FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of an overdose would include supportive and symptomatic therapy.
Danish: Behandling af en overdosis bør omfatte understøttende og symptomatisk behandling.
English: If the pressure in the eye is too high, it can damage your sight.
Danish: Hvis trykket i øjet er for stort, kan det skade synet.
English: Studies in animal and man suggest that the main mechanism of action is increased trabecular outflow.
Danish: Studier hos dyr og mennesker tyder på, at den primære virkningsmekanisme er øget trabekulært afløb.
English: Do not drive or use machines until the symptoms are cleared.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, før symptomerne er forsvundet.
English: The safety of netarsudil has been evaluated in clinical studies, including four well-controlled Phase 3 studies.
Danish: Sikkerheden ved netarsudil er undersøgt i kliniske studier, herunder fire velkontrollerede fase 3studier.
English: Each bottle contains 2.5 ml of the medicine and each pack contains one bottle with a screw-cap.
Danish: Hver flaske indeholder 2,5 ml lægemiddel, og hver pakning indeholder én flaske med et skruelåg.
English: • Do not touch the dropper with your fingers when opening or closing the bottle.
Danish: • Rør ikke dråbespidsen med fingrene, når du åbner eller lukker flasken.
English: It is unknown whether netarsudil/metabolites are excreted in human milk.
Danish: Det er ukendt, om netarsudil/metabolitter udskilles i human mælk.
English: Long-term studies in animals have not been performed to evaluate the carcinogenic potential of netarsudil.
Danish: Der er ikke gennemført længerevarende studier hos dyr for at evaluere netarsudils karcinogene potentiale.
English: Clear solution, pH 5 (approximately).
Danish: Klar opløsning, pH 5 (ca.).
English: Day 15
Danish: Dag 15
English: Approximately 75% of subjects included in the netarsudil treatment groups of Phase 3 studies were Caucasian and 24% Black or African American.
Danish: Ca. 75 % af forsøgspersonerne i de grupper, der blev behandlet med netarsudil i fase 3-studierne, var kaukasiere, og 24 % var sorte eller afroamerikanere.
English: Rhokiinsa should not be used in children and teenagers under 18 years of age as it has only been studied in adults.
Danish: Rhokiinsa bør ikke bruges til børn og unge under 18 år, da det kun er undersøgt hos voksne.
English: Cornea verticillata occurred in approximately 20% of the patients in controlled Phase 3 clinical studies.
Danish: Cornea verticillata sås hos ca. 20 % af patienterne i kontrollerede kliniske fase 3-studier.
English: Do not stop using Rhokiinsa without first speaking to your doctor.
Danish: Hold ikke op med at bruge Rhokiinsa uden at tale med lægen først.
English: Do not use Rhokiinsa if you are pregnant unless your doctor still recommends it.
Danish: Brug ikke Rhokiinsa, hvis du er gravid, medmindre lægen stadig anbefaler det.
English: The following side effects have been observed with Rhokiinsa:
Danish: Følgende bivirkninger er blevet rapporteret ved brug af Rhokiinsa:
English: Over half were aged ≥ 65 years.
Danish: Mere end halvdelen var 65 år eller derover.
English: Eye ointments should be administered last.
Danish: Øjensalve bør administreres sidst.
English: • General side effects: Headache
Danish: • Andre bivirkninger: Hovedpine
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: The drop will go in here (Picture 1).
Danish: Det er her, dråben skal dryppes i (figur 1).
English: If you stop using Rhokiinsa the pressure in your eye will not be controlled which could lead to loss of sight.
Danish: Hvis du holder op med at bruge Rhokiinsa, vil trykket i dit øje ikke være kontrolleret, og det kan medføre synstab.
English: • Gently squeeze the bottle to release one drop of Rhokiinsa into your eye.
Danish: • Klem forsigtigt om flasken for at frigive én dråbe Rhokiinsa i øjet.
English: The primary efficacy outcome measure was mean IOP at each of 9 timepoints measured at 08:00, 10:00 and 16:00 on day 15, day 43 and day 90.
Danish: Det primære effektmål var det gennemsnitlige intraokulære tryk på 9 forskellige tidspunkter, nemlig kl. 8.00, 10.00 og 16.00 på dag 15, dag 43 og dag 90.
