FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions were classified according to 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).
Danish: Følgende bivirkninger blev klassificeret i henhold til følgende konvention: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10,000).Inden for hver enkelt frekvensgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
English: Czech Republic czech.info@valeant.com
Danish: Tjekkiet czech.info@valeant.com
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Czech Republic
Danish: Tjekkiet
English: You can also report side effects directly via the national reporting system listed in Appendix V.
Danish: Du eller dine pårørende kan også indberette bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Studies in rabbits using radio-labelled bromfenac have demonstrated that highest concentrations after topical administration are observed in the cornea followed by the conjunctiva and the aqueous humour.
Danish: Studier hos kaniner med radiomærket bromfenac har påvist, at de højeste koncentrationer efter topikal administration observeres i cornea efterfulgt af konjunktiva og kammervæsken.
English: Yellox should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time.
Danish: Yellox skal bruges med forsigtighed hos patienter med kendt blødningstendens eller patienter, som modtager andre lægemidler, der kan forlænge blødningstiden.
English: Sodium sulphite, anhydrous (E221) Tyloxapol
Danish: Natriumsulfit, vandfrit (E221) Tyloxapol
English: - Close the bottle cap firmly immediately after use.
Danish: - Luk flaskehætten godt straks efter brug.
English: Yellox contains sodium sulphite and benzalkonium chloride
Danish: Yellox indeholder natriumsulfit og benzalkoniumchlorid
English: Discard any unused contents 4 weeks after first opening.
Danish: Eventuelt ubrugt lægemiddel kasseres 4 uger efter første åbning.
English: The recommended dose is one drop of Yellox in the affected eye(s) twice daily (morning and evening).
Danish: Den anbefalede dosis er én dråbe Yellox i det/de opererede øje/øjne to gange daglig (morgen og aften).
English: - Gently squeeze the bottle to release one drop of Yellox.
Danish: - Tryk forsigtigt på flasken, så der frigives én dråbe Yellox.
English: Each ml of solution contains 50 micrograms of benzalkonium chloride.
Danish: Hver ml opløsning indeholder 50 mikrogram benzalkoniumchlorid.
English: The IC50values were lower for Bromfenac (1.1 μM) than for indometacin (4.2 μM) and pranoprofen (11.9 μM) Bromfenac at concentrations of 0.02%, 0.05%, 0.1% and 0.2% inhibited almost all signs of ocular inflammation in an experimental uveitis model in rabbits.
Danish: IC50-værdierne var lavere for bromfenac (1,1 μM) end for indometacin (4,2 μM) og pranoprofen (11,9 μM) Ved koncentrationer på 0,02 %, 0,05 %, 0,1 % og 0,2 % hæmmede bromfenac næsten alle tegn på okulær inflammation i en eksperimentel uveitis-model hos kaniner.
English: Concomitant use of NSAIDs and topical steroids may increase the potential for healing problems.
Danish: Samtidig brug af NSAID og topiale steroider kan øge muligheden for helingsproblemer.
English: Foreign body sensation in the eye, redness and inflammation of the eye, damage and inflammation of the surface of the eye, eye discharge, itching, irritation or pain of the eye, swelling or bleeding of the eyelid, impaired vision due to inflammation, floaters or moving spots before the eyes or diminishing vision that can indicate bleeding or damage of the back of the eye (retina), ocular discomfort, sensitivity to light, reduced or blurred vision, swelling of the face, cough, nosebleeding or runny nose.
Danish: Følelse af at have et fremmedlegeme i øjet, rødme og betændelse i øjet, skade og betændelse i øjets overflade, pus i øjet, kløe, irritation eller smerte i øjet, hævelse eller blødning i øjenlåget, nedsat syn pga. betændelse, flydere eller bevægende pletter for øjnene eller nedsat syn, der kan være tegn på blødning eller skade på øjets bagside (retina), ubehag i øjet, lysoverfølsomhed, nedsat eller sløret syn, hævelse af ansigtet, hoste, næseblødning eller løbende næse.
English: One drop contains approximately 33 micrograms bromfenac.
Danish: En dråbe indeholder ca. 33 mikrogram bromfenac.
English: - if you have bleeding problems (e.g. haemophilia) or have had them in the past, or you are taking other medicines which may prolong bleeding time (e.g. warfarin, clopidogrel, acetylsalicylic acid).
