FrancophonIA/ELRC3.0 huggingface dataset:
English: DuoTrav can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
Danish: DuoTrav kan påvirke eller påvirkes af andre lægemidler, som du tager, herunder andre øjendråber til behandling af glaukom (grøn stær).
English: Each time you start a new bottle write down the date you open it in the spaces on the bottle label and carton.
Danish: Hver gang du starter med at bruge en ny flaske, skal du skrive datoen for åbning, hvor der er gjort plads til det på flaskens etiket og på kartonen.
English: The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.
Danish: Forekomsten af systemiske bivirkninger efter topikal oftalmologisk administration er lavere end efter systemisk administration.
English: Do not stop using DuoTrav without speaking to your doctor.
Danish: Du må ikke holde op med at bruge DuoTrav, uden at du har talt med din læge.
English: There are no or limited amount of data from the use of DuoTrav or the individual components in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af DuoTrav eller de enkelte aktive stoffer til gravide kvinder.
English: The adverse reactions listed in the table below were observed in clinical studies or with post-marketing experience.
Danish: Bivirkningerne i den nedenstående tabel, blev observeret i kliniske studier eller efter markedsføring.
English: Blood pressure diastolic decreased, blood pressure systolic increased
Danish: Nedsat diastolisk blodtryk, forhøjet systolisk blodtryk
English: Reproduction toxicity studies with travoprost have been undertaken in rats, mice and rabbits using the systemic route.
Danish: Reproduktions-toksicitetsstudier er blevet udført med travoprost på rotter, mus og kaniner, med systemisk indgivelse.
English: Tonography and fluorophotometry studies in man suggest that its predominant action is related to reduced aqueous humour formation and a slight increase in outflow facility.
Danish: Tonografi-og fluorofotometri-undersøgelser på mennesker tyder på, at dets dominerende virkning er relateret til reduceret dannelse af kammervæske og en let forøgelse af outflowet.
English: Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.
Danish: Patienter med alvorlige forstyrrelser/lidelser i det perifere kredsløb (f.eks. alvorlige former for Raynauds sygdom eller Raynauds syndrom) skal behandles med forsigtighed.
English: If you forget to use DuoTrav, continue with the next dose as planned.
Danish: Hvis du har glemt at bruge DuoTrav, skal du tage næste dosis som planlagt.
English: This pressure can lead to an illness called glaucoma.
Danish: Forhøjet tryk kan føre til en sygdom kaldet glaukom (grøn stær).
English: A statistically superior reduction in morning mean IOP (08:00, 24 hours after the last dose of DuoTrav) was observed compared to travoprost at all visits throughout the study.
Danish: En statistisk overlegen reduktion i gennemsnits-IOP om morgenen (08.00, 24 timer efter sidste dosis DuoTrav ) sås sammenlignet med travoprost ved alle besøg gennem hele studiet.
English: Metabolism: low blood sugar levels, increase in prostate cancer marker.
Danish: Stofskifte: Lavt blodsukkerniveau, forhøjet prostatacancer-markør.
English: Pack sizes of 1, 3 or 6 bottles.
Danish: Pakning indeholder 1, 3 eller 6 flasker.
English: A topical overdose with DuoTrav is not likely to occur or to be associated with toxicity.
Danish: En topikal overdosis af DuoTrav er usandsynlig og vil i givet fald sandsynligvis ikke være associeret med toksicitet.
English: Additional adverse reactions that have been seen with one of the active substances and may potentially occur with DuoTrav:
Danish: Øvrige bivirkninger, der er set ved indtagelse af et af de aktive stoffer, og som potentielt kan forekomme ved anvendelse af DuoTrav:
English: Uncommon Dyspnoea, postnasal drip Rare
Danish: Dyspnø, postnasal drip
English: Due to their negative effect on conduction time, beta blockers should only be given with caution to patients with first-degree heart block.
Danish: På grund af den negative effekt på overledningstiden bør betablokkere gives med forsigtighed til patienter med 1. grads hjerteblok.
English: Beta blockers may increase the hypoglycaemic effect of antidiabetic medicinal products.