English: Day 43
Danish: Dag 43
English: Day 90
Danish: Dag 90
English: There are no or limited amount of data from the use of netarsudil in pregnant women.
Danish: Der foreligger ingen eller kun begrænsede oplysninger om anvendelse af netarsudil hos gravide kvinder.
English: The safety and efficacy of Rhokiinsa in children below the age of 18 years have not been established.
Danish: Rhokiinsas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: INFORMATION IN BRAILLE Rhokiinsa
Danish: INFORMATION I BRAILLESKRIFT Rhokiinsa
English: Only use Rhokiinsa for your eyes (ocular use).
Danish: Brug kun Rhokiinsa til øjnene (okulær anvendelse).
English: Subjects with known contraindications or hypersensitivity to timolol were excluded from the studies.
Danish: Forsøgspersoner med kendte kontraindikationer eller overfølsomhed over for timolol blev udelukket fra studierne.
English: Rhokiinsa has negligible influence on the ability to drive and use machines.
Danish: Rhokiinsa påvirker kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: However, there was a relatively small proportion of subjects with moderate or severe hyperaemia who discontinued treatment because of this adverse reaction (6.0% in Phase 3 clinical studies).
Danish: Der var dog en relativt lille andel forsøgspersoner med moderat til svær hyperæmi, som ophørte med behandlingen på grund af denne bivirkning (6,0 % i de kliniske fase 3-studier).
English: There are no data on the effects of netarsudil on male or female fertility.
Danish: Der foreligger ingen data om netarsudils indvirkning på mandlig og kvindelig fertilitet.
English: Twice a day dosing was also associated with a higher discontinuation rate due to adverse reactions (53.8%) during a 12-month study.
Danish: Dosering to gange om dagen var også forbundet med en højere seponeringsrate som følge af bivirkninger (53,8 %) i et 12-måneders studie.
English: You may find that your vision is blurred or abnormal just after using Rhokiinsa.
Danish: Dit syn kan blive sløret eller unormalt umiddelbart efter anvendelse af Rhokiinsa.
English: The majority of cornea verticillata resolved upon discontinuation of treatment.
Danish: Størstedelen af tilfældene af cornea verticillata forsvandt ved seponering af behandlingen.
English: Store in a refrigerator (2°C - 8°C) until opened.
Danish: Opbevares i køleskab (2-8 °C) indtil åbning.
English: Rhokiinsa should not be used during pregnancy unless the clinical condition of the woman requires treatment with netarsudil.
Danish: Rhokiinsa bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver anvendelse af netarsudil.
English: Unopened bottles: Store in a refrigerator (2°C - 8°C).
Danish: Uåbnede flasker: Opbevares i køleskab (2-8 °C).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to development.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogent potentiale og udviklingstoksicitet.
English: Reactions are classified according to the 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) or not known (cannot be estimated from the available data).
Danish: ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If netarsudil is to be used concomitantly with other topical ophthalmic medicinal products, each medicinal product should be administered at least five (5) minutes apart.
Danish: Hvis netarsudil skal anvendes samtidigt med andre topiske oftalmologiske lægemidler, bør de enkelte lægemidler administreres med mindst 5 minutters mellemrum.
English: Intravenous administration of netarsudil mesylate to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures.
Danish: Intravenøs administration af netarsudilmesylat hos drægtige rotter og kaniner under organogenesen medførte ikke negative embryoføtale virkninger ved klinisk relevante systemiske eksponeringer.
English: Due to netarsudil's vasodilating properties, other eye drops should be administered before.
Danish: På grund af netarsudils vasodilaterende egenskaber bør andre øjendråber administreres først.
English: • Do not touch your eye, eyelid, surrounding areas or other surfaces with the dropper.
Danish: • Undgå at berøre øjet eller øjenlåget, omkringliggende områder eller andre overflader med dråbespidsen.
English: It is therefore recommended to dose netarsudil once daily.
Danish: Derfor anbefales dosering af netarsudil én gang dagligt.
English: The incidence of cornea verticillata was higher in certain subpopulations: elderly (≥65 years) versus non-elderly (24.8 vs. 15.9%); males versus females (24.4 vs. 18.4%) and in white versus other races (25.6 vs. 7.0%).
