FrancophonIA/ELRC3.0 huggingface dataset:
English: Amfenac inhibits the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
Danish: Amfenac hæmmer effekten af prostaglandin H-synthase (cyclooxygenase), et enzym, der er nødvendigt for dannelsen af prostaglandiner.
English: Tiny amounts of sodium hydroxide and/or hydrochloric acid are added to keep acidity levels (pH levels) normal.
Danish: Små mængder natriumhydroxid og/eller saltsyre er tilsat for at bevare en normal surhedsgrad (pH-værdi).
English: What NEVANAC contains - The active substance is nepafenac.
Danish: NEVANAC indeholder: - Aktivt stof: nepafenac.
English: In one double-masked, randomised, vehicle and active-controlled study, patients treated with NEVANAC had significantly less inflammation than those treated with vehicle.
Danish: I et randomiseret, dobbeltblindt, vehikel og aktiv-kontrolleret studie havde de patienter, der blev behandlet med NEVANAC, betydeligt mindre inflammation end de patienter, der blev behandlet med vehikel.
English: - if you have any other eye disorder (e.g. an eye infection) or if you are using other medicines in the eye (especially topical steroids).
Danish: - Hvis du har nogen anden øjenlidelse, f.eks. øjenbetændelse, eller hvis du bruger anden medicin til øjet (især binyrebarkhormonøjendråber).
English: Do not use more than one drop in the affected eye(s) 3 times daily.
Danish: Brug ikke mere end 1 dråbe i det/de pågældende øje/øjne 3 gange dagligt.
English: Boric acid
Danish: Borsyre (acid.
English: CARTON FOR SINGLE BOTTLE 5 ml
Danish: KARTON TIL 5 ml ENKELTFLASKER
English: Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Danish: Det er blevet rapporteret, at benzalkoniumchlorid kan medføre punktat keratopati og/eller toksisk ulcerøs keratopati.
English: Clinical trial experience for the long-term use of NEVANAC for the prevention of macular oedema post cataract surgery in diabetic patients is limited.
Danish: Erfaring fra kliniske forsøg med langtidsbrug af NEVANAC til forebyggelse af makulært ødem efter kataraktoperation hos diabetikere er begrænset.
English: • Turn the closed bottle upside down and shake down once before each use.
Danish: • Vend den lukkede flaske på hovedet og ryst den let en enkelt gang inden brug.
English: • Twist off the bottle cap.
Danish: • Skru hætten af flasken.
English: Women who may become pregnant are advised to use effective contraception during NEVANAC treatment.
Danish: Kvinder, der kan blive gravide, skal bruge sikker prævention, mens de er i behandling med NEVANAC.
English: Nevertheless, as inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development.
Danish: Alligevel bør NEVANAC ikke anvendes under graviditet, da hæmning af prostaglandinsyntesen kan have en negativ indvirkning på graviditet og/eller embryo-/fosterudvikling og/eller fødsel og/eller postnatal udvikling.
English: Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs).
Danish: Overfølsomhed over for andre non-steroide antiinflammatoriske stoffer (NSAID-præparater).
English: If you stop using NEVANAC
Danish: Hvis du holder op med at bruge NEVANAC
English: There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
Danish: Der er potentiale for krydssensibilitet mellem nepafenac og acetylsalicylsyre, phenyleddikesyrederivater og andre NSAID-præparater.
English: Patients treated with NEVANAC were less likely to have ocular pain and measurable signs of inflammation (aqueous cells and flare) in the early postoperative period through to the end of treatment than those treated with its vehicle.
Danish: De patienter, der var i behandling med NEVANAC, havde mindre sandsynlighed for øjensmerter og målbare tegn på inflammation (celler og flare i kammervæske) i den tidlige postoperative periode til endt behandling end de patienter, der blev behandlet med dets vehikel.
English: If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Danish: Hvis der opstår sløret syn efter drypning, skal patienten vente med at køre bil eller betjene maskiner, indtil synet er klart igen.
English: The preservative in NEVANAC, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Danish: Konserveringsmidlet i NEVANAC, benzalkoniumchlorid, kan absorberes af bløde kontaktlinser og kan ændre farven af kontaktlinserne.
English: If you forget to use NEVANAC
Danish: Hvis du har glemt at bruge NEVANAC
English: Each ml of suspension contains 0.05 mg of benzalkonium chloride.
Danish: Hver ml suspension indeholder 0,05 mg benzalkoniumchlorid.
English: • General side effects: vomiting, increased blood pressure.
Danish: • Øvrige bivirkninger: opkastning, øget blodtryk
English: Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health.
Danish: Patienter med påvist nedbrydning af cornea-epitelet skal straks ophøre med at bruge NEVANAC, og corneas tilstand skal undersøges nøje.
English: Additionally, NEVANAC was non-inferior to ketorolac 5 mg/ml in reducing inflammation and ocular pain, and was slightly more comfortable upon instillation.
Danish: Sammenlignet med ketorolac 5 mg/ml var NEVANAC ikke mindre effektivt til at reducere inflammation og okulær smerte, og det var en anelse mere behageligt ved instillation.
English: 5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml suspension.
Danish: 5 ml rund polyethylenflaske med lav densitet og med dråbespids og hvidt skruelåg af polypropylen, der indeholder 5 ml suspension.
English: Some patients received NEVANAC 3 mg/ml eye drops, suspension for up to 21 days post operation.
Danish: Nogle patienter fik NEVANAC 3 mg/ml øjendråber, suspension i op til 21 dage efter operationen.
English: Patients should be instructed not to swallow NEVANAC.
Danish: Patienten bør informeres om ikke at indtage NEVANAC oralt.
English: Topical NSAIDs may slow or delay healing.
Danish: Topikale NSAID-præparater kan medføre langsom eller forsinket helingsproces.
English: The mean steady-state plasma Cmax for nepafenac and for amfenac were 0.847 ± 0.269 ng/ml and 1.13 ± 0.491 ng/ml, respectively, following ocular administration.
Danish: Det gennemsnitlige steady-state plasma Cmax for nepafenac og for amfenac var henholdsvis 0,847 ± 0,269 ng/ml og 1,13 ± 0,491 ng/ml efter okulær administration.
English: NEVANAC should not be used by women of child bearing potential not using contraception.
Danish: NEVANAC bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: In integrated analysis of the 2 studies, the percentage of subjects with 15 letter improvement at Day 14 and maintained to Day 90 was higher in NEVANAC 3 mg/ml group (55.4%) compared to vehicle group (46.7%, p=0.003).
Danish: I en integreret analyse af de 2 studier var procentdelen af forsøgsdeltagere med en forbedring på 15 bogstaver på dag 14, og som opretholdt den til dag 90, højere i NEVANAC 3 mg/mlgruppen (55,4 %) end i vehikel-gruppen (46,7 %, p=0,003).
English: Round or oval low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 3 ml suspension.
Danish: Rund eller oval polyethylenflaske med lav densitet og med dråbespids og hvidt skruelåg af polypropylen, der indeholder 3 ml suspension.
English: More patients treated with NEVANAC achieved a 15 letter improvement in BCVA compared to vehicle patients, 56.8% compared to 41.9%.
Danish: Flere patienter behandlet med NEVANAC opnåede en forbedring på 15-bogstaver i BCVA sammenlignet med vehikel-patienter, henholdsvis 56,8 % sammenlignet med 41,9 %, p=0,019.
English: Write the date of opening on the carton label in the space provided.
Danish: Skriv åbningsdatoen, hvor der er gjort plads til dette på kartonen.
English: The mean steady-state plasma Cmax for nepafenac and for amfenac were 0.310 ± 0.104 ng/ml and 0.422 ± 0.121 ng/ml, respectively, following ocular administration.
Danish: Det gennemsnitlige steady-state plasma Cmax for nepafenac og for amfenac var henholdsvis 0,310 ± 0,104 ng/ml og 0,422 ± 0,121 ng/ml efter okulær administration.
English: Use a single dose as soon as you remember.
Danish: Hvis du har glemt en dosis, så tag den så snart du kommer i tanker om det.
English: NEVANAC 3 mg/ml eye drops, suspension is indicated in adults for:
Danish: NEVANAC 3 mg/ml øjendråber, suspension er indiceret til voksne til:
English: After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug.
Danish: Efter topikal okulær dosering penetrerer nepafenac cornea og omdannes af hydrolaser i det okulære væv til amfenac, et non-steroidt antiinflammatorisk middel.
English: Results from clinical studies indicate that NEVANAC 3 mg/ml eye drops, suspension have no significant effect on intraocular pressure.
Danish: Resultater fra kliniske studier viser, at NEVANAC 3 mg/ml øjendråber, suspension ikke har nogen signifikant indflydelse på det intraokulære tryk.
English: Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
Danish: Samtidig brug af topikale NSAID-præparater og topikale steroider kan øge den potentielle risiko for helingsproblemer.
English: This medicine contains 0.25 mg benzalkonium chloride in each 5 ml which is equivalent to 0.05 mg/ml.
