natgillin/translations-raw huggingface dataset:
De hyppigste bivirkninger (som ses hos mere end 1 ud af 10 patienter) er forhøjet intraokulært tryk (trykket inde i øjet), hovedpine, vitritis (betændelse i øjet), glaslegemeløsning (forskydning af væskedelen i den bageste del af øjet), nethindeblødning (blødning bagest i øjet), synsforstyrrelser, øjensmerter, pletter i synsfeltet (” flyvende fluer ”), konjunktival blødning (blødning forrest i øjet), øjenirritation, fornemmelsen af at have noget i øjet, øget tåreproduktion, blefaritis (øjenlågsbetændel - se), tørre øjne, okulær hyperæmi (røde øjne), kløe i øjnene, artralgi (ledsmerter) og rhinofaryngitis (betændelse i næse og svælg).
The most common side effects with Lucentis (seen in more than 1 in 10 patients) are increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the fluid in the eye from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, eye pain, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (tear production), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (red eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat).
Den fuldstændige liste over de indberettede bivirkninger ved Lucentis fremgår af indlægssedlen.
For the full list of all side effects reported with Lucentis, see the Package Leaflet.
I sjældne tilfælde kan der efter behandling med Lucentis opstå endoftalmitis (betændelse i øjets indre strukturer), kraftig øjenirritation, beskadigelse af nethinden og grå stær.
Rarely, endophthalmitis (an infection inside the eye), serious eye inflammation, damage to the retina and cataract (clouding of the lens) can occur after Lucentis treatment.
Det er vigtigt, at sådanne problemer bliver behandlet snarest muligt.
It is important to treat these problems as soon as possible.
Indlægssedlen indeholder en beskrivelse af de symptomer, de giver anledning til, og hvad der skal gøres, hvis de optræder hos patienten.
Their symptoms and instructions about what to do if a patient has them are explained in the Package Leaflet.
Da indsprøjtninger i øjet kan medføre en midlertidig trykstigning i øjet, vil øjenlægen efter indsprøjtningen kontrollere trykket og om nødvendigt korrigere det.
As injections into the eye can cause a temporary increase in the pressure within the eye, the ophthalmologist will check for this after the injection and take corrective measures if needed.
Lucentis bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for ranibizumab eller andre af indholdsstofferne.
Lucentis should not be used in patients who may be hypersensitive (allergic) to ranibizumab or any of the other ingredients.
Det må desuden ikke bruges hos patienter med infektion i øjet eller i øjenomgivelserne eller til patienter med en alvorlig betændelsestilstand inde i øjet.
It must not be used in patients who may have an infection of the eye or the area around the eye, or who have severe inflammation within the eye.
Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at der er bivirkninger forbundet med Lucentis, men at de opvejes af de fordele, der er påvist på overbevisende måde og som vedvarer i op til to år.
The Committee for Medicinal Products for Human Use (CHMP) noted that Lucentis is associated with side effects, but that this is balanced by benefits that have been shown convincingly and maintained for up to two years.
Udvalget fandt, at fordelene ved Lucentis er større end risiciene ved behandling af neovaskulær (våd) AMD.
The Committee decided that Lucentis’ s benefits are greater than its risks for the treatment of neovascular (wet) AMD.
Da virkningen af Lucentis var lidt bedre hos patienter, der fik 0, 5 mg, og da de hyppigst forekommende bivirkninger ikke var alvorlige, anbefalede udvalget udstedelse af markedsføringstilladelse for denne dosis.
Since the effectiveness of Lucentis was slightly greater in the patients receiving the 0.5 mg dose and the most common side effects were not serious, the Committee recommended that this dose of Lucentis should be given a marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Lucentis?
Which measures are being taken to ensure the safe use of Lucentis?
Det firma, der fremstiller Lucentis, vil udarbejde en informationspakke til læger med oplysninger om, hvilke forholdsregler der skal træffes for at mindske infektionsrisikoen ved indsprøjtninger i øjet.
