FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical study in patients scheduled for vitrectomy receiving 0.125 mg JETREA (corresponding to a theoretical start concentration of 29 µg/mL vitreous), mean ocriplasmin activity was 9% of theoretical start concentration 2-4 hours after injection and below the lower level of quantification at 7 days.
Danish: I et klinisk studie hos patienter, som var planlagt til vitrektomi, og som fik 0,125 mg Jetrea (svarende til en teoretisk startkoncentration på 29 µg/ml glaslegeme), var den gennemsnitlige ocriplasmin-aktivitet 9 % af teoretisk startkoncentration 2-4 timer efter injektion og under det nedre kvantificeringsniveau efter 7 dage.
English: What you need to know before you are given Jetrea You must not be given Jetrea
Danish: Det skal du vide, før du begynder at få Jetrea Du må ikke få Jetrea
English: The patient had a decrease in BCVA of 21 ETDRS letters from baseline that returned to within 9 letters of baseline at the end of the study.
Danish: Patienten oplevede et fald i bedst korrigerede visus (BCVA) på 21 ETDRS-bogstaver i forhold til baseline, som reduceredes til et fald på 9 ETDSR-bogstaver i forhold til baseline ved studiets afslutning.
English: The proportion of patients who underwent vitrectomy was smaller in the JETREA group than in the sham group at all visits.
Danish: Andelen af patienter, som fik foretaget vitrektomi, var mindre i Jetrea-gruppen end i placebogruppen ved alle besøg.
English: In this study, FTMH was present at baseline in 50/145 (34.5%) and 26/73 (35.6%) patients in the JETREA and sham groups, respectively.
Danish: I dette studie var FTMH til stede ved baseline hos henholdsvis 50/145 (34,5 %) og 26/73 (35,6 %) af patienterne i Jetrea- og placebogrupperne.
English: 3 years when stored in a freezer (-20 °C ± 5 °C).
Danish: 3 år ved opbevaring i fryser (-20 °C ± 5 °C).
English: Ocriplasmin levels in the vitreous decrease rapidly after intravitreal administration.
Danish: Ocriplasmin-koncentrationer i glaslegemet falder hurtigt efter intravitreal administration.
English: Jetrea is given as a single injection into the affected eye.
Danish: Jetrea gives som en enkelt injektion i det berørte øje.
English: The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Danish: Den intravitreale injektionsprocedure skal udføres under kontrollerede aseptiske forhold, hvilket omfatter brug af kirurgisk hånddesinfektion, sterile handsker, et sterilt afdækningsstykke og et sterilt spekulum til øjenlåg (eller tilsvarende) og mulighed for steril paracentese (hvis påkrævet).
English: The safety and efficacy of JETREA administered to both eyes concurrently has not been studied.
Danish: Jetreas sikkerhed og virkning ved samtidig administration i begge øjne er ikke undersøgt.
English: Jetrea is given as an injection into the eye.
Danish: Jetrea gives som en injektion i øjet.
English: At all post-injection days, p≤0.024 in TG-MV-006, p≤0.009 in TG-MV-007, p<0.001
Danish: På alle dage efter injektionen, p ≤ 0,024 i TG-MV-006, p ≤ 0,009 i TG-MV-007, p < 0,001 i integrerede data
English: Do not refreeze a vial once it has been thawed.
Danish: Hætteglasset må ikke fryses igen, når det først har været optøet.
English: • How is Jetrea treatment administered
Danish: • Hvordan Jetrea-behandlingen administreres
English: In the JETREA group, 1 patient (0.7%) developed retinal tear and retinal detachment between Day 0 and Day 7 post-injection.
Danish: I Jetrea-gruppen fik 1 patient (0,7 %) nethinderift og nethindeløsning mellem dag 0 og dag 7 efter injektionen.
English: The remaining sodium chloride 9 mg/mL (0.9%) solution for injection should be discarded.
Danish: Den resterende natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, skal bortskaffes.