Danish: - Hvis du har blødningsproblemer (f.eks. hæmofili), eller har haft det tidligere, eller hvis du tager anden medicin, som kan forlænge blødningstiden (f.eks. warfarin, clopidogrel,
English: - if you are allergic to bromfenac or to any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for bromfenac eller et af de øvrige indholdsstoffer i Yellox (angivet i afsnit 6).
English: Cross-sensitivity
Danish: Krydssensitivitet
English: Ocular infection An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products.
Danish: Okulær infektion En akut okulær infektion kan maskeres af t brug af topikale anti-inflammatoriske lægemidler.
English: Animal studies have shown excretion of bromfenac in breast milk when applied orally at doses of 2.35 mg/kg which is 2350 times the recommended ophthalmic dose.
Danish: Dyreforsøg har vist udskillelse af bromfenac i brystmælk ved oral anvendelse ved doser på 2,35 mg/kg, hvilket er 2350 gange den anbefalede oftalmiske dosis.
English: Do not use Yellox while wearing contact lenses, since benzalkonium chloride is known to discolour them.
Danish: Brug ikke Yellox med kontaktlinser i øjnene, da det vides, at benzalkoniumchlorid misfarver dem..
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FLASKEETIKET
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Yellox, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Postmarketing experience
Danish: Erfaring efter markedsføring
English: Contents of the pack and other information What Yellox contains
Danish: Pakningsstørrelser og yderligere oplysninger Yellox indeholder:
English: - Keep the bottle tightly closed when not in use.
Danish: - Flasken skal opbevares tæt tillukket, når den ikke er i brug.
English: If you use any other eye drops, wait at least five minutes between using Yellox and the other drops.
Danish: Vent mindst fem minutter mellem brug af Yellox og andre dråber, hvis du bruger andre øjendråber.
English: Yellox contains sodium sulphite which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible patients.
Danish: Yellox indeholder natriumsulfit, der kan medføre allergilignende reaktioner, inklusive anafylaktiske symptomer og livstruende eller mindre alvorlige astmatiske episoder hos følsomme patienter.
English: The dose is one drop of Yellox in the affected eye(s) twice daily, beginning the next day after cataract surgery and continuing through the first 2 weeks of the postoperative period.
Danish: Dosis er en dråbe Yellox i det/de opererede øje/øjne to gange daglig, med start dagen efter kataraktoperationen og fortsættelse i de første 2 uger af den postoperative periode.
English: Therefore, do not wear contact lenses whilst using Yellox.
Danish: Derfor må du ikke bruge kontaktlinser mens du bruger Yellox.
English: Pregnancy , breastfeeding and fertility
Danish: Graviditet, amning og frugtbarhed
English: If blurred vision occurs at instillation patients should be advised to refrain from driving or using machines until vision is clear.
Danish: Hvis sløret syn forekommer ved drypning, skal patienterne rådgives til at undlade at føre motorkøretøjer eller betjene maskiner, indtil synet er klart.
English: If you experience blurred vision upon instillation, do not drive or use machines until your vision is clear.
Danish: Hvis du oplever sløret syn efter inddrypning af Yellox, må du ikke føre motorkøretøjer eller betjene maskiner, før dit syn er klart.
English: Yellox is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other medicinal products with prostaglandin synthetase inhibiting activity.
Danish: Yellox er kontraindiceret hos patienter, hvor anfald af astma, urticaria eller akut rhinitis fremkaldes af acetylsalicylsyre eller af andre lægemidler med prostaglandinsyntetase-hæmmende effekt.
English: Susceptible persons
Danish: Følsomme personer
English: Transient blurring of vision may occur on instillation.
Danish: Forbigående sløret syn kan forekomme ved drypning.
English: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
Danish: Der er mulighed for krydssensitivitet over for acetylsalicylsyre, fenylacetinsyre-derivater og andre NSAID.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Yellox in all subsets of the paediatric population in postoperative ocular inflammation (see section 4.2 for information on paediatric use)
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Yellox hos alle undergrupper af den pædiatriske population ved postoperativ okulær inflammation (se pkt.
English: The most common or most important reactions in the pooled studies were abnormal sensation in eye (0.5%), corneal erosion (mild or moderate) (0.4%), eye pruritus (0.4%), eye pain (0.3%) and eye redness (0.3%).
