FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of blood pressure elevations may be increased in patients requiring prolonged surgery.
Danish: Risikoen for forhøjelse af blodtrykket kan øges hos patienter, der kræver langvarige kirurgiske indgreb.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke straks efter fortynding, er opbevaringstider og -betingelser indtil anvendelsen på brugerens ansvar.
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningernes hyppighed defineres som følger: 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), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: Pharmacotherapeutic group: {Not yet assigned}, ATC code: {Not yet assigned}
Danish: Farmakoterapeutisk klassifikation: {endnu ikke tildelt}, ATC-kode: {endnu ikke tildelt}
English: These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases.
Danish: Disse episoder, hvoraf nogle var dødelige, forekom normalt hos patienter med allerede eksisterende kardiovaskulære sygdomme.
English: Side effects affecting the eye:
Danish: Bivirkninger, der påvirker øjnene:
English: Your doctor will monitor you for any signs or symptoms of side effects and will treat them if necessary.
Danish: Din læge vil holde øje med eventuelle tegn og symptomer på bivirkninger og behandle disse efter behov.
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks efter fortynding.
English: Do not use if the solution is cloudy, or if it contains particles.
Danish: Brug ikke opløsningen, hvis den er uklar eller hvis den indeholder partikler.
English: - One of the active substances in Omidria can react with several types of anaesthetics.
Danish: - Et af de aktive stoffer i Omidria kan reagere med adskillige typer af bedøvelsesmidler.
English: The population in the trials was 26 to 90 years of age (59% female, 41% male; 80% white, 12% black and 8% other race).
Danish: Populationen i forsøgene var 26 til 90 år gamle (59 % kvinder, 41 % mænd, 80 % hvide, 12 % sorte og 8 % anden race).
English: Ketorolac is excreted in human milk after systemic administration.
Danish: Ketorolac udskilles i human mælk efter systemisk administration.
English: If you are able to become pregnant, you should be using suitable contraception before you are given Omidria.
Danish: Hvis du kan blive gravid, bør du bruge et egnet svangerskabsforebyggende middel, før du får Omidria.
English: As your vision may be affected, you should not drive or use machines until your vision has cleared.
Danish: Eftersom synet kan blive påvirket, bør du ikke køre bil eller betjene maskiner, før dit syn er klart igen.
English: The safety profile of Omidria is based on data from 459 adult patients collected during clinical development obtained in randomised controlled trials.
Danish: Omidrias sikkerhedsprofil er baseret på data fra 459 voksne patienter indsamlet under den kliniske udvikling fra randomiserede kontrollerede forsøg.
English: 4.7 Effects on ability to drive and use machines Omidria can have a major influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Omidria kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: This medicine can have a major influence on the ability to drive and use machines.
Danish: Dette lægemiddel kan have stor virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: Side effects listed below are typically mild to moderate in intensity and usually resolve on their own without any long-term effects.
Danish: De bivirkninger, der er anført herunder, er typisk milde til moderate i intensitet og går normalt over af sig selv uden langsigtede virkninger.
English: Omidria should not be used in children and adolescents below the age of 18 as it has not been studied in these groups.
Danish: Omidria bør ikke bruges til børn og unge under 18 år, da det ikke er blevet undersøgt hos denne aldersgruppe.
English: Tel: +353 (1) 526 6789 Fax: +353 (1) 526 6888 eMail: regulatory@omeros.ie
Danish: Tlf.: +353 (1) 526 6789 Fax: +353 (1) 526 6888 E-mail: regulatory@omeros.ie
English: There are no data from the use of Omidria in pregnant women.
Danish: Der er ingen data fra anvendelse af Omidria hos gravide kvinder.
English: Postoperative pain was evaluated by a self-administered 0-100 mm visual analogue scale (VAS).
Danish: Postoperativ smerte blev evalueret ved hjælp af en selvadministreret 0-100 mm visuel analog skala (VAS).
English: Mydriasis was maintained in the Omidria -treated groups, while the placebo-treated groups experienced progressive constriction of the pupil (see figure).
Danish: Mydriase blev opretholdt i de Omidria-behandlede grupper, mens de placebobehandlede grupper oplevede progressiv konstriktion af pupillen (se figuren).
English: These concentrations are over 10-fold higher than the concentration of each agent administered clinically in patients receiving Omidria.