The company that makes Lucentis will provide information packs for doctors (including information on the measures needed to minimise the risk of infection associated with injections into the eye) and for patients (to help them prepare for Lucentis treatment, recognise serious side effects and know
2/ 3 Desuden vil firmaet udarbejde en informationspakke til patienter med henblik på, at de kan forberede sig på behandlingen med Lucentis, er opmærksomme på alvorlige bivirkninger og ved, hvornår de skal søge akut lægehjælp.
2/ 3 when to seek urgent attention from their doctor).
Firmaet vil desuden nøje overvåge lægemidlets bivirkninger og sikkerhed.
The company will also closely monitor the side effects and safety of the medicine.
Andre oplysninger om Lucentis:
Other information about Lucentis:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lucentis til Novartis Europharm Limited den 22. januar 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Lucentis to Novartis Europharm Limited on 22 January 2007.
Den fuldstændige (EPAR) for Lucentis findes her.
The full EPAR for Lucentis can be found here.
Emballage
Package size
Intavitreal anvendelse
Intravitreal use Vial (glass)
Lucentis 10 mg/ ml injektionsvæske, opløsning
Lucentis 10 mg/ ml solution for injection
1 ml indeholder 10 mg ranibizumab.
One ml contains 10 mg ranibizumab.
Hvert hætteglas indeholder 2, 3 mg ranibizumab i 0, 23 ml opløsning.
Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution.
Ranibizumab er et humaniseret monoklonalt antistoffragment fremstillet i Escherichia coli- celler vha. rekombinant dna- teknologi.
Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Steril, klar, farveløs til svagt gul vandig opløsning.
Sterile, clear, colourless to pale yellow aqueous solution.
5. 1).
Lucentis is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1).
Lucentis skal indgives af en uddannet øjenlæge med erfaring i intravitreale injektioner.
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Den anbefalede dosis af Lucentis er 0, 5 mg (0, 05 ml).
The recommended dose for Lucentis is 0.5 mg (0.05 ml).
Lucentisbehandling indledes med en opfyldningsfase (loading- fase) bestående af 1 injektion pr. måned i 3 på hinanden følgende måneder efterfulgt af en vedligeholdelsesfase, hvor patienterne skal monitoreres mht. synsstyrke en gang om måneden.
Lucentis treatment is initiated with a loading phase of one injection per month for three consecutive months, followed by a maintenance phase in which patients should be monitored for visual acuity on a monthly basis.
Hvis patienten får et tab på mere end 5 bogstaver i synsstyrke (ETDRS- synstavle eller svarende til 1 Snellen- linje), bør der gives Lucentis.
If the patient experiences a loss of greater than 5 letters in visual acuity (ETDRS or one Snellen line equivalent), Lucentis should be administered.
Intervallet mellem 2 doser må ikke være mindre end 1 måned.
The interval between two doses should not be shorter than 1 month.
Som alle lægemidler til parenteral anvendelse skal Lucentis inspiceres visuelt for partikelmateriale og misfarvning før indgivelse.
As with all medicinal products for parenteral use, Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
Forud for behandling bør patienten instrueres i at anvende antimikrobielle øjendråber (4 gange daglig i 3 dage før og efter hver injektion).
Before treatment, the patient should be instructed to self-administer antimicrobial drops (four times daily for 3 days before and following each injection).
4. 4).
The patient ’ s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
Perioculær hud, øjenlåg og okulær overflade bør desinficeres og hensigtsmæssig anæstesi og et bredspektret topisk mikrobicid skal administreres før injektionen.
The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
6. 6.
For information on preparation of Lucentis, see section 6.6.
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.
2 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.
Stedet på sklera skal roteres ved efterfølgende injektioner.
The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.
Leverinsufficiens Lucentis er ikke undersøgt hos patienter med leverinsufficiens.
Hepatic impairment Lucentis has not been studied in patients with hepatic impairment.
5. 2).
Renal impairment Dose adjustment is not needed in patients with renal impairment (see section 5.2).
Børn og unge På grund af manglende dokumentation for sikkerhed og virkning hos børn og unge bør Lucentis ikke anvendes hos disse delpopulationer.
Children and adolescents Lucentis is not recommended for use in children and adolescents due to a lack of data on safety and efficacy in these sub-populations.
