtigt applikatoren på en steril bakke.
English: The efficacy of OZURDEX was assessed in two multicentre, double-masked, randomised, sham-controlled, parallel studies of identical design which together comprised 1,267 patients who were randomized to receive treatment with dexamethasone 350 µg or 700 µg implants or sham (studies 206207-008 and 206207-009).
Danish: Virkningen af OZURDEX blev vurderet i to multicenter-, dobbeltblindede, randomiserede, shamkontrollerede, parallelle studier med identisk design, der tilsammen omfattede 1.267 patienter, som var randomiseret til at få behandling med dexamethason 350 µg eller 700 µg implantater eller sham (studie 206207-008 og 206207-009).
English: The clinical efficacy of OZURDEX has been assessed in a single, multicentre, masked, randomised study for the treatment of non-infectious ocular inflammation of the posterior segment in patients with uveitis.
Danish: OZURDEX' kliniske effekt er blevet undersøgt i et maskeret, randomiseret multicenterstudie til behandling af ikke-infektiøs okulær inflammation af det posteriore segment hos patienter med uveitis.
English: • Key signs and symptoms of serious adverse events including: worsening of vision after the injection; pain or discomfort in or around the eye, redness of the eye which continues to get worse; increase in floaters or spots in the vision; discharge from the eye
Danish: • Vigtige tegn og symptomer på alvorlige bivirkninger, forringelse af synet efter injektionen, smerter eller ubehag i eller omkring øjet, rødme i øjet, som fortsat tager til, øgning af mouches volantes
English: Ninety-five percent of the plasma dexamethasone concentration values for the 350 µg dose group and 86% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL).
Danish: 95 % af værdierne for dexamethasons plasmakoncentration for 350 µg-dosisgruppen og 86 % for 700 µg-dosisgruppen var under den nedre kvantificeringsgrænse (0,05 ng/ml).
English: - if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6) - if you have an infection of any kind in or around your eye (bacterial, viral or fungal) - if you have glaucoma or high pressure inside your eye which is not controlled properly with the medicines you may be using - if the eye to be treated does not have a lens and the back of the lens capsule (“the bag”) has been ruptured
Danish: - hvis du er overfølsom (allergisk) over for dexamethason eller et af de øvrige indholdsstoffer i OZURDEX (angivet i afsnit 6) - hvis du har en infektion i eller omkring øjet (bakterie, virus eller svamp) - hvis du har glaukom eller et højt tryk i øjet, som ikke er velkontrolleret med den medicin, du tager - hvis det øje, der skal behandles, ikke har en linse, og bagsiden af linsekapslen (”sækken”) er bristet
English: Based on the pooled analysis results, treatment with OZURDEX implants showed statistically significantly greater incidence of responders, defined as patients achieving a ≥ 15 letter improvement from baseline in Best Corrected Visual Acuity (BCVA) at 90 days following injection of a single implant, when compared with sham (p < 0.001).
Danish: På baggrund af den puljede analyse udviste behandlingen med OZURDEX-implantater en væsentlig større forekomst af respondenter, defineret som patienter, som opnår en forbedring på ≥ 15 bogstaver fra baseline i BCVA (Best Corrected Visual Acuity) efter 90 dage efter injektion af et enkelt implantat sammenlignet med sham (p < 0,001).
English: A total of 427 patients were randomised to receive OZURDEX and 426 to receive sham in the two Phase III studies.
Danish: I alt 427 patienter blev randomiseret til at få OZURDEX og 426 til at få sham i de to fase III-studier.
English: In each of the phase III studies and the pooled analysis, mean retinal thickness was significantly less, and the mean reduction from baseline was significantly greater, with OZURDEX (-207.9 microns) compared to sham (-95.0 microns) at day 90 (p < 0.001, pooled data).
Danish: I hvert af fase III-studierne og den puljede analyse var middeltykkelsen af retina væsentlig mindreog middelreduktionen fra baseline var væsentlig større - med OZURDEX (-207,9 mikrometer) sammenlignet med sham (-95,0 mikrometer) på dag 90 (p < 0,001, puljede data).
English: Pooled Studies 206207-010 and
Danish: Puljede studier 206207-010 og
English: Intravitreous injections, including those with OZURDEX, can be associated with endophthalmitis, intraocular inflammation, increased intraocular pressure and retinal detachment.
Danish: Intravitreale injektioner, herunder injektioner med OZURDEX, kan være forbundet med endoftalmitis, intraokulær inflammation, forhøjet intraokulært tryk og nethindeløsning.