Danish: Disse koncentrationer er over 10 gange højere, end den koncentration af de to midler der administreres klinisk til patienter, der får Omidria.
English: Side effects affecting the body: Common side effects: - inflammation
Danish: Bivirkninger, der påvirker kroppen: Almindelige bivirkninger: - betændelse
English: Endothelial cell counts were not conducted during the clinical studies.
Danish: Der blev ikke udført endotelcelletællinger i løbet af de kliniske studier.
English: Pupil diameter was measured throughout the surgical procedure.
Danish: Pupildiameteren blev målt under hele det kirurgiske forløb.
English: Hyperthyroidism and unstable cardiovascular disease should be addressed prior to surgery.
Danish: Hyperthyreoidisme og ustabil kardiovaskulær sygdom skal behandles inden det kirurgiske indgreb.
English: Clear, colourless to slightly yellow, solution with a pH: 6.3 ±0.3.
Danish: Klar, farveløs til let gullig opløsning med et pH på: 6,3 ± 0,3.
English: It is not known whether phenylephrine is excreted in human milk.
Danish: Det er ukendt, om phenylephrin udskilles i human mælk.
English: Omidria has not been evaluated in the the absence of standard preoperative mydriatic and anesthetic agents.
Danish: Omidria er ikke blevet evalueret i fravær af standard præoperative mydriatika og anæstetika.
English: Histologic examination in non-clinical toxicology studies demonstrated no treatment-related effects on the cornea and, in clinical trials with Omidria, no detrimental effects were observed on best-corrected visual acuity (BCVA).
Danish: Histologisk undersøgelse i ikke-kliniske toksikologiske studier påviste ingen behandlingsrelaterede virkninger på cornea, og i kliniske forsøg med Omidria observeredes der ingen negativ indvirkning på bedst korrigeret synsskarphed (BCVA).
English: Fifty-three percent of patients had brown irides, 28% had blue irides, and 19% had irides of other colours.
Danish: 53 % af patienterne havde brune øje, 28 % havde blå øjne og 19 % havde en anden øjenfarve.
English: All patients were treated with standardised preoperative topical mydriatic and anaesthetic agents.
Danish: Alle patienterne blev behandlet med standardiserede præoperative lokale mydriatika og anæstetika.
English: Intraocular pressure increased
Danish: Forhøjet intraokulært tryk
English: The most frequently reported adverse reactions were, eye pain (4.8%), anterior chamber inflammation (3.9%), conjunctival hyperaemia (2.2%), photophobia (1.7%), corneal oedema (1.3%) and inflammation (1.3%).
Danish: De hyppigst indberette bivirkninger var øjensmerter (4,8 %), inflammation af det anteriore kammer (3,9 %), konjunktival hyperæmi (2,2 %), fotofobi (1,7 %), corneaødem (1,3 %) og inflammation (1,3 %).
English: SPECIAL STORAGE CONDITIONS Do not store above 25 ˚C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25 °C.
English: For any information about this medicine, please contact the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til indehaveren af markedsføringstilladelsen:
English: Systemic overdose of phenylephrine may cause a rapid rise in blood pressure.
Danish: Systemisk overdosering af phenylephrin kan medføre en hurtig stigning i blodtrykket.
English: The safety and efficacy of Omidria in children below the age of 18 years has not been established.
Danish: Omidrias sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Uncommon side effects: - nausea - pain - headache
Danish: Ikke almindelige bivirkninger: - kvalme - smerter - hovedpine
English: The used vial and any unused irrigation solution must be discarded after single use in accordance with local requirements.
Danish: Det brugte hætteglas og eventuel ubrugt skyllevæske skal kasseres efter en enkelt anvendelse i henhold til lokale retningslinjer.
English: As vision may be temporarily affected following intraocular lens replacement in patients who receive Omidria, patients should be advised not to drive or use machines until vision is clear.
Danish: Eftersom synet kan være midlertidigt påvirket efter intraokulær linseudskiftning hos patienter, som får Omidria, bør disse advares om ikke at føre motorkøretøj eller betjene maskiner, før synet er klart.
English: In the event of phenylephrine overdose, prompt injection of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine, has been recommended.
