FrancophonIA/ELRC3.0 huggingface dataset:
English: - Prevention and treatment of postoperative pain and inflammation associated with cataract surgery - Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients (see section 5.1)
Danish: - Forebyggelse og behandling af postoperativ smerte og inflammation forbundet med kataraktoperation - Reduktion af risikoen for postoperativt makulært ødem med kataraktkirurgi hos patienter med diabetes (se pkt.
English: The most frequently reported adverse reaction was punctate keratitis which occurred in 1% of patients, resulting in a frequency category of common.
Danish: Den hyppigst indberettede bivirkning var punktformet keratitis, som optrådte hos 1 % af patienterne, og som blev klassificeret under kategorien ”Almindelig”.
English: The most frequently reported adverse reaction was punctate keratitis which occurred in 3% of patients, resulting in a frequency category of common.
Danish: Den hyppigst rapporterede bivirkning var punktformet keratitis, som optrådte hos 3 % af patienterne, og som blev klassificeret under kategorien ”Almindelig”.
English: In two double-masked, randomised vehicle-controlled studies, patients treated with NEVANAC had significantly less inflammation (aqueous cells and flare) in the early postoperative period through the end of treatment than those treated with its vehicle.
Danish: I 2 randomiserede, dobbeltblinde vehikelkontrollerede studier havde patienterne i NEVANACgruppen væsentligt mindre inflammation (celler og flare i kammervæske) i den tidlige postoperative periode til endt behandling end patienterne i vehikel-gruppen.
English: The other most frequently reported adverse reactions were keratitis and foreign body sensation in eyes which occurred in 0.5% and 0.3% of patients, respectively both adverse reactions with a frequency category of uncommon.
Danish: De øvrige hyppigst indberettede bivirkninger var keratitis og fornemmelse af fremmedlegeme i øjet, som optrådte hos hhv. 0,5 % og 0,3 % af patienterne og blev klassificeret under kategorien ”Ikke almindelig”.
English: - complicated eye surgery - repeated eye surgery within a short period of time - certain disorders of the surface of the eye, such as inflammation or dry eye - certain general disease, such as diabetes or rheumatoid arthritis
Danish: - gennemgår en kompliceret øjenoperation - gennemgår flere øjenoperationer inden for en kort periode - får visse lidelser i øjets overflade så som en betændelseslignende tilstand (inflammation) eller tørre øjne - får visse generelle sygdomme, så som sukkersyge (diabetes) eller leddegigt
English: In these studies, study medication was initiated the day prior to surgery, continued on the day of surgery and for up to 2-4 weeks of the postoperative period.
Danish: Der fortsattes på operationsdagen og i op til 2-4 uger efter operationen.
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 and prevention of post surgical macular oedema (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 samt forebyggelse af postoperativt makulært ødem (se pkt.
English: Not known: corneal perforation, impaired healing (cornea), corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision
Danish: Ikke kendt: Perforation af cornea, forsinket heling (cornea), opacitet i cornea, ardannelse i cornea, nedsat skarpsyn, hævede øjne, ulcereøs keratitis, udtynding af cornea, sløret syn
English: 1 ml of suspension contains 1 mg nepafenac.
Danish: 1 ml suspension indeholder 1 mg nepafenac.
English: Prevention and treatment of postoperative pain and inflammation associated with cataract surgery Three pivotal studies were conducted to assess the efficacy and safety of NEVANAC dosed 3 times daily as compared to vehicle and/or ketorolac trometamol in the prevention and treatment of postoperative pain and inflammation in patients undergoing cataract surgery.
Danish: 3 pivotale studier blev udført for at vurdere NEVANACs virkning og sikkerhed, når det doseres 3 gange dagligt sammenlignet med vehikel og/eller ketorolactrometamol til forebyggelse og behandling af postoperativ smerte og inflammation hos patienter, der har gennemgået kataraktoperation.
English: In the two clinical studies involving 594 patients, diabetic patients were exposed to NEVANAC eye drops, suspension treatment for 90 days for the prevention of macular oedema post cataract surgery.
Danish: I to kliniske studier med 594 patienter blev patienter med diabetes behandlet med NEVANAC i 90 dage efter kataraktoperation for at forebygge makulært ødem.
English: Novartis Pharma N.V.