English: Once removed from the freezer or refrigerator, the medicinal product may be kept below 25 °C for up to 8 hours.
Danish: Så snart lægemidlet er taget ud af fryseren eller køleskabet, skal det opbevares ved under 25 °C i op til 8 timer.
English: The intravitreal toxicity of ocriplasmin has been evaluated in rabbits, monkeys and minipigs.
Danish: Den intravitreale toksicitet af ocriplasmin er blevet evalueret i kaniner, aber og smågrise.
English: • Summary of Product Characteristics (SmPC) • Information packs for the patients
Danish: • Produktresumé • Indlægsseddel: Information til patienten
English: The effect of ocriplasmin (particularly in inducing resolution of vitreomacular adhesion or causing total posterior vitreous detachment [PVD]) is reduced in subjects with an epiretinal membrane (ERM) or a diameter of VMA > 1500 microns (see section 5.1).
Danish: Virkningen af ocriplasmin (især om det fremkalder en nomalisering af vitreomaculær adhæsion (VMA) eller forårsager total posterior glaslegemeløsning [PVD]) er nedsat hos forsøgspersoner med en epiretinal membran (ERM) eller en VMA-diameter > 1500 mikrometer (se pkt.
English: Treatment with ocriplasmin did not demonstrate an effect on posterior vitreous detachment rate, vitreous liquefaction grade, immediate postoperative retinal reattachment rate, development of proliferative vitreoretinopathy, or stage of retinopathy of prematurity.
Danish: Behandlingen med ocriplasmin viste ingen virkning på forekomsten af posterior glaslegemeløsning, graden af likvefaktion af glaslegemet, forekomsten af omgående postoperativ nethindetilhæftning, udviklingen af proliferativ vitreoretinopati eller stadiet af præmatur retinopati.
English: Chromatopsia (including dyschromatopsia and colour vision test abnormal) Colour vision alterations (including yellowish vision and abnormal Roth 28-hue colour vision test) have been reported as a very common adverse reaction in patients injected with JETREA.
Danish: Kromatopsi (herunder dyskromatopsi og abnorm farvesynstest) Ændringer i farvesyn (herunder gulligt syn og abnorm Roth 28-farvers farvesynstest) blev rapporteret som en meget almindelig bivirkning hos patienter, som fik injiceret Jetrea.
English: The unopened vial in the original carton protected from light may be stored in a refrigerator (2 °C to 8 °C) for up to 1 week.
Danish: Det uåbnede hætteglas, i den oprindelige karton og beskyttet mod lys, kan opbevares i køleskab ved (2 °C til 8 °C) i op til en uge.
English: Very common Vitreous floaters, eye pain, conjunctival haemorrhage, chromatopsia*
Danish: Meget almindelige Mouches volantes, øjensmerter, konjunktival blødning, kromatopsi*
English: Figure 1: Proportion of patients with VMA resolution up to Day 180 (Month 6) (TG-MV-006, TG-MV-007 and integrated data)
Danish: Figur 1: Andel af patienter, der opnåede en nomalisering af VMA frem til dag 180 (måned 6) (TG-MV-006, TG-MV-007 og integrerede data)
English: Solution for injection (injection).
Danish: Injektionsvæske (opløsning).
English: Jetrea is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye).
Danish: Jetrea anvendes til at behandle voksne med en øjensygdom betegnet vitreomaculær traktion (VMT), herunder når det er forbundet med et lille hul i macula (”den gule plet”, som er den centrale del af det lysfølsomme cellelag bagest i øjet).
English: Pathological changes related to intraocular haemorrhage were observed in rabbits and monkeys.
Danish: Patologiske ændringer knyttet til intraokulær blødning blev observeret hos kaniner og aber.
English: See section 4.4 for instructions on post-injection monitoring.
Danish: 4.4 for instruktioner i monitorering efter injektionen.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om Jetrea findes på Det Europæiske Lægemiddelagenturs hjemmeside http://ema.europa.eu.