Ældre Dosisjustering er ikke påkrævet hos ældre.
Elderly No dose adjustment is required in the elderly.
Etnisk Erfaring med behandling er begrænset hos andre grupper end den kaukasiske.
Ethnicity Experience with treatment is limited in groups other than Caucasians.
Behandling med Lucentis er kun til intravitreal injektion.
Treatment with Lucentis is for intravitreal injection only.
4. 8).
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).
Der er set stigning i det intraokulære tryk inden for 60 minutter fra injektion af Lucentis (se pkt.
Increases in intraocular pressure have been seen within 60 minutes of injection of Lucentis (see section 4.8).
Både intraokulært tryk og perfusionen af synsnervepapillen skal derfor monitoreres og behandles på behørig vis.
Both intraocular pressure and the perfusion of the optic nerve head must therefore be monitored and managed appropriately.
Sikkerhed og effekt af behandling med Lucentis, når det indgives i begge øjne samtidigt er ikke blevet undersøgt.
The safety and efficacy of Lucentis therapy administered to both eyes concurrently have not been studied.
Hvis der på samme tid udføres bilateral behandling kan det give anledning til en øget systemisk effekt, som kunne øge risikoen af bivirkninger.
If bilateral treatment is performed at the same time this could lead to an increased systemic exposure, which could increase the risk of systemic adverse events.
Som ved alle terapeutiske proteiner er der risiko for immunogenicitet ved brug af Lucentis.
As with all therapeutic proteins, there is a potential for immunogenicity with Lucentis.
Dette kan være et klinisk tegn på intraoculær antistofdannelse.
Patients should be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation.
Lucentis er ikke blevet undersøgt hos patienter, som kort tid inden behandling har modtaget
Lucentis has not been studied in patients who have previously received intravitreal injections.
3 intravitreale injektioner.
3 Lucentis should not be administered concurrently with other anti-VEGF agents (systemic or ocular).
Dosis bør tilbageholdes, og behandlingen bør ikke genoptages tidligere end den næste fastsatte behandling i følgende tilfælde: • Et fald i bedst korrigeret synsskarphed (BCVA) af ≥30 bogstaver sammenlignet med den sidste bestemmelse af synsstyrken; • Et intraoculært tryk ≥30 mmHg; • En retinal lækage • En subretinal blødning der omfatter centret af fovea, eller hvis størrelsen af blødningen er ≥50% af det totale læsionsareal; • Udførte eller planlagte introculære operationer inden for de foregående eller næste 28 dage.
The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: a decrease in best-corrected visual acuity (BCVA) of ≥ 30 letters compared with the last assessment of visual acuity; an intraocular pressure of ≥ 30 mmHg; a retinal break; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥ 50%, of the total lesion area; performed or planned intraocular surgery within the previous or next 28 days.
Behandlingen bør afbrydes hos individer med rhegmatogen nethindeløsning eller makulært hul i stadium 3 eller 4.
Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
Der er ikke foretaget formelle interaktionsundersøgelser.
No formal interaction studies have been performed.
5. 1.
For the adjunctive use of verteporfin photodynamic therapy (PDT) and Lucentis, see section 5.1.
Graviditet Der foreligger ikke tilstrækkelige data om brugen af ranibizumab hos gravide kvinder.
Pregnancy There are no data from the use of ranibizumab in pregnant women.
Der forefindes ingen dyreforsøg.
There are no animal studies.
Den systemiske eksponering for ranibizumab forventes at være meget lille efter okulær indgivelse, men på grund at dets virkningsmekanisme skal ranibizumab betragtes som potentielt teratogent og embryo - / føtotoksisk.
The systemic exposure to ranibizumab is expected to be very low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/ foetotoxic.
Ranibizumab må derfor ikke anvendes under graviditet, med mindre den forventede fordel ved behandlingen opvejer den potentielle risiko for fosteret.
Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus.
Fødedygtige kvinder Fødedygtige kvinder skal anvende effektiv prævention under behandlingen.
Women of childbearing potential Women of childbearing potential should use effective contraception during treatment.