Danish: Betablokkere kan øge den hypoglykæmiske virkning af antidiabetika.
English: Travoprost is a prodrug that undergoes rapid ester hydrolysis in the cornea to the active free acid.
Danish: Travoprost er et prodrug, der gennemgår en hurtig esterhydrolyse i cornea til den aktive frie syre.
English: The effect on intra-ocular pressure or the known effects of systemic beta blockade may be potentiated when timolol is given to patients already receiving a systemic beta-blocking medicinal product.
Danish: Virkningen på det intraokulære tryk eller de kendte virkninger af systemisk betablokade kan potenseres, når timolol gives til patienter, der allerede får en systemisk betablokker.
English: • After using DuoTrav, press your finger into the corner of your eye by your nose for 2 minutes
Danish: • Efter at have dryppet med DuoTrav, skal du trykke din finger mod øjenkrogen ind mod næsen i
English: Timolol should not be used during pregnancy unless clearly necessary.
Danish: Timolol bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
English: However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta blockade in the infant.
Danish: Ved terapeutiske doser af timolol i øjendråber er det dog ikke sandsynligt, at mængden i mælken er tilstrækkelig til at give kliniske symptomer på betablokade hos spædbørn.
English: It should be administered at the same time each day.
Danish: DuoTrav bør indgives på samme tidspunkt hver dag.
English: Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicines including quinidine (used to treat heart conditions and some types of malaria), medicines to treat diabetes or the antidepressants fluoxetine or paroxetine.
Danish: Fortæl din læge, hvis du bruger eller overvejer at bruge lægemidler til sænkning af blodtrykket, hjertemedicin, herunder quinidin (der bruges til behandling af hjertelidelser og visse typer malaria), lægemidler til behandling af sukkersyge (diabetes) eller midler mod depression, der indeholder fluoxetin og paroxetin.
English: Non-clinical data revealed no special hazard for humans with timolol based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Danish: Prækliniske data for timolol viste ingen speciel risiko for mennesker ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: As with any eye drops, temporary blurred vision or other visual disturbances may occur.
Danish: Det gælder for alle øjendråber, at der kan forekomme sløret syn eller andre synsforstyrrelser.
English: DuoTrav may get into your milk.
Danish: DuoTrav kan gå over i mælken.
English: • Do not touch your eye or eyelid, the surrounding areas or other surfaces with the dropper.
Danish: • Undgå at berøre øjet eller øjenlåget, de omgivende områder eller andre overflader med spidsen af flasken.
English: Only use DuoTrav as eye drops.
Danish: DuoTrav må kun bruges som øjendråber.
English: Animal studies showed no effect of travoprost on fertility at doses up to 75 times the maximum recommended human ocular dose, whereas no relevant effect of timolol was noted at this dose level.
Danish: Dyrestudier har vist, at travoprost ikke har nogen effekt på fertiliteten ved doser på op til 75 gange den anbefalede maksimale, humane, okulære dosis, mens ingen relevant virkning af timolol bemærkedes ved denne dosiseksponering.
English: Only use DuoTrav in both eyes if your doctor told you to do so.
Danish: Brug kun DuoTrav i begge øjne, hvis din læge har ordineret det.
English: In clinical studies involving 2,170 patients treated with DuoTrav the most frequently reported treatment-related adverse reaction was ocular hyperaemia (12.0%).
Danish: I kliniske studier, der omfattede 2.170 patienter, som blev behandlet med DuoTrav, var den hyppigst rapporterede behandlingsrelaterede bivirkning okulær hyperæmi (12,0%).
English: Use DuoTrav for as long as your doctor has told you to.
Danish: Brug DuoTrav så længe, som din læge har ordineret det.
English: Reproduction toxicity studies with timolol showed delayed foetal ossification in rats with no adverse effects on postnatal development (7000 times the clinical dose) and increased foetal resorptions in rabbits (14000 times the clinical dose).
Danish: Reproduktionstoksicitetsstudier med timolol viste forsinket føtal ossifikation hos rotter uden nogen bivirkninger på den postnatale udvikling (7.000 gange den kliniske dosis) og øgede føtale resorptioner hos kaniner (14.000 gange den kliniske dosis).
English: The non-inferiority of DuoTrav as compared to latanoprost 50 micrograms/mL + timolol 5 mg/mL in the mean IOP reduction was demonstrated across all time-points at all visits.
Danish: Non-inferiority for DuoTrav sammenlignet med latanoprost 50 mikrogram/ml + timolol 5 mg/ml i den gennemsnitlige IOP-reduktion blev påvist på tværs af alle tidspunkter ved alle besøg.
English: The mechanism of eyelash changes and their long-term consequences are currently unknown.
Danish: Mekanismen bag øjenvippe-forandringerne og deres langtidskonsekvenser er endnu ukendt.
English: Reproduction and development studies have demonstrated a potent effect on foetal loss with a high rate observed in rats and mice (180 pg/mL and 30 pg/mL plasma, respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/mL).
Danish: Reproduktions-og udviklingsstudier har vist en potent effekt på føtalt tab med en høj frekvens hos rotter og mus (henholdsvis 180 pg/ml og 30 pg/ml plasma) ved eksponering 1,2 til 6 gange den kliniske eksponering (op til 25 pg/ml).
English: If you are using other eye drops in addition to DuoTrav, leave at least 5 minutes between applying DuoTrav and the other drops.
Danish: Hvis du bruger andre øjenlægemidler udover DuoTrav, så vent mindst 5 minutter mellem at du bruger DuoTrav og de andre øjenlægemidler.
English: • eye inflammation.
Danish: • betændelse i øjet.
English: Sexual dysfunction, decreased libido
Danish: Seksuel dysfunktion, nedsat libido
English: In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension, therapy with beta blockers should be critically assessed and therapy with other active substances should be considered.
Danish: Hos patienter med hjertekarsygdomme (f.eks. koronarsklerose, Prinzmetal angina og hjerteinsufficiens) og hypotension bør behandling med betablokkere vurderes omhyggeligt, og behandling med andre aktive stoffer bør overvejes.
English: Not known (frequency cannot be estimated from the available data) Effects in the eye
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data)
English: Pharmacotherapeutic group: Ophthalmologicals; Antiglaucoma preparations and miotics, ATC code: S01ED51.
Danish: Farmakoterapeutisk klassifikation: Oftalmologiske midler, Antiglaukom-præparater og miotika, ATC-kode: S01ED51
English: Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second- or third-degree atrioventricular block not controlled with pacemaker.
Danish: Sinusbradykardi, syg sinus-syndrom, herunder sino-atrialt blok, 2. eller 3. grads AV-blok, der ikke kontrolleres med pacemaker.
English: Severe allergic rhinitis and corneal dystrophies.
Danish: Alvorlig allergisk rinit og corneadystrofier.
English: The side effects listed below include reactions seen with the class of beta blockers used for treating eye conditions or reactions seen with travoprost alone:
Danish: Nedenstående bivirkninger dækker reaktioner, der er set med andre betablokkere brugt til behandling af øjenlidelser, eller reaktioner set med travoprost alene:
English: The plasma t1/2 of timolol is 4 hours after ocular administration of DuoTrav.
Danish: Plasma t1/2 for timolol er 4 timer efter okulær indgivelse af DuoTrav.
English: Travoprost has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey.
Danish: Det er påvist, at travoprost har forårsaget let forstørrelse af den palpebrale fissur ved undersøgelser af aber.
English: Overt cardiac failure, cardiogenic shock.
Danish: Åbenlys hjerteinsufficiens, kardiogent shock.
English: Respiratory disorders
Danish: Respirationsfortyrrelser
English: Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of topical ocular administration (1.4 micrograms once daily).
Danish: Travopost øgede signifikant blodgennemstrømningen gennem synsnerven hos kaniner efter 7 dages topikal okulær indgivelse (1,4 mikrogram, en gang dagligt).
English: Hypersensitivity to other beta blockers.
Danish: Overfølsomhed over for andre betablokkere.
English: Sodium hydroxide and/ or hydrochloric acid (for pH adjustment) Purified water
Danish: Natriumhydroxid og saltsyre (til at justere pH) Renset vand
English: Travoprost free acid can be measured in the aqueous humour during the first few hours in animals and in human plasma only during the first hour after ocular administration of DuoTrav.