English: The incidence of retinal detachment that occurred pre-vitrectomy was 0.4% in the JETREA group and none in the placebo group, while the incidence of retinal tears (without detachment) that occurred pre-vitrectomy was 0.2% in the JETREA group and 0.5% in the placebo group.
Danish: Forekomsten af nethindeløsning før vitrektomi var henholdsvis 0,4 % i Jetrea-gruppen og ingen i placebogruppen, mens forekomsten af nethinderifter (uden nethindeløsning) før vitrektomi var 0,2 % i Jetrea-gruppen og 0,5 % i placebogruppen.
English: Subretinal fluid and signs and symptoms of impaired photoreceptor function including decreased visual acuity (in some cases severe) were reported in association with these events.
Danish: Der blev rapporteret subretinal væske samt tegn og symptomer på nedsat fotoreceptorfunktion, herunder nedsat visus (i nogle tilfælde i svær grad), i forbindelse med disse hændelser.
English: On the day of the injection, your doctor/ophthalmologist will use antimicrobial eye drops and clean your eye and eyelid carefully to prevent infection.
Danish: Inden din læge eller øjenlæge giver dig injektionen, vil de først dryppe øjet med antimikrobielle øjendråber og rense øjet og øjenlåget grundigt for at forhindre infektion.
English: The proportion of patients who underwent vitrectomy for an event of VMA/VMT was 8.3% in the JETREA group compared to 19.2% in the sham group.
Danish: Andelen af patienter, som fik foretaget vitrektomi for en hændelse med VMA/VMT, var 8,3 % i Jetrea-gruppen sammenlignet med 19,2 % i placebogruppen.
English: (17.1% and 6.4%) (p=0.003 and p=0.024, respectively).
Danish: (henholdsvis p = 0,003 og p=0,024).
English: In both pivotal studies, the proportion of patients who achieved VMA resolution at Day 28 (primary endpoint) was significantly (p≤0.003) higher in the JETREA group compared with the placebo group.
Danish: I begge pivotale studier var den andel af patienter, som opnåede en nomalisering af VMA på dag 28 (primære endpoint), signifikant (p ≤ 0,003) højere i Jetrea-gruppen sammenlignet med placebogruppen.
English: - Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or wobbling of the lens in the eye from its normal position.
Danish: - Symptomer såsom synsforstyrrelser, dobbeltsyn, hovedpine, glorier omkring lyskilder, kvalme og opkastning er rapporteret hos op til 1 ud af 100 patienter, og kan være tegn på, at linsen i øjet vipper eller er forskudt fra dens normale position.
English: Repeated administration in the same eye is not recommended (see section 4.4).
Danish: Gentagen administration i det samme øje anbefales ikke (se pkt.
English: Very common Retinogram abnormal*, colour vision test abnormal†
Danish: Abnormt retinogram*, abnorm farvesynstest†
English: Because of the small dose administered (0.125 mg), detectable levels of ocriplasmin in systemic circulation are not expected after intravitreal injection.
Danish: På grund af den lille mængde, der administreres (0,125 mg), forventes der ingen detekterbare koncentrationer af ocriplasmin i systemisk cirkulation efter intravitreal injektion.
English: JETREA should be used during breast-feeding only if the clinical benefit outweighs the potential risks.
Danish: Jetrea må kun anvendes under amning, hvis den kliniske fordel opvejer de potentielle risici.
English: JETREA is administered by intravitreal injection only.
Danish: Jetrea administreres kun ved intravitreal injektion.
English: Some tests and imaging of the back of the eye (retina) have been found to be abnormal after Jetrea administration.
Danish: Nogle tests og billedundersøgelser af det bageste i øjet (nethinden) har vist sig at være unormale efter indgift af Jetrea.
English: There are no data for the use of JETREA in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af Jetrea til gravide kvinder.
English: Early progression rates of full-thickness macular hole (until Day 7 post-injection) at RPE (retinal pigment epithelium) level were higher in the JETREA treated patients compared to sham or placebo.