Danish: De mest almindelige eller de mest vigtige bivirkninger i de poolede studier var unormal følelse i øjet (0,5 %), erosion af kornea (mild eller moderat) (0,4 %), øjenkløe (0,4 %), øjensmerter (0,3 og øjenrødme (0,3 %).
English: Ask your pharmacist how to throw away of medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: - Bring the bottle tip close to the eye. - Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Danish: - Undgå at berøre øjet eller øjenlåget, de omgivende områder eller andre overflader med dråbetælleren.
English: There was significantly less anterior chamber cells and flare within the first 2 weeks post-surgery (85.1% of patients with flare score of ≤1) vs. placebo (52%).
Danish: Der var signifikant færre celler i forreste kammer og ”flare” inden for de første 2 uger efter kirurgi (85,1 % af patienter med flare-score på ≤1) vs. placebo (52 %) Forskellen i hastigheden for inflammationsophør viste sig allerede ved dag 3.
English: There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaema) in conjunction with ocular surgery.
Danish: Det er rapporteret, at okulær NSAID kan medføre øget blødning i øjenvæv (inklusive hyphæma) i forbindelse med øjenoperationer.
English: Do not use more than one drop in the affected eye(s) 2 times daily.
Danish: Brug ikke mere end én dråbe i det/de opererede øje/øjne 2 gange daglig.
English: If Yellox is accidentally swallowed, a glass of water or other fluid should be taken to water down the medicine.
Danish: Hvis Yellox synkes ved et uheld, skal der indtages et glas vand eller anden væske for at fortynde medicinen.
English: - The other ingredients are: boric acid, borax, sodium sulphite anhydrous (E221), benzalkonium chloride (see section 2), tyloxapol, povidone (K30), disodium edetate, water for injection, sodium hydroxide (to keep acidity levels normal).
Danish: - Øvrige indholdsstoffer: Borsyre, borax, vandfrit natriumsulfit (E221), benzalkoniumchlorid (se afsnit 2), tyloxapol, povidon (K30), dinatriumedetat, vand til injektion, natriumhydroxid (for at holde syreniveauerne normale).
English: Animal studies have shown excretion of bromfenac in the milk of rats following very high oral doses (see section 5.3).
Danish: Dyreforsøg har vist udskillelse af bromfenac i mælken hos rotter efter meget høje orale doser (se pkt.
English: - Benzalkonium chloride is a preservative which may cause eye irritation or eye surface problems.
Danish: - Benzalkoniumchlorid er et konserveringsmiddel, der kan medføre øjenirritation eller problemer med øjets overflade.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMTAFFALD HERAF
English: - Tilt your head back.
Danish: - Bøj hovedet bagover.
English: Boric acid, borax, sodium sulphite anhydrous (E221) (see the package leaflet for further information), tyloxapol, povidone, disodium edetate, benzalkonium chloride (see the package leaflet for further information), water for injections, sodium hydroxide (for pH adjustment)
Danish: Borsyre, borax, vandfrit natriumsulfit (E221) (se yderligere oplysninger i indlægssedlen), tyloxapol, povidon, dinatriumedetat, benzalkoniumchlorid (se indlægssedlen for yderligere oplysninger), vand til injektioner, natriumhydroxid (til pH-justering)
English: In susceptible patients, continued use of topical NSAIDs, including bromfenac may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation.
Danish: Hos følsomme patienter kan fortsat brug af lokaltvirkende NSAID, inklusive bromfenac, resultere i epitelnedbrydning, udtynding af kornea, erosion af kornea, ulceration af kornea eller perforation af kornea.
English: Benzalkonium chloride is known to discolour soft contact lenses.
Danish: Det vides, at benzalkoniumchlorid misfarver bløde kontaktlinser.
English: Only low concentrations were observed in the lens and vitreous.
Danish: Der blev kun observeret lave koncentrationer i linsen og corpus vitreum.
English: 5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap.
Danish: 5 ml opløsning i en trykbar polyethylen-flaske med en dråbetællerspids og et skruelåg af polyethylen.
English: However, following ocular administration plasma levels were not detectable (see section 5.2).
Danish: Plasmaniveauer var imidlertid ikke påviselige efter okulær administration (se pkt.