English: The most frequently reported adverse reactions in the study eye of patients who received OZURDEX were conjunctival haemorrhage (30.3%), increased intraocular pressure (25.0%) and cataract (11.8%).
Danish: De hyppigst indberettede bivirkninger i forsøgsøjet på patienter, der fik OZURDEX, var konjunktivalblødning (30,3 %), forhøjet intraokulært tryk (25,0 %) og katarakt (11,8 %).
English: As for the initial treatment, peak response was seen at Day 60 in the open label phase.
Danish: Som i den indledende behandling blev maksimal respons opnået på dag 60 i den ikke-blindede fase.
English: • Vision loss due to diabetic macular oedema (DME), if you have already had an operation for cataract, or if you have not previously responded to, or are not suitable for, other types of treatment.
Danish: • Synstab som følge af diabetisk maculaødem (DME), hvis du er blevet opereret for grå stær, eller hvis du tidligere ikke har reageret på eller ikke er egnet til andre typer behandling.
English: Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application.
Danish: Dexamethason har vist sig at have teratogene virkninger hos mus og kaniner efter oftalmisk anvendelse.
English: Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see section 4.8).
Danish: Patienter kan opleve midlertidigt nedsat syn efter indgivelse af OZURDEX via intravitreal injektion (se pkt.
English: A total of 229 patients were randomised to receive dexamethasone 350 µg or 700 µg implants or sham.
Danish: I alt 229 patienter blev randomiseret til at få dexamethason-implantat på 350 µg eller 700 µg eller sham.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH AND OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Efficacy in studies 206207-010 and 206207-011 (ITT population)
Danish: Virkning i studierne 206207-010 og 20607-11 (ITT-population)
English: - The active substance is dexamethasone.
Danish: - Aktivt stof: Dexamethason.
English: • visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy
Danish: • synsforringelse som følge af diabetisk maculaødem (DME), som er pseudofake, eller som vurderes ikke at opnå tilstrækkelig respons med, eller som er uegnede til ikke-kortikosteroid behandling
English: OZURDEX is a rod-shaped implant which is stored inside the needle of an applicator.
Danish: OZURDEX er et stavformet implantat, som er placeret i nålen på en applikator.
English: • What are the steps following treatment with OZURDEX
Danish: • Information om, hvilke trin der er i forbindelse med behandling med OZURDEX
English: The percent of patients requiring escape medications from baseline to week 8 was nearly 3-fold less with OZURDEX (7.8%) compared to Sham (22.4%), p = 0.012.
Danish: Procentdelen af patienter, der havde behov for rescue-medicin fra baseline til uge 8, var næsten 3 gange mindre med OZURDEX (7,8 %) end med sham (22,4 %) p = 0,012.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 behandlede):
English: One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator.
Danish: En fyldt sprøjte med sterilt implanterbart, stavformet implantat indeholdende 700 mikrogram dexamethason anbragt i nålen (rustfrit stål) i en applikator til engangsbrug.
English: - if the eye to be treated has undergone cataract surgery and has a man-made lens, which was implanted in the front compartment of the eye (anterior chamber intraocular lens) or was fixed to the white portion of the eye (sclera) or to the coloured part of the eye (iris), and the back of the lens capsule (“the bag”) has been ruptured
Danish: - hvis det øje, der skal behandles, er blevet opereret for grå stær og har en kunstig linse, som er blevet implanteret i øjets forkammer (forkammerlinse) eller blev fastgjort til den hvide del af øjet (sclera) eller til den farvede del af øjet (iris), og bagsiden af linsekapslen (”sækken”) er bristet
English: Plasma concentrations were obtained from a subgroup of patients in the two DME pivotal studies prior to dosing and on days 1, 7, and 21, and months 1.5 and 3 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone.
Danish: Plasmakoncentrationer blev indhentet fra en undergruppe af patienterne i de to pivotale DMA-studier før dosering og på dag 1, 7 og 21 og måned 1,5 og 3 efter intravitreal injektion af et enkelt intravitrealt implantat indeholdende 350 µg eller 700 µg dexamethason.
English: The European Medicines Agency has waived the obligation to submit the results of studies with OZURDEX in all subsets of the paediatric population for retinal vascular occlusion and also for diabetic macular oedema (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med OZURDEX hos alle undergrupper af den pædiatriske population for retinal vaskulær okklusion og for diabetisk maculaødem.