Danish: Den frie syre af travoprost kan måles i kammervæsken i de første få timer hos dyr og i human plasma blot i den første time efter okulær indgivelse af DuoTrav.
English: Tiny amounts of sodium hydroxide or hydrochloric acid are added to keep acidity levels (pH levels) normal.
Danish: Små mængder natriumhydroxid eller saltsyre er tilsat for at holde surhedsgraden (pH-niveauet) normal.
English: Women of childbearing potential/contraception
Danish: Kvinder i den fertile alder/prævention
English: Epidemiological studies have not revealed malformative effects but show a risk for intrauterine growth retardation when beta blockers are administered by the oral route.
Danish: Epidemiologiske studier har ikke vist forekomst af misdannelser, men der er påvist en risiko for intrauterin væksthæmning ved oral administration af betablokkere.
English: • if you have a slow heartbeat, heart failure or a disorder of heart rhythm (irregular heartbeat).
Danish: • hvis du har en langsom puls, hjertesvigt eller forstyrrelser i hjerterytmen (uregelmæssig puls).
English: The recommended dose is one drop in the affected eye or eyes once a day in the morning or in the evening.
Danish: Den anbefalede dosis er én dråbe i det/de pågældende øje/øjne, én gang dagligt - om morgenen eller om aftenen.
English: Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 mL/min).
Danish: Travoprost er blevet undersøgt hos patienter med let til svær leverinsufficiens og hos patienter med let til svær nyreinsufficiens (kreatinin-clearance så lav som 14 ml/min).
English: Findings are related to FP receptor agonist activity in uterus with early embryolethality, post-implantation loss and foetotoxicity.
Danish: Fund er relateret til FP receptoragonist-aktivitet i uterus med tidlig embryonal letalitet (fosterdød), post-implantation tab og føtal-toksicitet (fostertoksicitet).
English: • If you have to use DuoTrav in both eyes, repeat the above steps for your other eye.
Danish: • Hvis du skal dryppe begge øjne, så gentag processen i det andet øje.
English: Macular oedema has been reported during treatment with prostaglandin F2 analogues.
Danish: Der er rapporteret makulaødem under behandling med prostaglandin F2-analoger.
English: In pregnant rats, systemic administration of travoprost at doses more than 200 times the clinical dose during the period of organogenesis resulted in an increased incidence of malformations.
Danish: Hos drægtige rotter resulterede systemisk indgivelse af travoprost i doser på mere end 200 gange den kliniske dosis gennem organogenese-perioden i et forøget antal misdannelser.
English: While taking beta blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
Danish: Under behandling med betablokkere kan patienter med en anamnese med atopi eller svære anafylaktiske reaktioner over for en række allergener være mere reaktive over for gentagen udsættelse for sådanne allergener og risikere ikke at respondere på normale doser af adrenalin til behandling af anafylaktiske reaktioner.
English: • myasthenia gravis (chronic neuromuscular weakness).
Danish: • myasthenia gravis (kronisk sygdom med abnorm muskeltræthed).
English: Following once-daily administration of DuoTrav PQ in healthy subjects (N=22) for 5 days, travoprost free acid was not quantifiable in plasma samples from the majority of subjects (94.4%) and generally was not detectable one hour after dosing.
Danish: Efter dosering en gang dagligt af DuoTrav PQ hos raske forsøgspersoner (N=22) i 5 dage kunne den frie syre af travoprost ikke kvantificeres i plasmaprøver fra hovedparten af forsøgspersonerne (94,4%) og var generelt ikke sporbar 1 time efter doseringen.
English: The mean timolol steady-state Cmax was 1.34 ng/ml and Tmax was approximately 0.69 hours after once-daily administration of DuoTrav.
Danish: Den gennemsnitlige steady-state for timolol Cmax var 1,34 ng/ml, og Tmax var cirka 0,69 time efter en daglig dosering af DuoTrav.
English: The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta blockers.
Danish: Den hypertensive reaktion på pludselig seponering af clonidin kan potenseres af betablokkere.