English: Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus and ocular surface diseases e.g. dry eye syndrome, rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening.
Danish: Erfaring efter markedsføring med topikal NSAID antyder, at patienter med komplicerede okulære operationer, denervering af cornea, epiteldefekter i cornea, diabetes mellitus og sygdomme i den okulære overflade, f.eks. ”dry eye syndrome”, rheumatoid arthritis eller gentagne øjenoperationer inden for et kort tidsrum kan have øget risiko for bivirkninger i cornea, som kan true synet.
English: What you need to know before you use Yellox Do not use Yellox
Danish: Det skal du vide, før du begynder at bruge Yellox Brug ikke Yellox
English: In general, contact lens wear is not recommended during the postoperative period following cataract surgery.
Danish: Generelt kan det ikke anbefales at bruge kontaktlinser i den postoperative periode efter kataraktkirurgi.
English: Adverse reactions rarely led to withdrawal, with a total of 8 (0.8%) patients who prematurely discontinued treatment in a study due to an adverse reaction.
Danish: I alt 8 (0,8 %) patienter ophørte med behandlingen i studiet for tidligt pga. en bivirkning.
English: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to bromfenac is negligible.
Danish: Der forventes ingen påvirkning af nyfødte/spædbørn, ammet af mødre i behandling med bromfenac, da den systemiske eksponering er ubetydelig.
English: If you stop using Yellox
Danish: Hvis du holder op med at bruge Yellox
English: These comprised 3 (0.3%) patients with mild corneal erosion, 2 (0.2%) patients with eyelid oedema and 1 (0.1%) patient each with abnormal sensation in eye, corneal oedema, or eye pruritus.
Danish: Disse patienter omfattede 3 (0,3 %) patienter med mild erosion af kornea, 2 (0,2 %) patienter med øjenlågsødem og 1 (0,1 %) patient med unormal følelse i øjet, ødem i kornea eller øjenkløe.
English: eye drops, solution 1x5 ml
Danish: øjendråber, opløsning 1 x 5 ml
English: No effects of bromfenac on the fertility were observed in animal studies.
Danish: Dyreforsøg påviste ingen virkninger af bromfenac på fertiliteten.
English: MedDRA system organ Frequency
Danish: Systemorganklasser i henhold til MedDRA
English: Yellox is used to reduce eye inflammation following cataract surgery in adults.
Danish: Yellox bruges til at reducere øjenbetændelse efter kataraktoperation hos voksne.
English: Benzalkonium chloride has been reported to cause eye irritation, punctuate keratopathy and/or toxic ulcerative keratopathy.
Danish: Det er rapporteret, at benzalkoniumchlorid kan medføre øjenirritation, punktformet keratopati og/eller toksisk ulcerativ keratopati.
English: Other medicines and Yellox
Danish: Brug af anden medicin sammen med Yellox
English: If you forget to use Yellox
Danish: Hvis du har glemt at bruge Yellox
English: Patients with evidence of corneal epithelial breakdown should be instructed to immediately discontinue use of Yellox and should be monitored closely for corneal health (see section 4.4).
Danish: Patienter med tegn på epitelnedbrydning i kornea skal instrueres i øjeblikkeligt at ophøre med brug af Yellox, og kornea skal nøje overvåges (se pkt.
English: Yellox can be used during breast-feeding.
Danish: Yellox kan anvendes under amning.
English: Consequently in at risk patients concomitant use of ophthalmic corticosteroids with NSAIDs may lead to a higher risk of corneal adverse events.
Danish: Hos risikopatienter kan samtidig brug af oftalmologiske korticosteroider og NSAID derfor medføre en højere risiko for uønskede hændelser i cornea.
English: If Yellox is accidentally ingested, fluids should be taken to dilute the medicinal product.
Danish: Hvis Yellox ved et uheld, indtages oralt, skal der bruges væske til at fortynde medicinen.
English: Package leaflet: Information for the user Yellox 0.9 mg/ml eye drops, solution
Danish: Indlægsseddel: Information til brugeren Yellox 0,9 mg/ml øjendråber, opløsning
English: Retinal exudates
Danish: Retinaeksudat
English: Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
Danish: Patienter med tegn på epitelnedbrydning i kornea skal øjeblikkeligt ophøre med brug af topikal NSAID ,og korneas tilstand skal nøje overvåges.