Danish: Forekomsten af cornea verticillata var højere hos visse delpopulationer: ældre (≥ 65 år) vs. ikke-ældre (24,8 vs. 15,9 %), mænd vs. kvinder (24,4 vs. 18,4 %) og hvide vs. andre etniske grupper (25,6 vs. 7,0 %).
English: Opened bottle: 4 weeks after first opening the bottle.
Danish: Åbnet flaske: 4 uger efter anbrud af flasken.
English: Pharmacotherapeutic group: Ophthalmologicals, antiglaucoma preparations and miotics, ATC code: S01EX05
Danish: Farmakoterapeutisk klassifikation: Oftalmologica, antiglaucom-midler og miotica, ATC-kode: S01EX05
English: If you are using other eye drops, wait at least five minutes after using them and then use Rhokiinsa.
Danish: Hvis du også bruger andre øjendråber, skal du vente mindst 5 minutter efter drypning med dem, før du drypper med Rhokiinsa.
English: Animal studies with intravenous administration do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3).
Danish: Dyreforsøg med intravenøs administration indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet, ved klinisk relevante eksponeringer (se pkt.
English: Marketing Authorisation Holder and Manufacturer Aerie Pharmaceuticals Ireland, Limited Athlone Business and Technology Park, Dublin Road,
Danish: Indehaver af markedsføringstilladelsen og fremstiller Aerie Pharmaceuticals Ireland, Limited Athlone Business and Technology Park, Dublin Road,
English: If you are using eye ointments, these should be used last.
Danish: Hvis du bruger øjensalve, bør salven påføres sidst.
English: The most common ocular adverse reaction observed is conjunctival hyperemia which was reported in 51% of patients.
Danish: Den hyppigst observerede okulære bivirkning er konjunktival hyperæmi, der er rapporteret hos 51 % af patienterne.
English: What you need to know before you use Rhokiinsa Do not use Rhokiinsa: - if you are allergic to netarsudil or any of the other ingredients of this medicine (listed in section
Danish: Det skal du vide, før du begynder at bruge Rhokiinsa Brug ikke Rhokiinsa: - hvis du er allergisk over for netarsudil eller et af de øvrige indholdsstoffer i dette lægemiddel
English: The non-inferiority margin applied was a difference in mean IOP ≤1.5 mmHg for all time points over all visits through 3 months and ≤1.0 mmHg at a majority of these time points.
Danish: Den anvendte margen for non-inferioritet var en forskel i gennemsnitligt intraokulært tryk på ≤ 1,5 mmHg for alle tidspunkter og alle besøg til og med måned 3 og ≤ 1,0 mmHg ved de fleste af disse tidspunkter.
English: Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Danish: Benzalkoniumchlorid kan absorberes af bløde kontaktlinser og kan ændre farven på kontaktlinserne.
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 æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/ml) post dose on day 1 and day 8.
Danish: Der var ingen kvantificerbare plasmakoncentrationer af netarsudil (nedre kvantificeringsgrænse (LLOQ) på 0,100 ng/ml) efter administration på dag 1 og dag 8.
English: This medicinal product contains benzalkonium chloride.
Danish: Dette lægemiddel indeholder benzalkoniumchlorid.
English: Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye).
Danish: Benzalkoniumchlorid kan også forårsage øjenirritation, især hvis du har tørre øjne eller problemer med hornhinden (den klare hinde forrest på øjet).
English: After opening the bottle: Do not store above 25°C.
Danish: Efter åbning af flasken: Må ikke opbevares ved temperaturer over 25 °C.
English: Other medicines and Rhokiinsa Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Rhokiinsa Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: With the exception of cornea verticillata (see above), no difference in the safety profile for Rhokiinsa has been observed between subjects aged <65 or ≥65 years.
Danish: Med undtagelse af cornea verticillata (se ovenfor) er der ikke set nogen forskel i sikkerhedsprofilen for Rhokiinsa mellem forsøgspersoner under 65 år og forsøgspersoner på 65 år eller derover.
English: Rhokiinsa is supplied sterile in opaque white low density polyethylene bottles (2.5 ml fill in a 4 ml container) and tips with white polypropylene caps and anti-tamper seals.
Danish: Rhokiinsa leveres sterilt i uigennemsigtige hvide flasker af lavdensitetspolyethylen (2,5 ml fyldt i en 4 ml-beholder) med spids og hvide polypropylenlåg og sikkerhedsforsegling.
English: • Pull down your lower eyelid with a clean finger to form a ‘pocket' between the eyelid and your eye.
Danish: • Træk det nedre øjenlåg nedad med en ren finger, så der dannes en sprække mellem øjenlåget og øjet.
English: The efficacy and safety of netarsudil in subjects with compromised corneal epithelium or co-existing ocular pathologies e.g. pseudoexfoliation and dispersion pigment syndrome has not been established.
Danish: Netarsudils virkning og sikkerhed hos patienter med kompromitteret hornhindeepitel eller samtidige andre okulære sygdomme, f.eks. pseudoeksfoliering og pigmentdispersionsyndrom, er ikke fastlagt.
English: • Only put one drop into your eye each time.
Danish: • Dryp kun én dråbe i øjet ved hver drypning.
English: Timolol 0.5% twice daily Difference (95% CI) Netarsudil - Timolol
Danish: Forskel (95 %-KI) Netarsudil - timolol
English: If a drop misses your eye, try again.
Danish: Hvis dråben ikke rammer øjet, så dryp igen.
English: After topical ocular dosing, netarsudil is metabolised by esterases in the eye to an active metabolite, AR-13503.
Danish: Efter topisk okulær administration metaboliseres netarsudil af esteraser i øjet til en aktiv metabolit (AR-13503).
English: Benzalkonium chloride, boric acid, mannitol, sodium hydroxide, water for injections.
Danish: Benzalkoniumchlorid, borsyre, mannitol, natriumhydroxid, vand til injektionsvæsker.
English: Systemic exposure to netarsudil following topical ocular administration has been shown to be negligible.
Danish: Den systemiske eksponering for netarsudil efter topisk okulær administration er vist at være ubetydelig.
English: Rhokiinsa contains benzalkonium chloride This medicine contains approximately 150 micrograms benzalkonium chloride in each ml of solution.
Danish: Rhokiinsa indeholder benzalkoniumchlorid Dette lægemiddel indeholder ca. 150 mikrogram benzalkoniumchlorid i hver ml opløsning.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I non-kliniske studier blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i tilstrækkelig grad.
English: These studies also suggest that netarsudil lowers IOP by reducing episcleral venous pressure.
Danish: Disse studier tyder også på, at netarsudil sænker det intraokulære tryk ved at reducere det episklerale venetryk.
English: Conjunctival Hyperaemia
Danish: Konjunktival hyperæmi
English: Treatment with Rhokiinsa should only be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Danish: Behandling med Rhokiinsa bør kun iværksættes af en oftalmolog eller en sundhedsperson med erfaring inden for oftalmologi.
English: Conjunctival hyperaemia was typically mild in severity and sporadic.
Danish: Konjunktival hyperæmi var typisk af sværhedsgraden let samt sporadisk.
English: If transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.
Danish: Hvis der opstår forbigående sløret syn ved drypning, bør patienten vente med at føre motorkøretøj eller betjene maskiner, til synet er klart igen.
English: decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Rhokiinsa therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Rhokiinsa seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The majority of discontinuations in the netarsudil group were associated with ocular adverse reactions, whereas the majority of discontinuations in the timolol group were associated with non-ocular adverse reactions.
Danish: Størstedelen af seponeringerne i netarsudil-grupperne var relateret til okulære bivirkninger, mens størstedelen af seponeringerne i timolol-grupperne var relateret til ikke-okulære bivirkninger.
English: Uncommon hypersensitivity
Danish: Ikke almindelig overfølsomhed
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rhokiinsa in all subsets of the paediatric population for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Rhokiinsa i alle undergrupper af den pædiatriske population med hensyn til reduktion af forhøjet intraokulært tryk hos patienter med åbenvinklet glaukom eller okulær hypertension.
English: No data on potential interactions specific to netarsudil is currently available (see section 4.5).
Danish: Der foreligger aktuelt ingen data om mulige interaktioner specifikt for netarsudil (se pkt.
English: The most frequently reported adverse reactions associated with discontinuation in the Rhokiinsa groups were conjunctival hyperemia (5.8%), cornea verticillata (3.7%) and vision blurred (1.4%).
Danish: De hyppigste bivirkninger, der medførte seponering i Rhokiinsa-grupperne, var konjunktival hyperæmi (5,8 %), cornea verticillata (3,7 %) og sløret syn (1,4 %).
English: With the exception of the incidence of cornea verticillata, no other difference in safety profile was observed between races or age groups (see section 4.8).
Danish: Bortset fra forekomsten af cornea verticillata blev der ikke observeret nogen forskel i sikkerhedsprofilen mellem de etniske grupper og mellem aldersgrupperne (se pkt.
English: The systemic exposures of netarsudil and its active metabolite, AR-13503, were evaluated in 18 healthy subjects after topical ocular administration of netarsudil once daily (one drop bilaterally in the morning) for 8 days.
Danish: Den systemiske eksponering for netarsudil og dets aktive metabolit, AR-13503, blev undersøgt hos 18 raske voksne forsøgspersoner efter topisk okulær administration af netarsudil én gang dagligt (én dråbe i begge øjne om morgenen) i 8 dage.
English: • Put back the bottle cap to close the bottle.
Danish: • Skru låget på flasken igen for at lukke den.
English: Conjunctival hyperaemia was the most frequently reported adverse reaction associated with netarsudil treatment in clinical trials and it is attributed to the vasodilation effect of the Rho kinase inhibitor drug class.
Danish: Konjunktival hyperæmi var den hyppigst rapporterede bivirkning forbundet med netarsudil-behandling i kliniske studier, og det skyldes den vasodilaterende effekt ved klassen af Rho-kinase-hæmmere.
English: • Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Danish: Gør det foran et spejl, hvis det hjælper.
English: It should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Danish: Det bør anvendes med forsigtighed hos patienter, der har tørre øjne, og patienter med sarte hornhinder.
English: Only one plasma concentration at 0.11 ng/ml for the active metabolite was observed for one subject on day 8 at 8 hours post-dose.
Danish: Der blev kun observeret én plasmakoncentration på 0,11 ng/ml af den aktive metabolit hos én forsøgsperson på dag 8 otte timer efter administration.
English: Netarsudil was not mutagenic in a bacterial mutation assay, in a mouse lymphoma assay, or in a rat micronucleus test.
Danish: Netarsudil var ikke mutagent i et studie af bakteriemutationer, i en lymfomtest hos mus og i en mikronukleustest hos rotter.
English: Instillation site erythema (8%), corneal staining (7%), blurred vision (6%), increased lacrimation (6%) and erythema of eyelid (5%) were also reported.
Danish: Der er også rapporteret om erytem ved instillationsstedet (8 %), farvning af hornhinden (7 %), sløret syn (6 %), øget tåredannelse (6 %) og erytem i øjenlåget (5 %).
English: Contact lenses should be removed prior to instillation of netarsudil and may be reinserted 15 minutes following its administration (see section 4.4).
Danish: Kontaktlinser bør fjernes før drypning med netarsudil og kan sættes i igen 15 minutter efter drypningen (se pkt.
English: Warnings and precautions • Do not use Rhokiinsa more than once a day, as you may experience more side effects.
Danish: • Brug kun Rhokiinsa én gang om dagen, da du ellers kan opleve flere bivirkninger.
English: The recommended dose is one drop in the affected eye or eyes once a day in the evening.
Danish: Den anbefalede dosis er én dråbe i det eller de berørte øjne én gang dagligt om aftenen.
English: Rhokiinsa contains an active substance called netarsudil.
Danish: Rhokiinsa indeholder det aktive stof netarsudil.
English: Sodium hydroxide (for pH-adjustment) Water for injections
Danish: Natriumhydroxid (til pH-justering)
English: Patients should not instill more than one drop in the affected eye(s) each day.
Danish: Patienterne bør ikke dryppe mere end 1 dråbe i det eller de berørte øjne dagligt.