Danish: Tidlige forekomster af maculahul med fuld tykkelse (indtil dag 7 efter injektionen) ved RPE (retinapigmentepitel) var højere hos patienter behandlet med Jetrea i forhold til placebo.
English: Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist.
Danish: Der kan administreres antibiotikadråber præoperativt efter den behandlende oftalmologs vurdering.
English: - The active substance is ocriplasmin.
Danish: - Aktivt stof: ocriplasmin (ocriplasminum).
English: Patients with no ERM at baseline were more likely to achieve VMA resolution at Day 28 compared with those who had ERM at baseline.
Danish: Patienter uden ERM ved baseline havde større sandsynlighed for at opnå en normalisering af VMA på dag 28 sammenlignet med patienter med ERM ved baseline.
English: Some effects (such as flashes, floaters) can also be perceived from the untreated eye in some cases.
Danish: I nogle tilfælde kan der også opleves bivirkninger såsom lysglimt og ”fluer” (pletter i synsfeltet) i det ubehandlede øje.
English: At Month 24, 51.4% of JETREA patients had a ≥ 5 points improvement in VFQ-25 composite score compared to 30.1% in the sham group.
Danish: Ved måned 24 havde 51,4 % af Jetrea-patienterne ≥ 5 point forbedring i den sammensatte score for VFQ25 sammenlignet med 30,1 % i placebogruppen.
English: Other medicines and Jetrea
Danish: Brug af anden medicin sammen med Jetrea
English: The proportion of patients with ≥3 lines improvement from baseline was only greater in the JETREA group (23.4% vs. 12.8%, respectively) in the subgroup who had no FTMH at baseline.
Danish: Andelen af patienter med en forøgelse på ≥ 3 linjer i forhold til baseline var kun større i Jetreagruppen (hhv. 23,4 % vs. 12,8 %) i den undergruppe, som ikke havde nogen FTMH ved baseline.
English: 0.3 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and a blue polypropylene flip-off cap.
Danish: 0,3 ml opløsning i et hætteglas (type I glas) lukket med en chlorobutyl gummiprop og en blå flip-offhætte af polypropylen.
English: The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical microbiocide should be administered prior to the injection according to standard medical practice.
Danish: Den periokulære hud, øjenlåget og den okulære overflade skal desinficeres, og tilstrækkelig anæstesi og et bredspektret topikalt antibiotikum skal administreres inden injektionen efter gældende medicinsk praksis.
English: Your doctor/ophthalmologist will monitor you in case you develop an infection or any complications after the injection.
Danish: Din læge/øjenlæge vil undersøge dig i tilfælde af, at du udvikler en betændelseslignende tilstand (infektion) eller eventuelle komplikationer efter injektionen.
English: 3) including cystoid macular oedema
Danish: 3) herunder cystoidt maculaødem
English: Your doctor/ophthalmologist will also give you a local anaesthetic to prevent any pain from the injection.
Danish: Din læge/øjenlæge vil muligvis også give dig lokalbedøvelse for at undgå eventuel smerte i forbindelse med injektionen.
English: The median time to resolution was 3 months.
Danish: Mediantiden til nomalisering var 3 måneder.
English: Jetrea must be given by a qualified ophthalmologist (eye specialist) who has experience in giving injections into the eye.
Danish: Jetrea skal gives af en specialuddannet oftalmolog (speciallæge i øjensygdomme), som har erfaring i at give injektioner i øjet.
English: In the integrated data, full-thickness macular hole (FTMH) was present at baseline in 106/464 (22.8%) patients and 47/188 (25%) patients in the JETREA and placebo groups, respectively.
Danish: I de integrerede data var fuld tykkelses macula-hul (FTMH) til stede hos henholdsvis 106/464 patienter (22,8 %) og 47/188 patienter (25 %) i Jetrea- og placebogrupperne ved baseline.