Danish: Novartis Pharma B.V.
English: In clinical studies involving 2314 patients receiving NEVANAC 1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.
Danish: I kliniske studier med 2.314 patienter, der blev behandlet med NEVANAC 1 mg/ml øjendråber, var de hyppigste bivirkninger, der forekom hos mellem 0,4 % og 0,2 % af patienterne, punktformet keratitis, fornemmelse af fremmedlegeme i øjet og skorper på øjenlågsranden.
English: Uncommon: keratitis, punctate keratitis, corneal epithelium defect, foreign body sensation in eyes, eyelid margin crusting
Danish: Ikke almindelig: Keratitis, punktat keratit, defekt i corneaepitelet, følelse af fremmedlegeme i øjet, skorper på øjenlågsranden
English: Do not use NEVANAC - if you are allergic to nepafenac or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to other nonsteroidal anti-inflammatory drugs (NSAID) - if you have experienced asthma, skin allergy, or intense inflammation in your nose when using other NSAIDs.
Danish: Brug ikke NEVANAC: - Hvis du er allergisk over for nepafenac eller et af de øvrige indholdsstoffer i NEVANAC (angivet i punkt 6).
English: No toxic effects are likely to occur in case of overdose with ocular use, nor in the event of accidental oral ingestion.
Danish: Der forventes ingen toksisk virkning ved en okulær overdosering.
English: How to use NEVANAC
Danish: Sådan skal du bruge NEVANAC
English: 1 ml of suspension contains 3 mg nepafenac.
Danish: 1 ml suspension indeholder 3 mg nepafenac.
English: The following side effects have been observed with NEVANAC 3 mg/ml eye drops, suspension or NEVANAC 1 mg/ml eye drops, suspension or both.
Danish: Følgende bivirkninger er set i forbindelse med NEVANAC 3 mg/ml øjendråber, suspension eller NEVANAC 1 mg/ml øjendråber, suspension eller begge:
English: The following side effects have also been observed with NEVANAC 1 mg/ml eye drops, suspension or NEVANAC 3 mg/ml eye drops, suspension, or both.
Danish: Følgende bivirkninger er også set i forbindelse med NEVANAC, 1 mg/ml øjendråber, suspension, eller NEVANAC, 3 mg/ml øjendråber, suspension eller begge:
English: Wearing contact lenses is not recommended after cataract surgery.
Danish: Det frarådes at bruge kontaktlinser efter en operation for grå stær (katarakt).
English: In addition, in one of the two clinical trials, NEVANAC 3 mg/ml eye drops, suspension dosed once a day was non-inferior to NEVANAC 1 mg/ml eye drops, suspension dosed three times a day for the prevention and treatment of postoperative pain and inflammation following cataract surgery.
Danish: Desuden var NEVANAC 3 mg/ml øjendråber, suspension administreret én gang dagligt ikke mindre effektivt til forebyggelse og behandling af postoperative smerter og inflammation end NEVANAC 1 mg/ml øjendråber, suspension administreret tre gange dagligt efter kataraktoperation.
English: The adverse reactions were obtained from clinical trials or post-marketing reports with NEVANAC 3 mg/ml eye drops, suspension and NEVANAC 1 mg/ml eye drops, suspension.
Danish: Bivirkningerne er indsamlet fra kliniske undersøgelser og rapporter med NEVANAC 3 mg/ml øjendråber, suspension og NEVANAC 1 mg/ml øjendråber, suspension efter markedsføringen.
English: Rare: iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia
Danish: Sjælden: Irit, koroidal effusion, aflejringer i cornea, øjensmerter, okulært ubehag, tørre øjne, blefarit, øjenirritation, øjenkløe, sekret fra øjet, allergisk konjunktivit, øget tåredannelse, konjunktival hyperæmi.
English: • Effects in the eye: eye surface inflammation with or without loss or damage of cells, foreign body sensation in the eyes, eyelid crusting or drooping.
Danish: • Reaktioner i øjet: Betændelseslignende tilstand (inflammation) på øjets overflade med eller uden celletab eller beskadigelse af celler, fornemmelse af fremmedlegeme i øjet, skorper på øjenlåget eller hængende øjenlåg
English: Four studies (two in diabetic patients and two in non-diabetic patients) were conducted to assess the efficacy and safety of NEVANAC for the prevention of postoperative macular oedema associated with cataract surgery.