English: Use of corticosteroids, including OZURDEX, may induce cataracts (including posterior subcapsular cataracts), increased IOP, steroid induced glaucoma and may result in secondary ocular infections.
Danish: Kortikosteroider, herunder OZURDEX, kan inducere katarakt (herunder posteriort subkapsulært katarakt), forhøjet intraokulært tryk og glaukom og kan resultere i sekundære øjeninfektioner.
English: What you need to know before you are given OZURDEX You must not be given OZURDEX
Danish: Det skal du vide, før du får OZURDEX Brug ikke OZURDEX
English: OZURDEX has not been studied in patients with macular oedema secondary to RVO with significant retinal ischemia.
Danish: OZURDEX er ikke blevet undersøgt hos patienter med maculaødem sekundært til retinal veneokklusion (RVO) med signifikant retinal iskæmi.
English: Before withdrawing the applicator from the eye, make sure that the actuator button is fully pressed and has locked flush with the applicator surface.
Danish: Inden applikatoren fjernes fra øjet, skal det sikres, at udløserknappen er trykket helt ned og fastlåst i niveau med applikatoroverfladen.
English: The most frequently reported adverse reactions across the entire study period in the study eye of patients who received OZURDEX were cataract and elevated IOP (see below).
Danish: De hyppigst indberettede bivirkninger i hele studieperioden i forsøgsøjet hos de patienter, der fik OZURDEX, var katarakt og forhøjet intraokulært tryk (se nedenfor).
English: Remove the foil pouch from the carton and examine for damage (see section 6.6).
Danish: Tag pakningen ud af folieposen, og efterse den for skader (se pkt.
English: Please tell your doctor immediately if you develop increased eye pain or increased discomfort, worsening redness of your eye, flashing lights and sudden increase in floaters, partially blocked vision, decreased vision or increased sensitivity to light after your injection.
Danish: Kontakt straks lægen, hvis du efter injektionen får flere øjensmerter, øget ubehag eller forværring af rødme i øjet, oplever lysglimt og pludseligt ser flere ”flyvende fluer” (pletter), får delvist blokeret syn, nedsat syn eller øget følsomhed over for lys.
English: One hundred percent of the plasma dexamethasone concentration values for the 350 µg dose group and 90% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL).
Danish: Alle de målte dexamethasonkoncentrationer i plasma for 350 µg-dosisgruppen og 90 % for 700 µg-dosisgruppen var under den nedre kvantificeringsgrænse (0,05 ng/ml).
English: Very common Intraocular pressure increased**, cataract**, conjunctival haemorrhage*
Danish: Meget almindelig Forhøjet intraokulært tryk**, katarakt**, konjunktival blødning*
English: The highest plasma concentration value of 0.094 ng/mL was observed in one subject from the 700 µg group.
Danish: Den højeste koncentration i plasma på 0,094 ng/ml blev observeret hos én forsøgsperson i 700 µg-gruppen.
English: • Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: However OZURDEX is not recommended during breast feeding unless clearly necessary.
Danish: OZURDEX anbefales dog ikke til ammende kvinder, medmindre det er klart nødvendigt.
English: The applicator containing the implant is packaged in a sealed foil pouch containing desiccant.
Danish: Applikatoren, der indeholder implantatet, er pakket i en forseglet foliepose med et tørremiddel.
English: For patients using concomitant and anti-platelet medication, haemorrhagic adverse events were reported in a slightly higher proportion of patients injected with OZURDEX (up to 29%) compared with the sham group (up to 23%), irrespective of indication or number of treatments.
Danish: For patienter, der fik samtidige trombocytfunktionshæmmende lægemidler, blev der indberettet uønskede blødningshændelser hos en lidt højere andel i OZURDEXgruppen (op til 29 %) sammenlignet med sham-gruppen (op til 23 %), uanset indikation og antal behandlinger.
English: Remove the needle in the same direction as used to enter the vitreous.
Danish: Fjern nålen i samme retning, som da den blev indført i corpus vitreum.
English: OZURDEX is for single use only.
Danish: OZURDEX er kun til engangsbrug.
English: The highest plasma concentration value of 0.102 ng/mL was observed in 1 subject from the 700 µg group.
Danish: Den højeste plasmakoncentration på 0,102 ng/ml blev observeret hos en forsøgsperson i 700 µg-gruppen.
English: OZURDEX has not been studied in patients with renal impairment however no special considerations are needed in this population.