Amning Det vides ikke, om Lucentis udskilles i human modermælk.
Lactation It is not known whether Lucentis is excreted in human milk.
Under anvendelse af Lucentis frarådes amning.
Breast-feeding is not recommended during the use of Lucentis.
4. 8).
The Lucentis treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8).
I alt 1. 315 patienter udgjorde safety populationen, som blev eksponeret med Lucentis i de tre fase III - forsøg i 24 måneder, og 440 patienter blev behandlet med den anbefalede dosis på 0, 5 mg.
A total of 1,315 patients constituted the safety population in the three phase III studies with 24 months exposure to Lucentis and 440 patients were treated with the recommended dose of 0.5 mg.
4. 4).
Serious adverse events related to the injection procedure included endophthalmitis, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.4).
4. 4).
Other serious ocular events observed among Lucentis-treated patients included intraocular inflammation and increased intraocular pressure (see section 4.4).
4 De hændelser, der er opført herunder, forekom med større hyppighed (mindst 2 procentpoint) hos patienter, der fik behandling med Lucentis 0, 5 mg, end hos patienter, der fik kontrolbehandling (simuleret injektion eller verteporfin- PDT), i tre kontrollerede fase III- forsøg, FVF2598g (MARINA), FVF2587g (ANCHOR) og FVF3192g (PIER).
The adverse events listed below occurred at a higher rate (at least 2 percentage points) in patients receiving treatment with Lucentis 0.5 mg than in those receiving control treatment (sham or verteporfin PDT) in the three controlled phase III studies FVF2598g (MARINA), FVF2587g
Hændelserne blev derfor betragtet som potentielle lægemiddelbivirkninger.
These were therefore considered potential adverse drug reactions.
Sikkerhedsdataene, der er beskrevet herunder, omfatter desuden alle de hændelser (hos mindst 0, 5 procentpoint af patienterne), der er mistænkt for at være mindst muligt relateret til injektionsproceduren eller til produktet hos de 440 patienter i de kombinerede behandlingsgrupper med 0, 5 mg.
The safety data described below also include all adverse events (in at least 0.5 percentage points of patients) suspected to be at least potentially related to the injection procedure or medicinal product in the 440 patients of the combined 0.5 mg treatment groups.
Hændelserne er opført efter organsystemklasse og hyppighed (meget almindelig (≥1/ 10), almindelig (≥1/ 100, < 1/ 10), ualmindelig (≥1/ 1. 000, < 1/ 100), sjælden (≥1/ 10. 000, < 1/ 1. 000) og meget sjælden (< 1/ 10. 000).
The adverse events are listed by system organ class and frequency using the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Undersøgelser Meget almindelige
Investigations Very common
Hovedpine
Very common
Meget almindelig
Eye disorders Very common
Vitrit, corpus vitreum- løsning, nethindeblødning, synsforstyrelse, øjensmerter, mouches volantes, konjunktival blødning, øjenirritation, fornemmelse af fremmedlegeme i øjnene, øget tåreflod, blefarit, tørt øje, okulær hyperæmi, øjenkløe.
Vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperaemia, eye pruritus.
Nethindedegeneration, nethindesygdom, nethindeløsning, retinarift, løsning af retinale pigmentepitel, retinal pigmentepitelrift, nedsat syn, corpus vitreum blødning, corpus vitreum- sygdom, uveit, irit, iridocyklit, katarakt, nukleær katarakt, opacifikation af bageste kapsel, punktformet keratit, hornhindeabrasion, lysvej i forreste kammer, sløret syn, blødninger ved injektionsstedet, øjen blødninger, konjunctivitis, konjunctivitis allergi, udflåd, lysfornemmelser som flimren, fotofobi, okulært ubehag, øjenlågsødem, øjenlågsirritation, øjenlågssmerter, konjunktival hyperæmi.