Danish: I tilfælde af overdosering af phenylephrin anbefales øjeblikkelig injektion af et hurtigtvirkende alfa-adrenergt blokeringsmiddel som f.eks. phentolamin.
English: The efficacy and safety of Omidria was evaluated in two Phase 3, randomised, multicentre, doublemasked, placebo-controlled clinical trials in 808 adult patients undergoing intraocular lens replacement.
Danish: Omidrias virkning og sikkerhed blev evalueret i to randomiserede, multicenter, dobbeltmaskerede, placebokontrollerede kliniske fase 3-forsøg hos 808 voksne patienter, der gennemgik intraokulær linseudskiftning.
English: The magnitude of the mydriatic effect of Omidria may be altered in patients who concurrently receive medicinal products that can affect pupil size, such as opioids (miotics) or non-sedating antihistamines (mydriatics).
Danish: Omfanget af Omidrias mydriatiske effekt kan være ændret hos patienter, som samtidig får lægemidler, der kan påvirke pupilstørrelsen, som f.eks. opioider (miotika eller nonsederende antihistaminer (mydriatika).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Omidria in one or more subsets of the paediatric population in lens therapeutic procedures (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Omidria i en eller flere undergrupper af den pædiatriske population ved terapeutiske linseindgreb (se pkt.
English: Ketorolac plasma concentrations were detected in 11 of 14 patients.
Danish: Der fandtes ketorolac i plasma hos 11 ud af 14 patienter.
English: Store the vial in the original package to protect from light.
Danish: Opbevar hætteglasset i den originale pakning for at beskytte mod lys.
English: Omidria will be given to you in a hospital or clinic by a qualified doctor or surgeon who is specialised in eye surgery.
Danish: Du vil få Omidria på et hospital eller en klinik af en kvalificeret læge eller kirurg med speciale i øjenkirurgi.
English: The maximum concentration observed in this patient was 1.7 ng/mL, occurring after instillation of topical preoperative phenylephrine drops and prior to exposure to Omidria.
Danish: Den maksimale koncentration, der observeredes hos denne patient, var 1,7 ng/ml, som forekom efter instillation af lokale præoperative phenylephrindråber og før eksponering for Omidria.
English: Non-clinical data reported in the literature for the individual components in Omidria revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development.
Danish: De prækliniske data for de individuelle komponenter i Omidria, der har været rapporteret i litteraturen, viste ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Omidria is used in adults to rinse the eye during surgery to implant a new lens (part of the eye that focuses light passing through the pupil to allow you to see clearly).
Danish: Omidria bruges til voksne til at skylle øjet under operation med henblik på indsættelse af en ny linse (den del i øjet, som fokuserer det lys, der passerer igennem pupillen, så du kan se klart).
English: Multipack contains 10 cartons, each carton contains one single-use vial.
Danish: Multipakning, der indeholder 10 kartoner, hver karton indeholder et hætteglas til engangsbrug.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for seks måneder efter godkendelsen.
English: Detectable phenylephrine plasma concentrations were observed in only one of 14 patients.
Danish: Der observeredes kun detekterbare plasmakoncentrationer af phenylephrin hos én ud af 14 patienter.
English: Statistical tests for the change from baseline in pupil diameter (mm) during surgery were carried out with the Cochran-Mantel-Haenszel (CMH) test adjusted for the randomisation strata.
Danish: Statistiske tests for ændringen af pupildiameteren (mm) under indgreb fra baseline blev udført med CMH-test (Cochran-Mantel-Haenszel) justeret for randomiseringsstrata.
English: AUC 12 hour ocular pain VAS score (Co-primary endpoint) [Mean±SD]
Danish: AUC 12-timers okulær smerte VAS-score (co-primært endepunkt) [Middel±SD]
English: What Omidria contains
Danish: Omidria indeholder
English: − The bag must be visually inspected for particulate matter.
Danish: − Posen skal undersøges visuelt for partikler.
English: Talk to your doctor or nurse before Omidria is used if you: - have heart disease - have raised blood pressure - have overactive thyroid glands (hyperthyroidism) - are allergic to acetylsalicylic acid or other painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) - have asthma.
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger Omidria, hvis du: - har en hjertesygdom - har forhøjet blodtryk - har overaktiv skjoldbruskkirtel (hypertyreoidisme) - er allergisk over for acetylsalicylsyre eller andre smertestillende midler fra familien, der kaldes nonsteroide antiinflammatoriske lægemidler (NSAID'er) - har astma.