Danish: OZURDEX er ikke blevet undersøgt hos patienter med nedsat leverfunktion, men der er dog ikke behov for særlige hensyn til denne population.
English: In the 3 year DME clinical studies, at baseline, 87% of patients with a phakic study eye treated with OZURDEX had some degree of lens opacification/ early cataract.
Danish: I de 3-årige kliniske studier med DME havde 87 % af de patienter med et fakisk forsøgsøje, som blev behandlet med OZURDEX, nogen grad af linseopacificering/tidlig katarakt ved baseline.
English: Plasma concentrations were obtained from a subset of 21 patients in the two RVO, 6-month efficacy studies prior to dosing and on days 7, 30, 60 and 90 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone.
Danish: Der blev målt plasmakoncentrationer hos en undergruppe på 21 patienter i de to, 6-måneders RVOeffektstudier før indgivelse og på dag 7, 30, 60 og 90 efter intravitreal injektion af et enkelt intravitrealt implantat med 350 µg eller 700 µg dexamethason.
English: Advance the needle until you enter the vitreous cavity.
Danish: Før kanylen frem, indtil den er inde i corpus vitreum.
English: Patients must be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay, e.g. eye pain, blurred vision etc. (see section 4.8).
Danish: Patienterne skal informeres om straks at rapportere eventuelle symptomer, der kan være tegn på endoftalmitis eller en eller flere af ovennævnte hændelser, f.eks. øjensmerter, sløret syn osv. (se pkt.
English: OZURDEX is a single-use intravitreal implant in applicator for intravitreal use only.
Danish: OZURDEX er et intravitrealt implantat i applikator til engangsbrug, kun til intravitreal anvendelse.
English: Patients who had a BCVA score of <84 OR retinal thickness > 250 microns by optical coherence tomography OCT and in the investigator's opinion treatment would not put the patient at risk; were eligible to receive an OZURDEX treatment in an open label extension.
Danish: Patienter med en BCVA-score på < 84 ELLER en retinatykkelse på > 250 mikrometer ved OCT (Optical Coherence Tomography), og hvor behandling efter investigators skøn ikke ville udsætte patienten for risici, blev fundet egnede til at modtage OZURDEX-behandling i en ikke-blindet forlængelsesfase.
English: Do not use if foil pouch seal is damaged.
Danish: Må ikke bruges, hvis forseglingen af folieposen er beskadiget.
English: The safety and efficacy of OZURDEX administered to both eyes concurrently have not been studied.
Danish: Sikkerheden og virkningen af OZURDEX, der indgives i begge øjne samtidigt, er ikke blevet undersøgt.
English: which is not visible.
Danish: som ikke er nævnt her.
English: Anti-platelet medicinal products, such as clopidogrel, were used at some stage during the clinical studies in up to 56% of patients.
Danish: Op til 56 % af patienterne fik trombocytfunktionshæmmende lægemidler, f.eks. clopidogrel, på et tidspunkt under de kliniske studier.
English: • diabetic macular oedema
Danish: • diabetisk maculaødem
English: Vitreous haemorrhage was reported in a higher proportion of patients treated with OZURDEX who received anti-coagulant therapy (11%) compared with those not receiving anticoagulant therapy (6%).
Danish: I OZURDEXgruppen blev blødning i glaslegemet indberettet hos en højere andel af patienter, der fik antikoagulantia (11 %) sammenlignet med patienter, der ikke fik antikoagulantia (6 %).
English: Efficacy in pseudophakic patients (pooled studies 206207-010 and 206207-011)
Danish: Virkning hos pseudofakiske patienter (puljede studier 206207-010 og 206207-011)
English: Corticosteroids should be used cautiously in patients with a history of ocular viral (e.g. herpes simplex) infection and not be used in active ocular herpes simplex.
Danish: Kortikosteroider skal gives med forsigtighed til patienter med okulær viral (f.eks. herpes simplex) infektion i anamnesen og må ikke gives til patienter med aktiv okulær herpes simplex.
English: • Inflammation of the back of the eye.
Danish: • Inflammation (irritation / betændelse) bagerst i øjet.
English: Day 60
Danish: Dag 60
English: Among patients who did not use anti-coagulant therapy, 27% of OZURDEX treated patients reported haemorrhagic adverse events compared to 20% in the sham group.