Retinal degeneration, retinal disorder, retinal detachment, retinal tear, detachment of the retinal pigment epithelium, retinal pigment epithelium tear, visual acuity reduced, vitreous haemorrhage, vitreous disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior capsule opacification, punctuate keratitis, corneal abrasion, anterior chamber flare, vision blurred, injection site haemorrhage, eye haemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photopsia, photophobia, ocular discomfort, eyelid oedema, eyelid pain, conjunctival hyperaemia.
Meget almindelig
Musculoskeletal and connective tissue disorders Very common
5 Infektioner og parasitære sygdomme Meget almindelig
Infections and infestations
Næsesvælgrumskatar
Very common
Immunsystemet
Nasopharyngitis
Almindelig
Immune system disorders Common Psychiatric disorders
Hypersensitivitet
Hypersensitivity 5
Psykiske forstyrrelser Almindelig
Common
Produkt- klasse- relaterede bivirkninger:
Product-class-related adverse reactions:
I fase III studierne var den samlede frekvens af ikke - okulære blødninger, en bivirkning som potentielt er relateret til VEGF - (vaskulær endothelial vækstfaktor) hæmning svagt øget hos ranibizumabbehandlede patienter.
In the phase III studies, the overall frequency of non-ocular haemorrhages, an adverse event potentially related to systemic VEGF (vascular endothelial growth factor) inhibition, was slightly increased in ranibizumab-treated patients.
Der er en teoretisk risiko for arterielle tromboemboliske hændelser ved intravitreal anvendelse af VEGF inhibitorer.
There is a theoretical risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Selvom, der er observeret en lav forekomst af arterielle tromboemboliske tilfælde i de kliniske stuider med Lucentis, så var der ingen ubalance i de behandlede grupper.
A low incidence rate of arterial thromboembolic events was observed in the Lucentis clinical trials and there were no major differences between the treatment groups.
Tilfælde af overdosis givet ved uheld er blevet indberettet fra de kliniske forsøg og fra post- marketing data.
Cases of accidental overdose have been reported from the clinical studies and post-marketing data.
Antineovaskulære midler, ATC- kode:
Antineovascularisation agents, ATC code:
Ranibizumab er et humaniseret rekombinant monoklonalt antistoffragment rettet mod human vaskulær endotelial vækstfaktor A (VEGF- A).
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A).
Det binder sig med høj affinitet til isoformer af VEGF- A (f. eks.
It binds with high affinity to the VEGF-A isoforms (e. g.
VEGF110, VEGF121 og VEGF165), hvorved det forhindrer binding af VEGF- A til dets receptorer VEGFR- 1 og VEGFR- 2.
VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Binding af VEGF- A til dets receptorer medfører endotelial celleproliferation og neovaskularisering samt vaskulær lækage, som alt sammen menes at bidrage til progressionen af den neovaskulære form af aldersrelateret maculadegeneration.
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.
Den kliniske sikkerhed og effekt af Lucentis er blevet vurderet i tre randomiserede, dobbeltblinde forsøg med simuleret injektionskontrol eller aktiv kontrol hos patienter med neovaskulær AMD.
The clinical safety and efficacy of Lucentis have been assessed in three randomised, double-masked, sham- or active-controlled studies in patients with neovascular AMD.
I alt 1. 323 patienter (879 aktiv og 444 kontrol) blev indrulleret i disse forsøg.
A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
I forsøg FVF2598g (MARINA) fik patienter med minimalt klassisk CNV eller okkult og ingen klassisk choroidal neovaskularisation (CNV) månedlige intravitreale injektioner af Lucentis 0, 3 mg eller 0, 5 mg eller simuleret injektioner.
In study FVF2598g (MARINA), patients with minimally classic or occult with no classic choroidal neovascularisation (CNV) received monthly intravitreal injections of Lucentis 0.3 mg or 0.5 mg or sham injections.
240).
A total of 716 patients were enrolled in this study (sham, 238; Lucentis 0.3 mg, 238; Lucentis 0.5 mg, 240).
Data er tilgængelige frem til udgangen af måned 24.
Data are available up to the end of month 24.
I forsøg FVF2587g (ANCHOR) fik patienter med overvejende klassiske CNV- læsioner enten:
In study FVF2587g (ANCHOR), patients with predominantly classic CNV lesions received either: