FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pack contains one bottle of 3 ml.
Danish: Hver pakning indeholder en flaske med 3 ml
English: Nepafenac and amfenac were not quantifiable in the urine.
Danish: Nepafenac og amfenac kunne ikke kvantificeres i urinen.
English: B-2870 Puurs
Danish: 2870 Puurs
English: Carton containing 1 bottle.
Danish: Karton som indeholder 1 flaske.
English: Topical NSAIDs should be used with caution in these patients.
Danish: Topikale NSAID-præparater skal bruges med forsigtighed hos disse patienter.
English: One drop in the affected eye or eyes, three times a day - morning, midday, and evening.
Danish: 1 dråbe i det/de pågældende øje/øjne 3 gange dagligt - morgen, middag og aften.
English: Studies in rats have shown that radioactive labelled active substance-related materials distribute widely in the body following single and multiple oral doses of
Danish: Studier i rotter har vist, at radioaktivt mærkede, aktive, substansrelaterede stoffer distribueres vidt i kroppen efter én eller flere orale doser af
English: After oral administration of
Danish: Efter oral indtagelse af
English: The safety and efficacy of NEVANAC in children and adolescents have not been established.
Danish: NEVANACs sikkerhed og virkning hos børn og unge er ikke klarlagt.
English: Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration.
Danish: Nepafenac elimineres primært gennem biotransformation, og den systemiske eksponering er meget lav efter topikal okulær administration.
English: Only use NEVANAC for your eyes.
Danish: Brug kun NEVANAC i øjet.
English: Since the systemic exposure in non-pregnant women is negligible after treatment with NEVANAC, the risk during pregnancy could be considered low.
Danish: Da den systemiske eksponering hos ikke-gravide kvinder er ubetydelig efter behandling med NEVANAC, kan risikoen under graviditet anses for lav.
English: Do not use NEVANAC unless clearly indicated by your doctor.
Danish: Du må ikke bruge NEVANAC, medmindre det er klart angivet af din læge.
English: These side effects have been observed in up to 1 in 100 people.
Danish: Disse bivirkninger er set hos op til 1 ud af 100 patienter.
English: Since NEVANAC contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Danish: Da NEVANAC indeholder benzalkoniumchlorid, er tæt overvågning påkrævet ved hyppig eller langvarig anvendelse.
English: In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions (see section 5.2).
Danish: In vitro-studier har vist, at potentialet for interaktion med andre lægemidler og proteinbindende interaktioner er meget lavt (se pkt.
English: Also tell your doctor if you are taking medicines that reduce blood clotting (warfarin) or other NSAIDs.
Danish: Fortæl det også til lægen, hvis du tager lægemidler, som nedsætter blodets størkningsevne (warfarin) eller NSAID-præparater.
English: Your doctor will advise you when you can use contact lenses again (see also “NEVANAC contains benzalkonium chloride”).
Danish: Din læge vil fortælle dig, når du må bruge kontaktlinser igen (se også ”NEVANAC indeholder benzalkoniumchlorid”).
English: The adverse reactions were obtained from clinical trials and post-marketing reports.
Danish: Bivirkningerne er indsamlet fra kliniske undersøgelser og rapporter efter markedsføringen.
English: Animal studies have shown excretion of nepafenac in the milk of rats.
Danish: Dyrestudier har vist, at nepafenac udskilles i mælken hos rotter.
English: • Pull down your lower eyelid with a clean finger, until there is a ‘pocket' between the eyelid and your eye.
Danish: • Træk ned i det nederste øjenlåg med en ren finger, indtil der dannes en ”lomme” mellem det nedre øjenlåg og dit øje.
English: If you are pregnant, or might get pregnant, talk to your doctor before you use NEVANAC.
Danish: Hvis du er eller kan blive gravid, skal du kontakte din læge, inden du bruger NEVANAC.
English: Studies in rabbits demonstrated that the topically administered nepafenac is distributed locally from the front of the eye to the posterior segments of the eye (retina and choroid).
Danish: Studier med kaniner viste, at topikalt administreret nepafenac distribueres lokalt fra forsiden af øjet til øjets posteriore segment (retina og choroidea).
English: There are no adequate data regarding the use of nepafenac in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af nepafenac til gravide kvinder.
English: NEVANAC should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time.
Danish: NEVANAC bør anvendes med forsigtighed hos patienter med kendt blødningstendens eller som får andre lægemidler, der kan forlænge blødningstiden.
English: Not known: blood pressure increased
Danish: Ikke kendt: Forhøjet blodtryk
English: Throw away the bottle 4 weeks after first opening, to prevent infections.
Danish: Kassér flasken 4 uger efter åbning, for at forhindre infektioner.
English: If you are using other eye drops, wait at least five minutes between using NEVANAC and the other drops.
Danish: Hvis du bruger andre øjenlægemidler, så vent mindst 5 minutter mellem NEVANAC og de andre lægemidler.
English: Severity of these cases vary from non serious effects on the epithelial integrity of the corneal epithelium to more serious events where surgical interventions and/or medical therapy are required to regain clear vision.
Danish: Sværhedsgraden af disse tilfælde varierer fra ikke-alvorlige virkninger på den epiteliale integritet af cornea-epitelet til mere alvorlige bivirkninger, hvor der kræves kirurgisk indgreb og/eller medicinsk behandling for at genvinde et klart syn.
English: The majority of hydrolytic conversion is in the retina/choroid followed by the iris/ciliary body and cornea, consistent with the degree of vascularised tissue.
Danish: Hovedparten af den hydrolytiske omdannelse foregår i retina/choroidea efterfulgt af iris/corpus ciliare og cornea svarende til graden af vaskulariseret væv.
English: Rare side effects (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 patienter)
English: Radiochromatographic analyses before and after β-glucuronidase hydrolysis indicated that all metabolites were in the form of glucuronide conjugates, with the exception of amfenac.
Danish: Radiokromatografiske analyser før og efter β-glucuronidasehydrolyse viste, at alle metabolitter var i form af glukuronidkonjugater, dog med undtagelse af amfenac.
English: CARTON FOR SINGLE BOTTLE
Danish: KARTON TIL ENKELTFLASKE
English: Interactions with other medicinal products: Neither nepafenac nor amfenac inhibit any of the major human cytochrome P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 and 3A4) metabolic activities in vitro at concentrations up to 3000 ng/ml.
Danish: Interaktion med andre lægemidler: Hverken nepafenac eller amfenac hæmmer nogen af de vigtigste metaboliske aktiviteter af det humane cytokrom P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 og 3A4) in vitro ved koncentrationer op til 3000 ng/ml.
English: Pain free rates in the NEVANAC group were 89% and 91% compared to 40% and 50% of patients on vehicle.
Danish: Smertefrihed i NEVANAC-gruppen var 89 % og 91 % sammenlignet med 40 % og 50 % af patienterne på vehikel.
English: Do not stop using NEVANAC without speaking to your doctor first.
Danish: Du må ikke holde op med at bruge NEVANAC uden først at informere din læge.
English: You may find that your vision is blurred temporarily just after using NEVANAC.
Danish: Du kan opleve, at dit syn bliver midlertidigt sløret lige efter, at du har brugt NEVANAC.
English: Considering their mechanism of action, the concomitant use of these medicinal products is not recommended.
Danish: På grund af virkningsmekanismen frarådes samtidig brug af disse lægemidler.
English: It is unknown whether nepafenac is excreted in human milk.
Danish: Det vides ikke, om nepafenac udskilles i human mælk.
English: There may be a higher risk of corneal side effects (eye surface problems) if you have:
Danish: Der kan være en øget risiko for bivirkninger i hornhinden (øjeæblets overflade), hvis du:
English: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Danish: Der kan opstå forbigående sløret syn eller andre synsforstyrrelser, som kan påvirke evnen til at køre bil eller betjene maskiner.
English: Amfenac was the major metabolite in plasma, representing approximately 13% of total plasma radioactivity.
Danish: Amfenac var den hyppigste metabolit i plasma, og udgjorde cirka 13 % af den totale plasmaradioaktivitet.
English: Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Danish: Indehaver af markedføringstilladelsen Novartis Europharm Limited Vista Building
English: NEVANAC is not recommended during pregnancy.
Danish: NEVANAC anbefales ikke under graviditet.
English: In rabbits, nepafenac has been shown to inhibit blood-retinal-barrier breakdown, concomitant with suppression of PGE2 synthesis.
Danish: Hos kaniner er det vist, at nepafenac hæmmer nedbrydning af blod-retina-barrieren samtidig med, at PGE2-syntesen supprimeres.
English: No dose adjustment is warranted in these patients.
Danish: Det er ikke påkrævet at justere dosis hos disse patienter.
English: There are very limited data on the concomitant use of prostaglandin analogues and NEVANAC.
Danish: Der foreligger meget begrænsede data vedrørende samtidig brug af prostaglandinanaloger og NEVANAC.
English: Nepafenac undergoes relatively rapid bioactivation to amfenac via intraocular hydrolases.
Danish: Nepafenac gennemgår en relativ hurtig bioaktivering til amfenac via intraokulære hydrolaser.
English: NEVANAC can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
Danish: NEVANAC kan påvirke eller påvirkes af andre lægemidler, som du tager, herunder andre øjendråber til behandling af grøn stær (glaukom).
English: • Gently squeeze the sides of the bottle until one drop is released into your eye (picture 2).
Danish: • Tryk let på siden af flasken, indtil en dråbe frigives og drypper ned i øjet (billede 2).
English: Cross-sensitivity
Danish: Krydssensibilitet
English: Side effects with frequency not known (frequency cannot be estimated from the available data)
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (hyppigheden kan ikke bestemmes ud fra tilgængelige data)
English: Subsequently, amfenac undergoes extensive metabolism to more polar metabolites involving hydroxylation of the aromatic ring leading to glucuronide conjugate formation.
Danish: Derefter gennemgår amfenac en omfattende metabolisme til mere polære metabolitter, der involverer hydroxylering af den aromatiske ring, som fører til dannelse af glukuronidkonjugat.
English: NEVANAC has no or negligible influence on the ability to drive and use machines.
Danish: NEVANAC påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Purified water
Danish: Natriumhydroxid og/eller saltsyre (til justering af pH) Renset vand
English: Amfenac has a high affinity toward serum albumin proteins.
Danish: Amfenac har en høj affinitet over for serumalbumin proteiner.
English: Side effects with frequency not known (cannot be estimated from the available data)
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (kan ikke bestemmes ud fra tilgængelige data)
English: System organ classification
Danish: Systemorganklasse
English: Ocular adverse reactions in diabetic patients may occur at a higher frequency than observed in the general population (see section 4.4).
Danish: Okulære bivirkninger kan forekomme med højere frekvens hos diabetikere end observeret i den generelle befolkning (se pkt.
English: Uncommon: hypertension Not known: blood pressure increased
Danish: Ikke almindelig: Hypertension Ikke kendt: Forhøjet blodtryk
English: In pregnant rabbits, a maternal dose of 30 mg/kg that produced slight toxicity in the mothers showed a statistically significant increase in the incidence of litter malformations.
Danish: Hos drægtige kaniner viste en maternel dosis på 30 mg/kg, som fremkaldte let toksicitet hos mødrene, en statistisk signifikant stigning i forekomsten af misdannelser hos fostre.
English: The corresponding percentages in integrated analysis of the 2 studies were 15.9% in vehicle group and 4.1% in NEVANAC group, p<0.001).
Danish: De tilsvarende procenter i en integreret analyse af de 2 studier var 15,9 % i vehikel-gruppen og 4,1 % i NEVANAC-gruppen, p<0,001).
English: The second most abundant plasma metabolite was identified as 5-hydroxy nepafenac, representing approximately 9% of total radioactivity at Cmax.
Danish: Den næsthyppigste plasmametabolit blev identificeret som 5-hydroxy-nepafenac, og udgjorde cirka 9 % af den totale radioaktivitet ved Cmax.
English: If it is almost time for the next dose, leave out the missed dose and continue with the next dose of your regular routine.
Danish: Hvis du snart skal tage den næste dosis, så spring den glemte dosis over og fortsæt efter den sædvanlige doseringsplan.
English: To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Danish: For at undgå kontaminering af øjendråbeflaskens spids og suspensionen skal man være opmærksom på ikke at berøre øjenlåget, omgivende områder eller andre overflader med spidsen af flasken.
English: If contact lenses need to be used during treatment, patients should be advised to remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
Danish: Hvis det er nødvendigt at bruge kontaktlinser under behandling, bør patienterne instrueres om at fjerne kontaktlinserne før applikation, og vente mindst 15 minutter efter drypning, før linserne sættes i igen.
English: Prostaglandin analogues
Danish: Prostaglandinanaloger
English: Eye ointments should be administered last.
Danish: Øjensalver skal påføres til sidst.
English: The recommended dose is One drop in the affected eye or eyes, once a day.
Danish: Den anbefalede dosis er 1 dråbe i det/de pågældende øje/øjne én gang dagligt.