English: Yellox is indicated in adults for the treatment of postoperative ocular inflammation following cataract extraction .
Danish: Yellox er indiceret til voksne til behandling af postoperativ okulær inflammation efter kataraktekstraktion.
English: All topical NSAIDs may slow or delay healing like topical corticosteroids.
Danish: Alle topikale NSAID kan lige som topikale kortikosteroider hæmme eller forsinke heling.
English: However, because of the known effects of prostaglandin biosynthesis-inhibiting medicinal products on the foetal cardiovascular system (closure of ductus arteriosus), the use of Yellox during third trimester pregnancy should be avoided.
Danish: Brug af Yellox i graviditetens tredje trimester skal dog undgås pga. de kendte effekter af prostaglandin biosyntese-hæmmende lægemidler på fosterets kardiovaskulære system (lukning af ductus arteriosus).
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Boric acid
Danish: acetylsalicylsyre).
English: Visual acuity reduced Haemorrhagic retinopathy Corneal epithelium defect** Corneal erosion (mild or moderate) Corneal epithelium disorder Corneal oedema
Danish: Ikke almindelig Nedsat synsstyrke Hæmoragisk retinopati Epiteldefekt i kornea** Erosion i kornea (mild eller moderat) Epitelsygdom i kornea Korneaødem
English: In addition the systemic exposure to bromfenac is negligible; for this reason no pregnancy testing or contraceptive measures are required.
Danish: Af denne årsag er graviditetsprøve eller kontraception ikke påkrævet.
English: If you experience decreased or blurred vision the week after the end of treatment, contact your doctor immediately.
Danish: Kontakt din læge øjeblikkeligt, hvis du får nedsat eller sløret syn ugen efter behandlingens afslutning.
English: Corneal perforation* Corneal ulcer* Corneal erosion, serious* Scleromalacia* Corneal infiltrates* Corneal disorder * Corneal scar*
Danish: Korneaperfusion* Sår på kornea* Erosion i kornea, alvorlig* Skleromalaci* Infiltrater i kornea* Sygdom i kornea* Ar på kornea*
English: Benzalkonium chloride Disodium edetate
Danish: Benzalkoniumchlorid Dinatriumedetat
English: In vitro, bromfenac inhibited the synthesis of prostaglandins in the rabbit iris ciliary body.
Danish: Bromfenac hæmmede in vitro prostaglandinsyntesen i corpus ciliare i iris hos kaniner.
English: Hepatic and renal impairment Yellox has not been studied in patients with hepatic disease or renal impairment.
Danish: Yellox er ikke undersøgt hos patienter med leversygdom eller nyrefunktionsnedsættelse.
English: Patients should be instructed to keep the bottle tightly closed when not in use.
Danish: Må ikke opbevares ved temperaturer over 25 C. Patienterne bør instrueres i at opbevare flasken tæt tillukket, når den ikke er i brug.
English: The safety and efficacy of bromfenac in paediatric patients has not been established.
Danish: Bromfenacs sikkerhed og virkning hos børn er ikke klarlagt.
English: Clinical efficacy
Danish: Klinisk virkning og sikkerhed
English: If you notice any of the following side effects while using the drops, contact your doctor immediately:
Danish: Kontakt straks din læge, hvis du bemærker en af følgende bivirkninger, mens du bruger øjendråberne.
English: 1 ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate).
Danish: 1 ml opløsning indeholder 0,9 mg bromfenac (i form af natriumsesquihydrat).
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: Det skal undgås at berøre øjenlåg, omgivende områder eller andre overflader med flaskens dråbetællerspids for at forebygge kontamination af dråbetællerspidsen og opløsningen.
English: One ml of solution contains 0.9°mg bromfenac (as sodium sesquihydrate).
Danish: En ml opløsning indeholder 0,9 mg bromfenac (i form af natriumsesquihydrat).
English: In rare cases upon withdrawal of Yellox, a flare-up of the inflammatory response, e.g. in the form of retina swelling, due to the cataract operation has been observed.
Danish: I sjældne tilfælde er der ved behandlingsophør med Yellox blevet observeret en opblussen af det inflammatoriske respons, f.eks. i form af hævelse af nethinden, efter operation for grå stær.
English: Eye drops, solution.
Danish: Øjendråber, opløsning.