Danish: Nedsat risiko for postoperativt makulært ødem forbundet med kataraktoperation hos diabetikere Fire studier (to hos patienter med diabetes og to hos ikke-diabetikere) blev udført for at vurdere NEVANACs virkning og sikkerhed ved forebyggelse af postoperativt makulært ødem efter kataraktoperation.
English: If you are breast-feeding, NEVANAC may pass into your milk.
Danish: Hvis du ammer, kan NEVANAC gå over i mælken, men der forventes ingen påvirkning af det ammede barn.
English: • General side effects: dizziness, headache, allergic symptoms (eyelid allergic swelling), nausea, skin inflammation, redness and itching.
Danish: • Generelle bivirkninger: Svimmelhed, hovedpine, allergiske symptomer (allergisk hævelse af øjenlåg), kvalme, betændelseslignende tilstand (inflammation) i huden, rødme og kløe
English: • Effects in the eye: damage of the surface of the eye such as thinning or perforation, impaired healing of the eye, eye surface scar, clouding, reduced vision, eye swelling, blurred vision.
Danish: • Reaktioner i øjet: skader på øjets overflade, såsom udtynding eller perforering, forsinket heling af øjet, ar på øjets overflade, uklart syn, nedsat syn, hævede øjne, sløret syn.
English: • Effects in the eye: damage on the surface of the eye such as thinning or perforation, impaired healing of the eye, eye surface scar, clouding, reduced vision, eye swelling, blurred vision.
Danish: • Reaktioner i øjet: skader på øjets overflade, såsom udtynding eller perforering, forsinket heling af øjet, ar på øjets overflade, uklart syn, nedsat syn, hævede øjne, sløret syn
English: Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, 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 med topikale NSAID-præparater efter markedsføringen viser, at risikoen for potentielt synstruende bivirkninger i cornea kan være øget hos patienter, der har gennemgået komplicerede øjenoperationer, haft cornea-denervering, defekter i cornea-epitelet, diabetes mellitus, okulære overfladelidelser (f.eks. tørre øjne), reumatoid arthritis eller gennemgået gentagne øjenoperationer inden for en kort periode.
English: Disodium edetate
Danish: edetas.
English: • Effects in the eye: iris inflammation, eye pain, eye discomfort, dry eye, eyelid swelling, eye irritation, itchy eye, eye discharge, allergic conjunctivitis (eye allergy), increased tear production, deposits on the eye surface, fluid or swelling at the back of the eye, eye redness.
Danish: • Reaktioner i øjet: Betændelseslignende tilstand (inflammation) i iris (den farvede del af øjet), øjensmerter, ubehag i øjet, tørre øjne, hævede øjenlåg, øjenirritation, øjenkløe, sekret fra øjet, allergisk konjunktivit (øjenallergi), øget tåreproduktion, aflejringer på øjets overflade, væske eller hævelse på bagsiden af øjet, røde øjne.
English: What NEVANAC is and what it is used for What you need to know before you use NEVANAC How to use NEVANAC
Danish: Det skal du vide, før du begynder at bruge NEVANAC Sådan skal du bruge NEVANAC Bivirkninger
English: NEVANAC 3 mg/ml eye drops, suspension
Danish: NEVANAC 3 mg/ml øjendråber, suspension
English: For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician.
Danish: Til nedsættelse af risikoen for makulært ødem efter kataraktoperation hos patienter med diabetes er dosis 1 dråbe NEVANAC i konjunktivalsækken i det/de pågældende øje/øjne 3 gange dagligt med start dagen før kataraktoperationen.
English: NEVANAC 1 mg/ml eye drops, suspension
Danish: NEVANAC 1 mg/ml øjendråber, suspension
English: For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) once daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician.
Danish: Til nedsættelse af risikoen for makulært ødem efter kataraktoperation hos patienter med diabetes er dosis 1 dråbe NEVANAC i konjunktivalsækken i det/de pågældende øje/øjne 1 gang dagligt med start dagen før kataraktoperationen.
English: Do not store above 30˚C.
Danish: Må ikke opbevares ved temperaturer over 30 ºC.