Danish: Blandt de patienter, der ikke fik antikoagulantia, indberettede 27 % af de patienter, der blev behandlet med OZURDEX, uønskede blødningshændelser sammenlignet med 20 % i sham-gruppen.
English: Immediately after injecting OZURDEX, use indirect ophthalmoscopy in the quadrant of injection to confirm successful implantation.
Danish: Anvend indirekte oftalmoskopi i injektionskvadranten straks efter injektionen af OZURDEX for at kontrollere, at implanteringen lykkedes.
English: Before your OZURDEX injection tell your doctor if: - You have had cataract surgery, iris surgery (the coloured part of the eye that controls the amount of light that enters into the eye) or surgery to remove the gel (called the vitreous) from within the eye - You are taking any medicines to thin the blood - You are taking any steroid or non-steroidal anti-inflammatory medicines by mouth or applied to the eye - You have had a herpes simplex infection in your eye in the past (an ulcer on the eye that has been there a long time, or sores on the eye)
Danish: Kontakt lægen, før din OZURDEX-injektion, hvis: - du er blevet opereret for grå stær (katarakt), opereret i regnbuehinden (den farvede del af øjet, som bestemmer, hvor meget lys der kommer ind i øjet), eller har fået fjernet glaslegemet inde i øjet - du tager blodfortyndende medicin - du tager steroider eller ikke-steroide antiinflammatoriske (inflammationshæmmende) lægemidler gennem munden eller i øjet - du tidligere har haft en herpes simplex-infektion i øjet (et sår i øjet, der har været der i lang tid, eller smerter i øjet)
English: The most frequently reported adverse reactions in patients who received OZURDEX were increased intraocular pressure (24.0 %) and conjunctival haemorrhage (14.7 %).
Danish: De hyppigst rapporterede bivirkninger hos patienter, som fik OZURDEX, var forhøjet intraokulært tryk (24,0 %) og konjunktivalblødning
English: Whereas, delaying treatment for 6 months results in a lower proportion of responders at all time points in the open label phase when compared with those receiving a second OZURDEX injection.
Danish: Derimod medførte en 6-måneders udsættelse af behandlingen en lavere andel deltagere, der reagerede på behandlingen, på alle tidspunkter i den ikke-blindede fase, sammenlignet med de patienter, som fik endnu en OZURDEX-injektion.
English: If this happens, do not drive or use any tools or machines until your vision improves.
Danish: Kør ikke bil eller motorcykel, og lad være med at cykle, hvis dette sker, og indtil dit syn har forbedret sig.
English: Diabetic macular oedema is a swelling of the light-sensitive layer at the back of the eye called the macula.
Danish: Ved diabetisk maculaødem er det lysfølsomme lag bagerst i øjet, som kaldes macula, hævet.
English: BCVA ≥ 15-letter improvement from baseline at Year 3/Final (%) P-value
Danish: BCVA ≤ 15 bogstaver forbedring fra baseline i år 3/afslutning (%) P-værdi
English: A total of 77 patients were randomised to receive OZURDEX and 76 to receive Sham.
Danish: I alt 77 patienter blev randomiseret til at få OZURDEX og 76 patienter til at få sham.
English: 3) Redirect towards the centre of the eye into the vitreous cavity.
Danish: 3) Ret derefter kanylen ind mod midten af øjet til corpus vitreum.
English: At baseline 3% of patients required IOP-lowering medication(s).
Danish: Ved baseline havde 3 % af patienterne behov for medicin til sænkning af det intraokulære tryk.
English: The proportion of patients with vitreous haze score of 0 in the study eye at week 8 (primary endpoint) was 4-fold higher with OZURDEX (46.8%) compared to Sham (11.8%), p < 0.001.
Danish: Andelen af patienter med en score for glaslegemeuklarhed på 0 i forsøgsøjet efter 8 uger (primært endepunkt) var 4 gange højere efter behandling med OZURDEX (46,8 %) sammenlignet med sham (11,8 %) (p < 0,001).
English: In addition, patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs.
Danish: Derudover skal patienterne overvåges efter injektionen, så der kan iværksættes tidlig behandling ved forekomst af infektion eller forhøjet intraokulært tryk (IOP).
English: The clinical safety of OZURDEX in patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis, has been assessed in a single, multicentre, masked, randomised study.
Danish: OZURDEX' kliniske sikkerhed hos patienter med inflammation i øjets posteriore segment, der viser sig som ikke-infektiøs uveitis, er blevet undersøgt i et maskeret, randomiseret multicenterstudie.