Danish: Dette lægemiddel indeholder 0,25 mg benzalkoniumchlorid pr. 5 ml svarende til 0,05 mg/ml.
English: NEVANAC can be used during breast-feeding.
Danish: NEVANAC kan anvendes under amning.
English: Use of topical NSAIDs may result in keratitis.
Danish: Brug af topikale NSAID-præparater kan forårsage keratitis.
English: Following 3 times daily dosing of NEVANAC eye drops in both eyes, low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours post-dose, respectively.
Danish: Efter dosering af NEVANAC øjendråber 3 gange dagligt i begge øjne, blev der observeret lave men kvantificerbare plasmakoncentrationer af nepafenac og amfenac hos hovedparten af patienterne henholdsvis 2 og 3 timer efter dosering.
English: This medicine contains 0.15 mg benzalkonium chloride in each 3 ml which is equivalent to 0.05 mg/ml.
Danish: Dette lægemiddel indeholder 0,15 mg benzalkoniumchlorid pr. 3 ml svarende til 0,05 mg/ml.
English: Patients with evidence of corneal epithelial breakdown including corneal perforation should immediately discontinue use of NEVANAC and should be monitored closely for corneal health (see section 4.4).
Danish: Patienter med tegn på nedbrydning af cornea-epitelet, herunder perforation af cornea, skal straks seponere NEVANAC, og corneas tilstand skal overvåges nøje (se pkt.
English: For storage conditions after first opening of the medicinal product, see section 6.3
Danish: Opbevaringsforhold efter anbrud af lægemidlet, se pkt.
English: A significantly greater percentage of patients achieved improvement of 15 or more letters at Day 14 and maintained the improvement through Day 90 in NEVANAC 3 mg/ml group (61.7%) compared to vehicle group (43%) in one study; the percentage of subjects was similar in the 2 treatment groups for this endpoint in the second study (48.8% in NEVANAC group and 50.5% in vehicle group).
Danish: I det ene studie opnåede en signifikant større procentdel af patienterne i NEVANAC 3 mg/ml-gruppen (61,7 %) en forbedring på 15 eller flere bogstaver på dag 14 og opretholdt forbedringen til og med dag 90 sammenlignet med vehikel-gruppen (43 %); i det andet studie var procentdelen af forsøgsdeltagere, der opnåede endepunkt, sammenlignelig i de 2 behandlingsgrupper (48,8 % i NEVANAC-gruppen og 50,5 % i vehikel-gruppen).
English: Do not use more than one drop in the affected eye(s).
Danish: Brug ikke mere end 1 dråbe i det/de pågældende øje/øjne.
English: Contact lens wear is not recommended during the postoperative period following cataract surgery.
Danish: Brugen af kontaktlinser frarådes i den postoperative periode efter en kataraktoperation.
English: In both double-masked, randomised vehicle-controlled studies, conducted in diabetic retinopathy patients, a significantly greater percentage of patients in the vehicle group developed macular oedema (17.3% and 14.3%) compared to patients treated with NEVANAC 3 mg/ml (2.3% and 5.9%).
Danish: I begge de dobbeltblinde, randomiserede, vehikel-kontrollerede studier, der blev udført hos diabetespatienter med retinopati, udviklede en signifikant højere procentdel af patienterne i vehikelgruppen makulært ødem (17,3 % og 14,3 %) sammenlignet med de patienter, der blev behandlet med NEVANAC 3 mg/ml (2,3 % og 5,9 %).
English: Do not swallow or inject.
Danish: Det må ikke anvendes gennem munden eller til injektion.
English: Prevention and treatment of postoperative pain and inflammation associated with cataract surgery The efficacy and safety of NEVANAC 3 mg/ml in the prevention and treatment of postoperative pain and inflammation associated with cataract surgery has been demonstrated in two masked, double blind, placebo-controlled clinical trials in a total of 1339 patients.
Danish: Virkning og sikkerhed af NEVANAC 3 mg/ml til forebyggelse og behandling af postoperativ smerte og inflammation forbundet med kataraktoperation er vist i to maskerede, dobbeltblinde, placebokontrollerede kliniske forsøg med i alt 1.339 patienter.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er de alvorligste bivirkninger anført først.
English: In clinical studies involving over 1900 patients receiving NEVANAC 3 mg/ml eye drops, suspension, the most frequently reported adverse reactions were punctate keratitis, keratitis, foreign body sensation in eyes and eye pain which occurred in between 0.4% and 0.1% of patients.