English: NEVANAC 1 mg/ml eye drops, suspension nepafenac
Danish: NEVANAC 1 mg/ml øjendråber, suspension nepafenac
English: NEVANAC 3 mg/ml eye drops, suspension nepafenac
Danish: NEVANAC 3 mg/ml øjendråber, suspension nepafenac
English: For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period.
Danish: Til forebyggelse og behandling af smerte og inflammation er dosis 1 dråbe NEVANAC i konjunktivalsækken i det/de pågældende øje/øjne 3 gange dagligt med start dagen før kataraktoperationen.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med NEVANAC Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Do not store above 25˚C.
Danish: Må ikke opbevares ved temperaturer over 25 ºC.
English: - complicated eye surgery - repeated eye surgery within a short period of time - certain disorders of the surface of the eye, such as inflammation or dry eye - certain general diseases, such as diabetes or rheumatoid arthritis.
Danish: Der kan være en øget risiko for bivirkninger i hornhinden (øjeæblets overflade), hvis du: - gennemgår en kompliceret øjenoperation - gennemgår flere øjenoperationer inden for en kort periode - får visse lidelser i øjets overflade så som en betændelseslignende tilstand (inflammation) eller tørre øjne - får visse generelle sygdomme, såsom sukkersyge (diabetes) eller leddegigt
English: • After cap is removed, if a tamper evident snap collar is present and is loose, remove before using product.
Danish: • Hvis der sidder en sikkerhedsring omkring hætten, og den sidder løst, når flasken åbnes, skal den fjernes, inden præparatet tages i brug.
English: For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) once a day beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period.
Danish: Til forebyggelse og behandling af smerte og inflammation er dosis 1 dråbe NEVANAC i konjunktivalsækken i det/de pågældende øje/øjne én gang dagligt med start dagen før kataraktoperationen.
English: NEVANAC 3 mg/ml eye drops nepafenac
Danish: NEVANAC 3 mg/ml øjendråber nepafenac
English: After cap is removed, if a tamper evident snap collar is present and is loose, remove before using product.
Danish: Hvis der sidder en sikkerhedsring omkring hætten, og den sidder løst, når flasken åbnes, skal den fjernes, inden præparatet tages i brug.
English: NEVANAC 1 mg/ml eye drops nepafenac
Danish: NEVANAC 1 mg/ml øjendråber nepafenac
English: Posology
Danish: POSE
English: • Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Danish: • Hold spidsen af flasken tæt hen til øjet.
English: België/Belgique/Belgien
Danish: België/Belgique/Belgien Novartis Pharma N.V.
English: Do not use NEVANAC - if you are allergic to nepafenac or any of the other ingredients of this medicine (listed in section 6), - if you are allergic to other nonsteroidal anti-inflammatory drugs (NSAID) - if you have experienced asthma, skin allergy, or intense inflammation in your nose when using other NSAIDs.
Danish: - Hvis du har haft astma, hudallergi eller en kraftig betændelseslignende tilstand (inflammation) i næsen ved brug af andre NSAID-præparater.
English: Two studies in diabetic patients were conducted to assess the efficacy and safety of NEVANAC 3 mg/ml eye drops, suspension dosed once a day for the prevention of postoperative macular oedema associated with cataract surgery.
Danish: Nedsat risiko for postoperativt makulært ødem forbundet med kataraktoperation hos diabetikere To studier hos patienter med diabetes blev udført for at vurdere sikkerheden og virkningen af NEVANAC 3 mg/ml øjendråber administreret 1 gang dagligt for at forebygge postoperativt makulært ødem efter kataraktoperation.
English: However, no effects on breast-fed children are anticipated.
Danish: Opbevares utilgængeligt for børn.
English: Breast-feeding
Danish: Dinatriumedetat
English: Nasonex medicinal products are registered in the following EU Members States: Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom and also in Iceland and Norway.
Danish: Nasonex er registreret i følgende EU medlemsstater: Østrig, Belgien, Bulgarien, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige, Det Forenede Kongerige samt i Island og Norge.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 30 i direktiv 2001/83/EF.
English: Nasonex medicinal products are currently not registered in Cyprus.
Danish: Nasonex-lægemidler er på nuværende tidspunkt ikke registreret i Cypern.