English: • How to prepare for Jetrea treatment
Danish: • Hvordan forberedes Jetrea-behandlingen
English: 0.2 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and an orange polypropylene flip-off cap.
Danish: 0,2 ml opløsning i et hætteglas (type I glas) lukket med en chlorobutyl gummiprop og en orange flipoff-hætte af polypropylen.
English: These include optical coherence tomography (OCT), ophthalmoscopy (foveal reflex), colour vision test (Roth 28-hue) and full-field ERG.
Danish: Disse kan være oftalmoskopi (foveal refleks), test af farvesyn (Roth 28 farver) og fuldfelts-ERG.
English: Contact your doctor/ophthalmologist immediately if you develop any of the following symptoms after injection of Jetrea.
Danish: Kontakt straks din læge/øjenlæge, hvis du udvikler et af følgende symptomer efter en injektion med Jetrea.
English: All adverse reactions were ocular.
Danish: Alle bivirkninger var okulære.
English: Study TG-MV-014
Danish: Studie TG-MV-014
English: Studies TG-MV-006 and TG MV-007
Danish: Studie TG-MV-006 og TG-MV-007
English: In study TG-MV-014, incomplete Inner Segment/Outer Segment (IS/OS) band, also referred to as Ellipsoid Zone, in the central area was very common at baseline (65.8% in the JETREA group and 62.2% in the sham group).
Danish: I studie TG-MV-014 var ukomplet indre/ydre segmentbånd (IS/OS) (også kaldet den ellipsoide zone) i det centrale område meget almindeligt ved baseline (65,8 % i Jetrea-gruppen og 62,2 % i placebogruppen).
English: Citric acid
Danish: Citronsyre (acidum citricum)
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, other than sterile, preservative-free, non-buffered diluent sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end steril natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, uden buffer eller konserveringsmiddel.
English: No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with renal impairment since the systemic exposure is expected to be very low after intravitreal administration.
Danish: Der er ikke udført nogen studier til undersøgelse af farmakokinetikken af ocriplasmin hos patienter med nedsat nyrefunktion, da den systemiske eksponering forventes at være meget lav efter intravitreal administration.
English: Store in a freezer (-20 °C ± 5 °C).
Danish: Opbevares i fryser (-20 °C ± 5 °C).
English: For storage conditions after thawing and opening/dilution of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold efter optøning og åbning/fortynding af lægemidlet, se pkt.
English: At Month 24, the proportion of patients with ≥ 2 lines improvement from baseline in BCVA was greater in the JETREA group than in the sham group (50.5% vs. 39.1%).
Danish: Ved måned 24 var andelen af patienter med ≥ 2 linjers forbedring i BCVA i forhold til baseline større i Jetrea-gruppen end i placebogruppen (50,5 % vs. 39,1 %).
English: The main reasons for vitrectomy were retinal detachment and retinopathy of prematurity.
Danish: Hovedårsagerne til vitrektomien var nethindeløsning og præmatur retinopati.
English: JETREA treated patients were less likely to have had a vitrectomy by the end of the study (Month 6) compared with placebo treated patients (integrated data: 17.7% vs. 26.6%, respectively; p=0.016).
Danish: Der var mindre sandsynlighed for, at patienter behandlet med Jetrea havde gennemgået vitrektomi ved studiets afslutning (6. måned) sammenlignet med patienter behandlet med placebo (integrerede data: 17,7 % vs. 26,6 %; p = 0,016).
English: There is no experience of using Jetrea in pregnant women or during breast-feeding.
Danish: Der er ingen erfaring med brug af Jetrea til gravide eller ammende kvinder.
English: No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with hepatic impairment since the systemic exposure is expected to be very low after intravitreal administration.
Danish: Der er ikke udført nogen studier til undersøgelse af farmakokinetikken af ocriplasmin hos patienter med nedsat leverfunktion, da den systemiske eksponering forventes at være meget lav efter intravitreal administration.
