FrancophonIA/ELRC3.0 huggingface dataset:
English: One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.
Danish: Et hætteglas (type I-glas) med en prop (chlorbutylgummi) med 0,23 ml steril opløsning.
English: Lucentis and verteporfin photodynamic therapy in CNV secondary to PM There is no experience of concomitant administration of Lucentis and verteporfin.
Danish: Behandling med Lucentis og fotodynamisk behandling med verteporfin ved CNV som følge af PM Der er ingen erfaringer med samtidig administration af Lucentis og verteporfin.
English: Rubber stopper
Danish: Gummistopper
English: 1x 0.23 ml vial, 1 filter needle.
Danish: 1 x 0,23 ml hætteglas, 1 filterkanyle.
English: In the ranibizumab-treated group, ≥2-step improvement in DRSS from baseline was observed in 58.5% (n=24) of eyes with baseline DME and 37.8% (n=56) of eyes without DME.
Danish: I den ranibizumab-behandlede gruppe blev der set ≥2-trins forbedring i DRSS i forhold til baseline i 58,5 % (n=24) af øjnene med DME ved baseline og i 37,8 % (n=56) af øjnene uden DME ved baseline.
English: The pre-filled syringe contains 0.165 ml of a sterile, clear, colourless to pale yellow aqueous solution.
Danish: Den fyldte injektionssprøjte indeholder 0,165 ml steril, klar, farveløs til svagt gul, vandig væske.
English: Lucentis can be administered in patients who have received previous laser photocoagulation.
Danish: Lucentis kan administreres til patienter, der tidligere er behandlet med laser.
English: Your baby must not receive Lucentis - If your baby is allergic to ranibizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Dit barn må ikke få Lucentis - Hvis dit barn er allergisk over for ranibizumab eller et af de øvrige indholdsstoffer i Lucentis
English: After injection any unused product must be discarded.
Danish: Efter injektionen skal alt overskydende lægemiddel kasseres.
English: Upon monthly intravitreal administration of Lucentis 0.5 mg/eye, serum ranibizumab Cmax, attained approximately 1 day after dosing, is predicted to generally range between 0.79 and 2.90 ng/ml, and Cmin is predicted to generally range between 0.07 and 0.49 ng/ml.
Danish: Ved månedlig intravitreal indgivelse af Lucentis 0,5 mg/øje forventes Cmax for serumranibizumab opnået ca. 1 dag efter dosering generelt at ligge mellem 0,79 og 2,90 ng/ml.
English: At year 1, 41.8% of eyes experienced a ≥2-step improvement in the DRSS when treated with ranibizumab (n=189) compared to 14.6% of eyes treated with PRP (n=199).
Danish: Ved år 1 opnåede 41,8 % af øjnene ≥2-trins forbedring i DRSS ved behandling med ranibizumab (n=189) sammenlignet med 14,6 % af øjnene behandlet med PRP (n=199).
English: Patients should be informed of the symptoms of these potential adverse reactions and instructed to inform their physician if they develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in their vision, or increased sensitivity to light (see section 4.8).
Danish: Patienter bør informeres om symptomerne på disse potentielle bivirkninger, og instrueres i at informere deres læge, hvis de udvikler symptomer såsom øjensmerter eller øget utilpashed, forværring af røde øjne, sløret eller nedsat syn, et øget antal små partikler i deres synsfelt eller øget lysfølsomhed (se pkt.
English: The symptoms you might experience are pain or increased discomfort in your eye, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light.
Danish: De symptomer du kan opleve, er øjensmerter eller øget ubehag i dit øje, forværring af rødme i øjet, sløret eller nedsat syn, et øget antal små partikler i synsfeltet, eller øget følsomhed for lys.
English: Prior laser n=74
Danish: Tidligere laser n=74*
English: Lucentis is a solution which is injected into the eye. Lucentis belongs to a group of medicines called antineovascularisation agents.
Danish: Lucentis tilhører en gruppe af lægemidler, som kaldes anti-neovaskulære midler.
English: This will expel the air and the excess solution and set the dose to 0.05 ml.
Danish: Dette vil presse luft og overskydende injektionsvæske ud og indstille dosis på 0,05 ml.
English: Less frequently reported, but more serious, adverse reactions include endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.4).
Danish: Mindre hyppigt rapporterede, men mere alvorlige, bivirkninger omfatter endoftalmit, blindhed, nethindeløsning, nethinderift og iatrogen traumatisk katarakt (se pkt.
English: Please tell the doctor immediately if your baby develops signs such as eye pain or worsening eye redness.