Danish: I kliniske studier med 1.900 patienter, der blev behandlet med NEVANAC 3 mg/ml øjendråber, suspension, var de hyppigst indberettede bivirkninger punktformet keratitis, keratitis, fornemmelse af fremmedlegemer i øjet og smerter i øjet, hvilket forekom hos mellem 0,4 % og 0,1 % af patienterne.
English: This may be up to 3 weeks (to prevent and relieve eye pain and inflammation) or 60 days (to prevent the development of macular oedema and to improve vision) after your operation.
Danish: Det kan være op til 3 uger (for at forebygge og lindre øjensmerter og betændelseslignende tilstande (inflammation)) eller 60 dage (for at forebygge hævelse i den bageste del af øjet (makulært ødem) og forbedre synet) efter operationen.
English: Following one drop of NEVANAC 3 mg/ml eye drops, suspension in both eyes once daily for four days, low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours post-dose, respectively.
Danish: Efter én dråbe NEVANAC 3 mg/ml øjendråber, suspension i begge øjne én gang dagligt i fire dage, blev der observeret lave men kvantificerbare plasmakoncentrationer af nepafenac og amfenac hos hovedparten af patienterne henholdsvis 2 og 3 timer efter dosering.
English: Write the date of opening on the bottle and carton label in the space provided.
Danish: Skriv åbningsdatoen, hvor der er gjort plads til dette på flaskens etiket og på kartonen.
English: - The other ingredients are benzalkonium chloride (see section 2), carbomer, disodium edetate, mannitol, purified water, sodium-chloride and tyloxapol.
Danish: - Øvrige indholdsstoffer: benzalkoniumchlorid (se afsnit 2), carbomer, dinatriumedetat, mannitol, renset vand, natriumchlorid og tyloxapol.
English: In 1 double-masked, randomised vehicle-controlled study, conducted in diabetic retinopathy patients, a significantly greater percentage of patients in the vehicle group developed macular oedema (16.7%) compared to patients treated with NEVANAC (3.2%).
Danish: I et dobbeltblindt, randomiseret vehikel-kontrolleret studie, der blev udført hos diabetespatienter med retinopati, udviklede en signifikant højere procentdel af patienterne i vehikel-gruppen makulært ødem (16,7 %) sammenlignet med de patienter, der blev behandlet med NEVANAC (3,2 %).
English: Concomitant use of NEVANAC with medications that prolong bleeding time may increase the risk of haemorrhage (see section 4.4).
Danish: Samtidig anvendelse af NEVANAC og andre lægemidler, som forlænger blødningstiden, kan øge risikoen for blødning (se pkt.
English: Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
Danish: Hos patienter, hvor acetylsalicylsyre eller andre NSAID-præparater kan fremkalde astmaanfald, urticaria eller akut rhinitis.
English: From post-marketing experience with NEVANAC, cases reporting corneal epithelium defect/disorder have been identified.
Danish: Efter markedsføring af NEVANAC er der rapporteret tilfælde af defekt/sygdom i cornea-epitelet.
English: If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart.
Danish: Ved anvendelse af mere end ét topikalt øjenlægemiddel skal indgivelsen af de forskellige lægemidler foregå med mindst 5 minutters mellemrum.
English: What NEVANAC looks like and contents of the pack NEVANAC eye drops, suspension (eye drops) is a liquid (light yellow to dark orange suspension) supplied in a plastic bottle with a screw cap. Each bottle may be placed in a pouch.
Danish: NEVANAC øjendråber, suspension (øjendråber) er en væske (lys gul til mørk orange suspension), der fås i en plasticflaske med skruelåg.
English: Manufacturer S.A. Alcon - Couvreur N.V Rijksweg 14
Danish: S.A. Alcon - Couvreur N.V Rijksweg 14
English: The other reported adverse reactions were corneal epithelium defect and allergic dermatitis which occurred in 1% and 0.5% of patients, respectively both adverse reactions with a frequency category of uncommon.
Danish: De øvrige rapporterede bivirkninger var defekter i cornea-epitelet og allergisk dermatitis, som optrådte hos hhv. 1 % og 0,5 af patienterne og blev klassificeret under kategorien ”Ikke almindelig”.
English: Therefore, it is recommended that caution should be exercised if NEVANAC is administered concomitantly with corticosteroids, particularly in patients at high risk for corneal adverse reactions described below.
Danish: Derfor anbefales det at udvise forsigtighed, hvis NEVANAC administreres samtidig med kortikosteroider.
English: Treatment can be extended to the first 3 weeks of the postoperative period, as directed by the clinician.
Danish: Behandling kan forlænges til 3 uger efter operationen, som foreskrevet af lægen.