English: However, after treatment, a higher proportion of patients in the JETREA group had a change from an intact IS/OS band at baseline to an incomplete IS/OS band in the central area at a later time point compared with the sham group (7.7% and 2.8%, respectively at Day 28).
Danish: Efter behandling havde en større andel af patienterne i Jetrea-gruppen imidlertid en ændring fra et intakt IS/OS-bånd ved baseline til et ukomplet IS/OS-bånd i det centrale område på et senere tidspunkt sammenlignet med placebogruppen (henholdsvis 7,7 % og 2,8 % ved dag 28).
English: No dose adjustment or special considerations are anticipated for patients with renal impairment (see section 5.2).
Danish: Der forventes ingen dosisjustering eller særlige hensyn for patienter med nedsat leverfunktion (se pkt.
English: JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted' formulation, no further dilution is required.
Danish: Jetrea 0,375 mg/0,3 ml injektionsvæske er en “færdigfortyndet” formel, der ikke kræver yderligere fortynding.
English: ≥ 3 lines in BCVA without vitrectomy favoured JETREA at Month 6 (23.7% vs. 11.2%, p<0.001 for a gain ≥ 2 lines and 9.7% vs. 3.7%, p=0.008 for a gain ≥ 3 lines).
Danish: ≥ 3 linjer i BCVA uden vitrektomi en fordel ved Jetrea i 6. måned (23,7 % vs. 11,2 %, p<0,001 for en forøgelse på ≥ 2 linjer og 9,7 % vs. 3,7 %, p=0,008 for en forøgelse på ≥ 3 linjer).
English: JETREA has not been studied in patients with large diameter macular holes (> 400 microns), high myopia (> 8 dioptre spherical correction or axial length > 28 mm), aphakia, history of rhegmatogenous retinal detachment, lens zonule instability, recent ocular surgery or intraocular injection (including laser therapy), proliferative diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions, exudative age-related macular degeneration (AMD) and vitreous haemorrhage.
Danish: Jetrea er endnu ikke undersøgt hos patienter med maculahuller med stor diameter (> 400 mikrometer), høj myopi (> 8 dioptri sfærisk korrektion eller aksial længde > 28 mm), afaki, fortilfælde af rhegmatogen nethindeløsning, manglende zonulær linsestabilitet, nylig okulær kirurgi eller intraokulær injektion (herunder laserbehandling), proliferativ diabetisk retinopati, iskæmisk retinopati, retinal veneokklusion, exudativ aldersrelateret maculadegeneration (AMD) og glaslegemeblødning.
English: Out of the 4 JETREA patients with acute visual acuity decrease, 3 recovered following vitrectomy.
Danish: Af de 4 Jetrea-patienter med akut nedsat visus normaliseredes tilstanden for de 3 efter vitrektomi.
English: The most clinically relevant adverse reactions included blindness transient, retinal tear, retinal detachment, lens subluxation and macular hole progression.
Danish: De klinisk mest relevante bivirkninger var forbigående blindhed, nethinderift, nethindeløsning, linsesubluksation og progression af maculahul.
English: The proportion of patients who gained ≥ 2 or ≥ 3 lines in BCVA at Month 6, irrespective of vitrectomy, was slightly higher in the JETREA group (36.2%, 18.6%) than in the sham group (28.6%, 13.1%).
Danish: Andelen af patienter, som oplevede en forøgelse på ≥ 2 eller ≥ 3 linjer i BCVA ved måned 6, uanset om der var foretaget vitrektomi eller ej, var lidt højere i Jetrea-gruppen (36,2 %, 18,6 %) end i placebogruppen (28,6 %, 13,1 %).
English: In study TG-MV-014, 2.8% of JETREA patients and 1.4% of sham patients had acute ≥ 2-line loss in BCVA during the first week after injection.
Danish: I studiet TG-MV-014 oplevede 2,8 % af Jetrea-patienterne og 1,4 % af placebopatienterne akut tab ≥ 2 linjer i BCVA i løbet af den første uge efter injektionen.