English: Rare: dizziness, headache
Danish: Sjælden: Svimmelhed, hovedpine
English: Rare: hypersensitivity
Danish: Sjælden: Overfølsomhed
English: Talk to your doctor, pharmacist or nurse before using NEVANAC: - if you bruise easily or have bleeding problems or have had them in the past.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger NEVANAC: - Hvis du let får blå mærker, eller du har blødningsproblemer eller har haft det tidligere.
English: In the two studies, NEVANAC cleared inflammation at day 14 post operation in 65% and 68% of patients compared to 25% and 35% of patients on vehicle.
Danish: I de to forsøg fjernede NEVANAC inflammation på dag 14 efter operationen hos 65 % og 68 % af patienterne sammenlignet med 25 % og 35 % af patienterne på vehikel.
English: These events may be sight threatening.
Danish: Disse tilstande kan være synstruende.
English: In reproduction studies performed with nepafenac in rats, maternally toxic doses ≥10 mg/kg were associated with dystocia, increased postimplantation loss, reduced foetal weights and growth, and reduced foetal survival.
Danish: I reproduktionsstudier med nepafenac hos rotter var maternelle toksiske doser ≥10 mg/kg forbundet med dystoci, øget post-implantation tab, reduceret fostervægt og -vækst og nedsat fosteroverlevelse.
English: NSAIDs do not have any antimicrobial properties.
Danish: NSAID-præparater har ingen antimikrobielle egenskaber.
English: Topical corticosteroids are also known to slow or delay healing.
Danish: Topikale kortikosteroider er også kendt for at medføre langsom eller forsinket helingsproces.
English: Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac.
Danish: Eksempler på NSAID-præparater er: acetylsalicylsyre, ibuprofen, ketoprofen, piroxicam, diclofenac.
English: Rare: nausea Not known: vomiting
Danish: Sjælden: Kvalme Ikke kendt: Opkastning
English: A significantly higher percentage of patients in the NEVANAC group reported no ocular pain following cataract surgery compared to those in the vehicle group.
Danish: En signifikant højere procentdel af patienterne i NEVANAC-gruppen rapporterede ingen okulær smerte efter kataraktoperation, sammenlignet med patienterne i vehikel-gruppen.
English: When nepafenac is prescribed to a diabetic patient post cataract surgery to prevent macular oedema, the existence of any additional risk factor should lead to reassessment of the foreseen benefit/risk and to intensified patient monitoring.
Danish: Når nepafenac ordineres til en patient med diabetes til forebyggelse af makulært ødem efter kataraktoperation, skal tilstedeværelse af eventuelle yderligere risikofaktorer føre til en revurdering af mulige fordele/risici samt intensiveret overvågning af patienten.
English: An acute ocular infection may be masked by the topical use of anti-inflammatory medicines.
Danish: En akut okulær infektion kan maskeres ved topikal anvendelse af antiinflammatoriske præparater.
English: If a dose is missed, a single drop should be applied as soon as possible before reverting to regular routine.
Danish: Hvis en dosis glemmes, appliceres en enkelt dråbe så hurtigt som muligt, og derefter følges den sædvanlige doseringsplan.
English: Following a single dose of NEVANAC in 25 cataract surgery patients, aqueous humour concentrations were measured at 15, 30, 45 and 60 minutes post-dose.
Danish: Efter en enkelt dosis NEVANAC i 25 patienter, som alle havde fået foretaget en kataraktoperation, blev koncentrationen i kammervæske målt 15, 30, 45 og 60 minutter efter dosering.
English: The medicinal product should not be injected.
Danish: Dette lægemiddel må ikke injiceres.
English: In case of ocular infection, their use with anti-infectives should be undertaken with care.
Danish: I tilfælde af en okulær infektion skal brugen af disse sammen med anti-infektiva overvåges nøje.
English: Its use is not recommended in these patients until further data become available.
Danish: NEVANAC anbefales ikke til disse patienter, før der foreligger yderligere data.
English: Pharmacotherapeutic group: Opthalmologicals, Anti-inflammatory agents, non-steroids, ATC code: S01BC10
Danish: Farmakoterapeutisk klassifikation: Oftalmologiske midler, antiinflammatoriske stoffer, non-steroide, ATC-kode: S01BC10
English: This may be a result of inflammation on the eye surface with or without loss or damage of cells or an inflammation of the coloured part of the eye (iritis).
Danish: Det kan skyldes en betændelseslignende tilstand (inflammation) i øjets overflade med eller uden tab eller beskadigelse af celler, eller en betændelseslignende tilstand (inflammation) i den farvede del af øjet (iritis).