Danish: Kontakt straks lægen, hvis dit barn udvikler symptomer såsom øjensmerter eller forværring af rødme i øjet.
English: Mean average BCVA change from Month 1 to Month 3 compared to baseline a
Danish: Gennemsnitlig ændring i BCVA fra måned 1 til måned 3 i forhold til baseline a
English: Gain of ≥15 letters or BCVA ≥84 letters at Month 36 (%) Mean number of injections (Months 12-35)* p<0.0001 for comparisons of ranibizumab arms vs. laser arm. n in D2301-E1 (RESTORE Extension) is the number of patients with a value at both D2301 (RESTORE) baseline (Month 0) and at the Month 36 visit.
Danish: Gennemsnitlig ændring i BCVA ved måned 24 (SD) Gennemsnitlig ændring i BCVA ved måned 36 (SD) Bedring på ≥15 bogstaver eller BCVA ≥84 bogstaver ved måned 36 (%) Gennemsnitligt antal injektioner (måned 12-35)* p<0,0001 for sammenligninger af ranibizumab-arme vs. laser-arm. n i D2301-E1 (RESTORE Extension) er antal patienter med en værdi både ved baseline i D2301 (RESTORE) (måned 0) og ved besøget ved måned 36.
English: Other medicines and Lucentis Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Lucentis Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: 95% CI
Danish: 95% CI p-værdi b
English: Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper.
Danish: Pakning, der indeholder 1 hætteglas med ranibizumab med chlorbutylgummiprop.
English: 0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip cap including a Luer lock adapter.
Danish: 0,165 ml steril injektionsvæske i en fyldt injektionssprøjte (type I glas) med en stempelstopper af brombutyl-gummi og en sprøjte-hætte bestående af en hvid, manipuleringssikker, hård forsegling med en grå hættetop af brombutyl-gummi samt en Luer-lock-adapter.
English: Treatment of visual impairment due to macular oedema secondary to RVO The clinical safety and efficacy of Lucentis in patients with visual impairment due to macular oedema secondary to RVO have been assessed in the randomised, double-masked, controlled studies BRAVO and CRUISE that recruited subjects with BRVO (n=397) and CRVO (n=392), respectively.
Danish: Behandling af synsnedsættelse grundet maculaødem som følge af RVO Den kliniske sikkerhed og effekt af Lucentis er blevet undersøgt hos patienter med synsnedsættelse grundet maculaødem som følge af RVO i de to randomiserede, dobbeltblinde, kontrollerede studier, BRAVO og CRUISE, til hvilke der blev rekrutteret patienter med henholdsvis BRVO (n=397) og CRVO (n=392).
English: In study FVF3192g (PIER), 184 patients with all forms of neovascular AMD were randomised in a 1:1:1 ratio to receive Lucentis 0.3 mg, Lucentis 0.5 mg or sham injections once a month for 3 consecutive doses, followed by a dose administered once every 3 months.
Danish: I studie FVF3192g (PIER) blev 184 patienter med alle former for neovaskulær AMD randomiseret i forholdet 1:1:1 til at få Lucentis 0,3 mg, Lucentis 0,5 mg eller sham injektioner en gang om måneden i 3 på hinanden følgende måneder efterfulgt af en dosis indgivet en gang hver 3. måned.
English: How to prepare and administer Lucentis to adults
Danish: Tilberedning og administration af Lucentis til voksne
English: If you observe any side effects in your baby, talk to your baby`s doctor.
Danish: Hvis du oplever bivirkninger hos dit barn, bør du tale med dit barns læge.
English: Non-visual side effects include: Headache and joint pain.
Danish: Bivirkninger uden for øjet omfatter: Hovedpine og smerte i leddene.
English: In preterm infants, the injection needle should be inserted into the eye 1.0 to 2.0 mm posterior to the limbus, with the needle pointing towards the optic nerve.
Danish: Hos præmature spædbørn skal injektionsnålen føres ind i øjet 1,0 til 2,0 mm posteriort for limbus, idet nålen rettes mod synsnerven.
English: A different scleral site should be used for subsequent injections.
Danish: Stedet på sklera skal roteres ved efterfølgende injektioner.
English: It contains the active substance called ranibizumab.
Danish: Det indeholder det aktive indholdsstof ranibizumab.
English: • a sterile pre-filled syringe in a sealed tray.
Danish: • En steril, fyldt injektionssprøjte i en forseglet bakke.
English: Outcome measures at Month 12 compared to baseline in study D2301 (RESTORE)
Danish: Resultater ved måned 12 sammenlignet med baseline i studie D2301 (RESTORE)
English: Set dose to 0.05 ml dose mark.