English: Study 1 Analysis Set (n)
Danish: Studie 1 Analysesæt (n)
English: Once opened the product should be diluted immediately.
Danish: Efter åbning skal lægemidlet fortyndes straks.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use immediately after dilution.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Skal anvendes umiddelbart efter fortynding.
English: Patients with narrow-angle glaucoma.
Danish: Patienter med snævervinklet glaukom.
English: There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using ophthalmic phenylephrine.
Danish: Der har været indberetninger om alvorlige kardiovaskulære reaktioner, herunder ventrikulære arytmier og myokardieinfarker, hos patienter, der bruger oftalmisk phenylephrin.
English: Analysis Set (n)
Danish: Analysesæt (n)
English: Omidria is a medicine used during surgery on the eye.
Danish: Omidria er et lægemiddel, som anvendes i forbindelse med øjenoperation.
English: Adverse reactions reported in patients receiving Omidria were typical postoperative findings and most were mild to moderate in intensity and resolved without intervention or any residual effects.
Danish: De bivirkninger, der blev indberettet hos patienter, som fik Omidria, opstod typisk efter operationen, og de fleste var af mild til moderat intensitet og gik i sig selv uden intervention eller residualeffekter.
English: It contains the active substances phenylephrine and ketorolac.
Danish: Det indeholder de aktive stoffer phenylephrin og ketorolac.
English: Preoperative antibiotic, anaesthetics, corticosteroid, mydriatic, and NSAID eye drops may be administered at the discretion of the treating ophthalmologist.
Danish: Præoperative antibiotika, anæstetika, kortikosteroider, mydriatika og NSAID-øjendråber kan administreres efter den behandlende øjenlæges skøn.
English: Ketorolac is an NSAID that inhibits both cyclooxygenase enzymes (COX1 and COX2), reducing pain and inflammation by decreasing tissue concentrations of prostaglandins resulting from surgical trauma.
Danish: Ketorolac er en NSAID, som hæmmer de to cyclooxygenaseenzymer (COX1 og COX2), og dermed reducerer smerte og inflammation ved at sænke vævskoncentrationen af prostaglandiner, der skyldes kirurgisk traume.
English: The maximum ketorolac concentration seen was 4.2 ng/mL.
Danish: Den maksimale ketorolackoncentration, der sås, var 4,2 ng/ml.
English: Vasoconstriction occurs in the conjunctival circulation and in other ocular vessels to the extent that they are exposed to drug.
Danish: Der opstår vasokonstriktion i det konjunktivale kredsløb og i andre blodkar i øjet i den udstrækning de udsættes for lægemidlet.
English: The active substances are phenylephrine (as hydrochloride) and ketorolac (as trometamol).
Danish: Aktive stoffer: phenylephedrin (som hydroklorid) og ketorolac (som trometamol).
English: Subjects with VAS = 0 at all times Subjects with VAS ≥ 40 at any time Study 2
Danish: Forsøgspersoner med VAS = 0 på alle tidspunkter Forsøgspersoner med VAS ≥ 40 på alle tidspunkter Studie 2
English: In case of accidental intracameral injection of the concentrated solution, the anterior chamber should be evacuated immediately and irrigated with standard ophthalmological irrigation solution.
Danish: I tilfælde af utilsigtet intrakameral injektion af den koncentrerede opløsning skal det anteriore kammer øjeblikkeligt tømmes og skylles med standard oftalmologisk skyllevæske.
English: No formal studies have been conducted with Omidria in patients with renal or hepatic impairment.
Danish: Der er ikke udført formelle studier med Omidria hos patienter med nedsat nyre- eller leverfunktion.
English: Intraocular use.
Danish: Intraokulær anvendelse.
English: No drug-related adverse events or pathological findings were observed, with combinations of phenylephrine and ketorolac in irrigation solution administered at concentrations up to 7200 µM phenylephrine and 900 µM ketorolac.
Danish: Der observeredes ingen lægemiddelrelaterede bivirkninger eller patologiske fund med kombinationer af phenylephrin og ketorolac i skyllevæsker administreret ved koncentrationer op til 7200 µM phenylephrin og 900 µM ketorolac.