English: NEVANAC 1 mg/ml is indicated in adults for:
Danish: NEVANAC 1 mg/ml er indiceret til voksne til:
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flasken og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There are no data on the effect of NEVANAC on human fertility.
Danish: Der er ingen eller utilstrækkelige data vedrørende NEVANACs virkning på human fertilitet.
English: NEVANAC has not been studied in patients with hepatic disease or renal impairment.
Danish: NEVANAC er ikke undersøgt hos patienter med leversygdom eller nedsat nyrefunktion.
English: Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug.
Danish: Nepafenac er et non-steroid antiinflammatorisk og smertestillende pro-drug.
English: In these studies, study medication was initiated the day prior to surgery, continued on the day of surgery and for up to 90 days of the postoperative period.
Danish: I disse studier blev studiemedicinen administreret dagen før operation, på operationsdagen og i op til 90 dage efter operation.
English: Results from clinical studies indicate that NEVANAC eye drops have no significant effect on intraocular pressure.
Danish: Resultater fra kliniske studier viser, at NEVANAC øjendråber ikke har nogen signifikant indflydelse på det intraokulære tryk.
English: Close the bottle cap firmly immediately after use.
Danish: Luk flasken omhyggeligt umiddelbart efter brug.
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter)
English: There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery.
Danish: Det er rapporteret, at NSAID-præparater til okulær anvendelse kan forårsage øget blødning i det okulære væv (herunder hyphaema) i forbindelse med okulære operationer.
English: However, no effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to nepafenac is negligible.
Danish: Der forventes ingen påvirkning af det ammede barn, da den systemiske eksponering for nepafenac hos den ammende kvinde er ubetydelig.
English: The maximum mean aqueous humour concentrations were observed at the 1 hour time-point (nepafenac 177 ng/ml, amfenac 44.8 ng/ml).
Danish: Den maksimale, gennemsnitlige koncentration i kammervæsken blev observeret efter 1 time (nepafenac 177 ng/ml, amfenac 44,8 ng/ml).
English: Patients should be instructed to avoid sunlight during treatment with NEVANAC.
Danish: Patienterne skal instrueres i at undgå sollys under behandling med NEVANAC.
English: Light yellow to dark orange uniform suspension, pH 6.8 (approximately).
Danish: Lys gul til mørk orange homogen suspension, pH ca. 6,8.
English: C-nepafenac to healthy volunteers, urinary excretion was found to be the major route of radioactive excretions, accounting for approximately 85% while faecal excretion represented approximately 6% of the dose.
Danish: C-nepafenac til raske frivillige blev det påvist, at størstedelen af radioaktiv udskillelse foregik gennem urinen, og det udgjorde cirka 85 %, mens fækal udskillelse udgjorde cirka 6 % af dosen.
English: A greater percentage of patients treated with vehicle experienced a decrease in BCVA of more than 5 letters from day 7 to day 90 (or early exit) (11.5%) compared with patients treated with nepafenac (5.6%).
Danish: En højere procentdel af de patienter, der blev behandlet med vehikel, oplevede en reduktion af BCVA (best corrected visual acuity) på mere end 5 bogstaver fra dag 7 til dag 90 (eller ved førtidigt ophør) (11,5 %) sammenlignet med de patienter, der blev behandlet med Nepafenac (5,6 %).
English: Ex vivo, a single topical ocular dose of nepafenac was shown to inhibit prostaglandin synthesis in the iris/ciliary body (85%-95%) and the retina/choroid (55%) for up to 6 hours and 4 hours, respectively.
Danish: Ex vivo er det blevet påvist, at en enkelt topikal okulær dosis af nepafenac hæmmer prostaglandinsyntesen i iris/corpus ciliare (85 %-95 %) og i retina/choroidea (55 %) i op til henholdsvis 6 og 4 timer.
English: NEVANAC contains benzalkonium chloride
Danish: NEVANAC indeholder benzalkoniumchlorid
English: Avoid sunlight during treatment with NEVANAC
Danish: - Undgå sollys under behandling med NEVANAC
English: • Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs
Danish: • Tryk ikke på siden af flasken, da den er designet på en sådan måde, at et let tryk i bunden af flasken er alt, der skal til (billede 2).
English: NEVANAC contains the active substance nepafenac, and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Danish: NEVANAC indeholder det aktive stof, nepafenac, og tilhører en gruppe af lægemidler, der kaldes nonsteroide antiinflammatoriske stoffer (NSAID-præparater).