Danish: Indstil dosis til 0,05 ml-doseringsmærket.
English: There are limited data on safety in the treatment of DME, macular oedema due to RVO and CNV secondary to PM patients with prior history of stroke or transient ischaemic attacks.
Danish: Der er begrænsede sikkerhedsdata vedrørende behandling af patienter med henholdsvis DME, maculaødem som følge af RVO og CNV som følge af PM, der tidligere har haft apopleksi eller transitorisk cerebral iskæmi (TCI).
English: The side effects associated with the administration of Lucentis are due either to the medicine itself or to the injection procedure and mostly affect the eye.
Danish: Bivirkningerne, der er forbundet med indgivelsen af Lucentis, stammer enten fra medicinen eller fra injektionsproceduren og ses som regel i øjet.
English: Hepatic impairment: No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with hepatic impairment.
Danish: Leverinsufficiens: Der er ikke udført formelle studier til undersøgelse af farmakokinetikken af Lucentis hos patienter med leverinsufficiens.
English: Statistically significant patient-reported benefits for most vision-related functions were observed with ranibizumab (with or without laser) treatment over the control group as measured by the NEI VFQ-25.
Danish: Der blev observeret statistisk signifikante patientrapporterede fordele for de fleste synsrelaterede funktioner ved behandling med ranibizumab (med eller uden laser) i forhold til kontrolgruppen, bedømt ved NEI VFQ-25.
English: Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Danish: Lucentis skal indgives af en øjenlæge med erfaring i intravitreale injektioner.
English: Please tell your doctor immediately if you develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light.
Danish: Du bedes straks oplyse din læge det, hvis du udvikler symptomer såsom øjensmerter eller øget ubehag, forværring af rødme i øjet, sløret eller nedsat syn, et øget antal små partikler i synsfeltet eller øget følsomhed for lys.
English: - Macular oedema (swelling of the centre of the retina).
Danish: - Maculaødem (opsvulmen af den midterste del af nethinden).
English: In study FVF2587g (ANCHOR), 423 patients with predominantly classic CNV lesions were randomised in a 1:1:1 ratio to receive Lucentis 0.3 mg monthly, Lucentis 0.5 mg monthly or verteporfin PDT (at baseline and every 3 months thereafter if fluorescein angiography showed persistence or recurrence of vascular leakage).
Danish: I studie FVF2587g (ANCHOR) blev 423 patienter med overvejende klassiske CNV-læsioner randomiseret i forholdet 1:1:1 til at få Lucentis 0,3 mg månedligt, Lucentis 0,5 mg månedligt eller verteporfin-PDT (ved baseline og hver 3. måned derefter, hvis fluorescensangiografi viste persistens eller recidiv af vaskulær lækage).
English: (branch RVO or central RVO)
Danish: (grenveneokklusion eller centralveneokklusion)
English: The safety and efficacy of ranibizumab have not yet been established in paediatric patients.
Danish: Ranibizumabs sikkerhed og virkning hos børn er endnu ikke klarlagt.
English: Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe.
Danish: Fjern forsigtigt hætten fra den sterile kanyle uden at fjerne kanylen fra sprøjten.
English: The pre-filled syringe is sterile.
Danish: Den fyldte injektionssprøjte er steril.
English: Lucentis will be administered by an eye doctor as a single injection into your baby's eyes, usually under local anaesthetic.
Danish: Lucentis gives som en enkelt injektion i dit barns øjne af en øjenlæge, som regel under lokalbedøvelse.
English: Package leaflet: Information for the adult patient
Danish: Indlægsseddel: Information til den voskne patient
English: The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
Danish: Injektionskanylen skal føres ind 3,5-4,0 mm posteriort for limbus i corpus vitreum-hulen, idet den horisontale meridian undgås, og der sigtes mod øjeæblets centrum.
English: In adults the injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
Danish: Hos voksne skal injektionskanylen føres ind 3,5-4,0 mm posteriort for limbus i corpus vitreum-hulen, idet den horisontale meridian undgås, og der sigtes mod øjeæblets centrum.
English: This corresponds to an injection volume of 0.05 ml.
Danish: Dette svarer til et injektionsvolumen på 0,05 ml.
English: Adverse reactions associated with these reported cases were intraocular pressure increased, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain.
Danish: De hændelser, som var mest forbundet med disse tilfælde var stigning i det intraokulære tryk, forbigående synstab, nedsat synsskarphed, cornea ødem, smerte i cornea og øjensmerter.
English: Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial.