English: Intraocular metabolic interactions are unlikely because phenylephrine and ketorolac are removed from the anterior chamber by irrigation during the surgical procedure and by normal aqueous humour circulation postoperatively.
Danish: Intraokulære metaboliske interaktioner er usandsynlige, fordi phenylephrin og ketorolac fjernes fra det anteriore kammer ved skylning under indgrebet og på grund af den normale cirkulation af humor aquosus efter operationen.
English: Concomitant use of phenylephrine and atropine may enhance pressor effects and induce tachycardia in some patients.
Danish: Samtidig brug af phenylephrin og atropin kan øge pressoreffekten og inducere takykardi hos visse patienter.
English: Other medicines and Omidria
Danish: Brug af anden medicin sammen med Omidria
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for intraocular irrigation Multipack: 10 (1 pack of 10) vials
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til intraokulær skyllevæske, opløsning Multipakning: 10 (1 pakning med 10) hætteglas
English: Omidria must be diluted into 500 mL of irrigation solution before use.
Danish: Omidria skal fortyndes med 500 ml skyllevæske før brug.
English: If you are given more Omidria than you should have been Phenylephrine, one of the active substances of Omidria, may cause a rapid rise in blood pressure if too much is given and enough passes into the blood to affect other parts of the body.
Danish: Phenylephrin, der er et af de aktive stoffer i Omidria, kan forårsage en hurtig stigning i blodtrykket, hvis der gives for meget, og der passerer en tilstrækkelig mængde over i blodet til at påvirke andre dele af kroppen.
English: Statistical tests for pain as determined from the 100-mm VAS were carried out with a CMH test adjusted for the randomisation strata.
Danish: Der blev udført statistiske tests for smerte som bestemt ud fra 100 VAS med en CMHtest justeret for randomiseringsstrata.
English: − The bag should be gently inverted in order to mix the solution.
Danish: − Posen skal forsigtig vendes op og ned for at blande opløsningen.
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 SAMT AFFALD HERAFS
English: Uncommon side effects (may affect up to 1 in 100 people): - eye discomfort - eye inflammation - eye irritation - eye redness - problems with the cornea - dilated pupil - blurred vision - reduction in sharpness of vision - small, dark shapes moving in the field of vision - itchy eyes - eyelid pain - sensation of foreign bodies in the eyes - glare - increased eye pressure
Danish: Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 personer): - øjenubehag - øjenbetændelse - øjenirritation - røde øjne - problemer med hornhinden - udvidede pupiller - sløret syn - nedsat synsskarphed - små mørke pletter, der bevæger sig i synsfeltet - kløende øjne - øjenlågssmerte - følelse af fremmedlegemer i øjet - blænding - forhøjet tryk i øjet
English: A single-dose toxicology study was conducted in African green monkeys exposed to ocular irrigation solutions containing the combination of phenylehphrine and ketorolac used during lens replacement surgery.
Danish: Der blev udført et enkeltdosis toksikologistudie i afrikanske grønne aber, der blev eksponeret for okulære skyllevæsker, der indeholdt den kombination af phenylephrin og ketorolac, der anvendes under linseudskiftningskirurgi.
English: Omidria is not indicated for undiluted use, intravitreal injection, general topical ophthalmic use, or non-ocular systemic use.
Danish: Omidria er ikke indiceret til ufortyndet brug, som intravitreal injektion, generel, lokal oftalmisk anvendelse eller ikke-okulær systemisk anvendelse.
English: This is known as intraocular lens replacement.
Danish: Dette indgreb kendes som intraokulær linseudskiftning.
English: Multipack containing 10 (1 pack of 10) single-use vials.
Danish: Multipakning med 10 (1 pakning med 10) hætteglas til engangsbrug.
English: Common side effects (may affect up to 1 in 10 people): - eye pain - inflammation of the front of the eye - red eyes - swelling of the cornea (the clear layer over the front of the eye) - sensitivity to light
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 personer): - øjensmerter - betændelse i den forreste del af øjet - røde øjne - hævelse af hornhinden (den gennemsigtige hinde, der dækker det forreste af øjet) - lysfølsomhed
English: METHOD OF ADMINISTRATION Intraocular use after dilution.
Danish: ADMINISTRATIONSMETODE Intraokulær anvendelse efter fortynding.