English: The content of this section has not been changed from what is approved in most countries although the wordings have in some cases been amended to achieve harmonisation.
Danish: Indholdet i dette punkt er ikke ændret i forhold til det, der er godkendt i de fleste lande; ordlyden er i visse tilfælde dog harmoniseret.
English: Overall summary of the scientific evaluation of Nasonex and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Nasonex og relaterede navne (se bilag I)
English: Nasal polyposis
Danish: Nasal polypose
English: Section 4.5- Interaction with other medicinal products and other forms of interaction
Danish: Punkt 4.5 - Interaktion med andre lægemidler og andre former for interaktion
English: A cross reference to section 4.4 for use with systemic corticosteroids is made.
Danish: Der indsættes en krydshenvisning til punkt 4.4 om anvendelse sammen med systemiske kortikosteroider.
English: It is stated that overdose is unlikely to require any therapy other than observation since the systemic bioavailability of mometasone furoate is <1%.
Danish: Det anføres, at overdosering ikke forventes at kræve anden behandling end observation, da den systemiske biotilgængelighed af mometasonfuroat er <1 %.
English: The safety and efficacy of Nasonex Nasal Spray has not been established in:
Danish: Sikkerheden og virkningen af Nasonex næsespray er ikke fastlagt hos:
English: The text in section 4.2 has been revised and aligned with the QRD requirements.
Danish: Teksten i punkt 4.2 er revideret og rettet ind efter QRD-kravene.
English: The higher incidence of epitaxis observed in clinical studies is also mentioned in this section as well as in section 4.8.
Danish: Den iagttagne højere forekomst af epistaxis i de kliniske undersøgelser nævnes også i dette afsnit foruden i afsnit 4.8.
English: It was authorised according to the national procedure in 16 European countries and according to the mutual recognition procedure (MRP) in 13 Member States, with the United Kingdom (UK) acting as reference Member State (RMS).
Danish: Det blev godkendt ved nationale procedurer i 16 europæiske lande og ved den gensidige anerkendelsesprocedure i 13 medlemsstater med Det Forenede Kongerige som referencemedlemsstat.
English: The adverse events were presented independently of the indication and presenting all data (pooled) in a single tabulated format.
Danish: Bivirkningerne blev beskrevet uafhængigt af indikation, og alle data (poolet) samlet i én enkelt tabel.
English: The overall response in terms of improvement from baseline was shown to be similar between the 3- to 5-year-old and 6- to 11-year-old subgroups.
Danish: Den overordnede respons i form af bedring i forhold til baseline fandtes at være den samme i undergrupperne 3-5 år og 6-11 år.
English: Reference is made to a clinical interaction study was conducted with loratadine where no interactions were reported to have been observed.
Danish: Der henvises til en klinisk interaktionsundersøgelse med loratadin, hvor der ikke iagttoges interaktioner.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Nasonex and associated names, the European Commission (EC) notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the authorised SmPCs for the above-mentioned product, and thus to harmonise the SmPCs across the EU.
Danish: På grund af medlemsstaternes divergerende nationale afgørelser om markedsføringstilladelsen for Nasonex og relaterede navne anmeldte Europa-Kommissionen en officiel indbringelse til EMA's sekretariat i henhold til artikel 30 i direktiv 2001/83/EF med henblik på at ophæve divergenserne mellem de nationalt godkendte produktresuméer for ovennævnte lægemiddel og dermed harmonisere produktresuméerne i EU.
English: No toxicological effects unique to mometasone furoate exposure were demonstrated.
Danish: Der er ikke påvist særskilte toksikologiske virkninger ved eksponering for mometasonfuroat.
English: Subsequently, a study Q97-921 specifically in subjects with perennial non-allergic rhinitis (PNAR) was completed indicating a positive outcome, and resulting in an indication for PNAR being granted in May 2000 in Sweden.
Danish: Efterfølgende fuldførtes undersøgelse Q97921, der specifikt vedrørte personer med tilbagevendende ikke-allergisk rhinitis (PNAR) og fik positivt udfald, resulterende i godkendelse af indikationen PNAR i Sverige i maj 2000.
English: Nasonex is a nasal preparation for topical use and contains benzalkonium chloride.
Danish: Nasonex er et topikalt præparat til nasal anvendelse og indeholder benzalkoniumchlorid.