Danish: Pres filterkanylen ned i midten af hætteglassets gummiprop indtil nålen når hætteglassets bund.
English: In the phase III study D2301 (RESTORE), 345 patients were randomised in a 1:1:1 ratio to receive ranibizumab 0.5 mg monotherapy and sham laser photocoagulation, combined ranibizumab 0.5 mg and laser photocoagulation or sham injection and laser photocoagulation.
Danish: I fase III-studiet D2301 (RESTORE) blev 345 patienter randomiseret i forholdet 1:1:1 til at få ranibizumab 0,5 mg monoterapi og sham-laserbehandling, kombineret ranibizumab 0,5 mg og laserbehandling eller sham-injektion og laserbehandling.
English: Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, all of which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, pathologic myopia and CNV or to visual impairment caused by either diabetic macular oedema or macular oedema secondary to RVO in adults and retinopathy of prematurity in preterm infants.
Danish: Binding af VEGF-A til dets receptorer medfører endotelial celleproliferation og neovaskularisation samt vaskulær lækage, som alt sammen menes at bidrage til progressionen af den neovaskulære form af aldersrelateret maculadegeneration, patologisk myopi og CNV eller til synsnedsættelse forårsaget af enten diabetisk maculaødem eller maculaødem som følge af RVO hos voksne og præmatur retinopati hos præmature spædbørn.
English: Intravitreous injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.8).
Danish: Intravitreale injektioner, herunder injektioner med Lucentis, er blevet sat i forbindelse med endoftalmit, intraokulær inflammation, rhegmatogen nethindeløsning, nethinderift og iatrogen traumatisk katarakt (se pkt.
English: Visual side effects include: Bleeding in the back of the eye (retinal bleeding), bleeding in the eye or at the site of injection, and bloodshot eye (conjunctival bleeding).
Danish: Bivirkninger, der påvirker synet omfatter: Blødning i den bagerste del af øjet (nethindeblødning), blødning i øjet eller ved injektionsstedet og blodskudte øjne (konjunktival blødning).
English: For ranibizumab no clinical data on exposed pregnancies are available.
Danish: Der er ingen data fra anvendelse af ranibizumab til gravide kvinder.
English: Alcon-Couvreur NV Rijksweg 14
Danish: Alcon-Couvreur N.V.
English: If you are considering stopping Lucentis treatment for your baby, please go to your next appointment and discuss this with your baby's doctor.
Danish: Hvis barnet holder op med at få behandling med Lucentis Hvis du overvejer at holde op med Lucentis-behandlingen til dit barn, bedes du komme til din næste aftale og drøfte det med dit barns læge.
English: Lucentis is administered as a single injection into your eye by your eye doctor under a local anaesthetic.
Danish: Lucentis administreres som en enkel injektion i dit øje af din øjelæge, under lokalbedøvelse.
English: Treatment of visual impairment due to CNV (other than secondary to PM and wet AMD) The clinical safety and efficacy of Lucentis in patients with visual impairment due to CNV have been assessed based on the 12-month data of the double-masked, sham-controlled pivotal study G2301 (MINERVA).
Danish: Behandling af synsnedsættelse grundet CNV (undtagen sekundært til PM og våd AMD) Lucentis' kliniske sikkerhed og virkning hos patienter med synsnedsættelse grundet CNV er blevet vurderet på baggrund af det dobbeltblinde, sham-kontrollerede pivotale studie G2301 af 12 måneders varighed (MINERVA).
English: An improvement of vision was observed and was accompanied by a reduction in central subfield thickness over the 12-month period.
Danish: Der blev observeret en forbedring af synet, ledsaget af en reduktion i central retinal tykkelse over 12-måneders perioden.
English: The most serious side effects in adults are described below:
Danish: De mest alvorlige bivirkninger hos voksne er beskrevet nedenfor:
English: This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab to adult patients and a single dose of 0.02 ml containing 0.2 mg ranibizumab to preterm infants.
Danish: Dette giver en brugbar mængde til at levere en enkelt dosis på 0,05 ml indeholdende 0,5 mg ranibizumab til voksne, og en enkelt dosis på 0,02 ml indeholdende 0,2 mg ranibizumab til præmature spædbørn.
English: The improvement of vision was accompanied by a reduction in central retinal thickness.
Danish: Synsforbedringen var ledsaget af en reduktion i central retinal tykkelse.
English: Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, all of which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, pathologic myopia and CNV or to visual impairment caused by either diabetic macular oedema or macular oedema secondary to RVO.