English: This may be up to 3 weeks (to prevent and relieve eye pain and inflammation) or 60 days (to prevent the development of macular oedema) after your operation.
Danish: Det kan være op til 3 uger (for at forebygge og lindre øjensmerter og betændelseslignende tilstande (inflammation)) eller 60 dage (for at forebygge hævelse i den bageste del af øjet (makulært ødem)) efter operationen.
English: In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation (see section 4.8).
Danish: Hos særligt følsomme patienter kan vedvarende brug af topikale NSAID-præparater resultere i epitel-nedbrydning, tynd cornea, corneaerosion, -ulceration eller -perforation (se pkt.
English: What you need to know before you use NEVANAC
Danish: Det skal du vide, før du begynder at bruge NEVANAC
English: Once-daily dosing with NEVANAC 3 mg/ml eye drops, suspension provides the same total daily dose of nepafenac as three-times-daily dosing with NEVANAC 1 mg/ml eye drops, suspension.
Danish: Administration én gang dagligt med NEVANAC 3 mg/ml øjendråber, suspension giver samme totale daglige dosis nepafenac som administration tre gange dagligt med NEVANAC 1 mg/ml øjendråber, suspension.
English: • Shake well before use.
Danish: • Omrystes grundigt inden brug.
English: NEVANAC contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses.
Danish: NEVANAC indeholder benzalkoniumchlorid, der kan medføre øjenirritation og misfarvning af bløde kontaktlinser.
English: - The other ingredients are boric acid, propylene glycol, carbomer, sodium chloride, guar, carmellose sodium, disodium edetate, benzalkonium chloride (see section 2) and purified water.
Danish: - Øvrige indholdsstoffer: borsyre, propylenglycol, carbomer, natriumchlorid, guar, carmellosenatrium, dinatriumedetat, benzalkoniumchlorid (se afsnit 2) og renset vand.
English: In the two clinical studies involving 209 patients, diabetic patients were exposed to NEVANAC treatment for 60 days or greater for the prevention of macular oedema post cataract surgery.
Danish: I to kliniske studier med 209 patienter blev patienter med diabetes behandlet med NEVANAC i 60 dage eller derover efter kataraktoperation for at forebygge makulært ødem.
English: Light yellow to light orange uniform suspension, pH 7.4 (approximately).
Danish: Øjendråber, suspension Lys gul til lys orange homogen suspension, pH ca. 7,4.
English: Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions.
Danish: Langvarig anvendelse af topikale NSAID-præparater kan øge risikoen for, at der opstår alvorlige bivirkninger i cornea.
English: From post-marketing experience with NEVANAC 1 mg/ml eye drops, suspension, cases reporting corneal epithelium defect/disorder have been identified.
Danish: Efter markedsføring af NEVANAC 1 mg/ml øjendråber, suspension er der rapporteret tilfælde af defekt/sygdom i cornea-epitelet.
English: The European Medicines Agency has waived the obligation to submit the results of studies with NEVANAC in all subsets of the paediatric population in prevention and treatment of post operative pain and inflammation associated with cataract surgery (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med NEVANAC i alle undergrupper af den pædiatriske population med henblik på forebyggelse og behandling af postoperativ smerte og inflammation forbundet med kataraktoperation (se pkt.
English: What NEVANAC looks like and the contents of the pack NEVANAC is a liquid (light yellow to light orange suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap.
Danish: NEVANAC er en væske (lys gul til lys orange suspension), der fås i en 5 ml plasticflaske med skruelåg.
English: NEVANAC is to be used by adults: - to prevent and relieve eye pain and inflammation following cataract surgery on the eye - to reduce the risk of macular oedema (swelling in the back of the eye) following cataract surgery on the eye in diabetic patients.
Danish: NEVANAC er beregnet til voksne: - til at forebygge og lindre smerter og betændelseslignende tilstande (inflammation) i øjet efter en operation for grå stær (katarakt) - til at nedsætte risikoen for makulært ødem (hævelse i den bageste del af øjet) efter en operation for grå stær (katarakt) hos patienter med sukkersyge (diabetes).
English: In clinical trials, patients were treated for up to 21 days with NEVANAC 3 mg/ml eye drops, suspension (see section 5.1).
Danish: I kliniske forsøg blev patienterne behandlet med NEVANAC 3 mg/ml øjendråber, suspension i 21 dage (se pkt.
English: Contact your doctor immediately if your eyes become more red or more painful whilst using the drops.
Danish: Hvis dine øjne bliver mere røde, eller hvis smerterne forværres, mens du bruger dråberne, skal du straks kontakte din læge.