Danish: Binding af VEGF-A til dets receptorer medfører endotelial celleproliferation og neovaskularisation samt vaskulær lækage, som alt sammen menes at bidrage til progressionen af den neovaskulære form af aldersrelateret maculadegeneration, patologisk myopi og CNV eller til synsnedsættelse forårsaget af enten diabetisk maculaødem eller maculaødem som følge af RVO.
English: Lucentis has not been studied in patients with hepatic impairment.
Danish: Lucentis er ikke undersøgt hos patienter med leverinsufficiens.
English: How to prepare and administer Lucentis to preterm infants
Danish: Tilberedning og administration af Lucentis til for tidligt fødte spædbørn
English: TE ranibizumab 0.5 mg alone n=125
Danish: TE-ranibizumab 0,5 mg alene n=125
English: Solution for injection Novartis Pharma GmbH Roonstrasse 25
Danish: Injektionsvæske, opløsning Novartis Pharma GmbH Roonstrasse 25
English: Each pre-filled syringe of 0.165 ml solution contains 1.65 mg of ranibizumab (10 mg/ml).
Danish: Hver fyldt injektionssprøjte med 0,165 ml injektionsvæske indeholder 1,65 mg ranibizumab (10 mg/ml).
English: Each vial contains 2.3 mg ranibizumab in 0.23 ml solution.
Danish: Hvert hætteglas indeholder 2,3 mg ranibizumab i 0,23 ml opløsning.
English: Other side effects in adults are described below:
Danish: Andre bivirkninger, som forekommer hos voksne, er beskrevet nedenfor:
English: One pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg ranibizumab.
Danish: En fyldt sprøjte indeholder 0,165 ml, svarende til 1,65 mg ranibizumab.
English: Blindness, endophthalmitis, hypopyon, hyphaema, keratopathy, iris adhesion, corneal deposits, corneal oedema, corneal striae, injection site pain, injection site irritation, abnormal sensation in eye, eyelid irritation.
Danish: Blindhed, endophthalmitis, hypopyon, hyphaema, keratopati, iris adhæsion, hornhindeaflejring, cornea ødem, striae corneae, smerter ved injektionsstedet, irritation ved injektionsstedet, abnorm følelse i øjet, øjenlågsirritation.
English: To prepare Lucentis for intravitreal administration to preterm infants please adhere to the instructions for use in the VISISURE kit.
Danish: For at forberede Lucentis til intravitreal injektion til præmature spædbørn, skal brugsanvisningen i VISISURE-sættet følges.
English: Visual side effects include: Inflammation and bleeding in the front part of the eye, sac of pus on the eye, changes of the central part of the eye surface, pain or irritation at the site of injection, abnormal sensation in the eye, irritation of the eyelid.
Danish: Bivirkninger i øjet omfatter: Inflammation og blødning i den forreste del af øjet, pusansamling i øjet, forandringer i den midterste del af øjets overflade, smerter eller irritation ved injektionsstedet, unormal følelse i øjet, øjenlågsirritation.
English: Outcome measure at Month 36 compared to D2301 (RESTORE) baseline in study D2301-E1 (RESTORE Extension)
Danish: Resultat ved måned 36 sammenlignet med baseline fra D2301 (RESTORE) i studie D2301-E1 (RESTORE Extension)
English: Treatment is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity i.e. no change in visual acuity and in other signs and symptoms of the disease under continued treatment.
Danish: Behandlingen initieres med én injektion pr. måned, indtil maksimal synsskarphed er opnået og/eller der ikke er tegn på sygdomsaktivitet, dvs. ingen ændring i synsskarphed og i andre tegn og symptomer på sygdommen under fortsat behandling.
English: Product-class-related adverse reactions
Danish: Klasse-relaterede bivirkninger
English: In a meta-analysis of these studies, 48.4% of the 315 patients with gradable DRSS scores in the subgroup of patients with moderately severe non-proliferative DR (NPDR) or worse at baseline experienced a ≥2-step improvement in the DRSS at Month 12 when treated with ranibizumab (n=192) vs 14.6% of patients treated with laser (n=123).
Danish: I en metaanalyse af disse studier oplevede 48,4 % ud af de 315 patienter med graduerede DRSS-scorer hos undergruppen af patienter med moderat svær non-proliferativ DR (NPDR) eller værre ved baseline en ≥2-trins forbedring i DRSS ved måned 12 ved behandling med ranibizumab (n=192) mod 14,6 % af patienter behandlet med laser (n=123).
English: Clear, colourless to pale yellow aqueous solution.
Danish: Klar, farveløs til svagt gul vandig opløsning.