English: DuoTrav should be used with caution in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.
Danish: DuoTrav bør anvendes med forsigtighed hos patienter med let/moderat KOL, og kun hvis den potentielle fordel opvejer den potentielle risiko.
English: Corneal diseases
Danish: Sygdomme i cornea
English: It is therefore important to tell the doctor that you are using DuoTrav when you are to receive any other treatment.
Danish: Husk derfor at fortælle din læge, at du får DuoTrav, hvis du skal til at have en anden behandling.
English: Like other medicines administered to the eyes, travoprost and timolol (a beta blocker) are absorbed into the blood.
Danish: Ligesom andre lægemidler, der anvendes i øjnene, absorberes travoprost og timolol (en betablokker) i blodet.
English: What DuoTrav contains
Danish: DuoTrav indeholder:
English: If DuoTrav is administered until delivery, the neonate should be carefully monitored during the first days of life.
Danish: Hvis DuoTrav anvendes frem til fødslen, skal det nyfødte barn overvåges nøje de første døgn efter fødslen.
English: No studies have been conducted with DuoTrav or with timolol 5 mg/mL eye drops in patients with hepatic or renal impairment.
Danish: Der er ikke udført studier med DuoTrav eller timolol 5 mg/ml øjendråber hos patienter med nedsat lever- eller nyrefunktion.
English: Polyoxyethylene hydrogenated castor oil 40 (HCO-40) Boric acid
Danish: Polyoxyleret, hydrogeneret ricinusolie 40 (HCO-40) Borsyre
English: Respiratory reactions, including death due to bronchospasm in patients with asthma, have been reported following administration of some ophthalmic beta blockers.
Danish: Luftvejsreaktioner, herunder dødsfald som følge af bronkospasme hos patienter med astma, er indberettet efter administration af oftalmologiske betablokkere.
English: Ask your pharmacist how to throw away medicines you longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: 2.5 mL oval polypropylene (PP) or low-density polyethylene (LDPE) bottle and PP or LDPE dispensing plug with PP screw cap, presented in an overwrap.
Danish: 2,5 ml oval flaske af polypropylen (PP) eller af polyethylen med lav densitet (LDPE) og med dråbespids af PP eller LDPE med et skruelåg af PP indpakket i beskyttelsesfolie.
English: Packs of 1, 3 or 6 bottles.
Danish: Pakninger med 1, 3 eller 6 plastflasker.
English: The incidence of side effects after administration to the eyes is lower than after administration by mouth or by injection.
Danish: Forekomsten af bivirkninger efter indgivelse i øjnene er lavere end efter indgivelse gennem munden, eller når det indsprøjtes.
English: DuoTrav should not be used during pregnancy unless clearly necessary.
Danish: DuoTrav bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: When substituting another ophthalmic antiglaucoma medicinal product with DuoTrav, the other medicinal product should be discontinued and DuoTrav should be started the following day.
Danish: Hvis DuoTrav erstatter anden oftalmologisk behandling mod glaukom, seponeres denne, og behandling med DuoTrav påbegyndes den efterfølgende dag.
English: Mean IOP reductions were non-inferior, although numerically lower, to those achieved by concomitant therapy with travoprost 40 micrograms/mL dosed once daily in the evening and timolol 5 mg/mL dosed once daily in the morning.
Danish: Gennemsnitlige IOP-reduktioner var non-inferior, selv om de var numerisk lavere, end dem, der blev opnået ved samtidig behandling med travoprost 40 mikrogram/ml doseret en gang dagligt om aftenen og timolol 5 mg/ml doseret en gang dagligt om morgenen.
English: For information on how to reduce systemic absorption, see section 4.2.
Danish: For information om hvordan systemisk absorption reduceres, se pkt.
English: DuoTrav may increase the length, thickness, colour and/or number of your eyelashes and may cause unusual hair growth on your eyelids.
Danish: DuoTrav kan give længere eller tykkere øjenvipper, ændre farven og/eller antal hår i dine øjenvipper samt medføre usædvanlig hårvækst på dine øjenlåg.
English: • disturbances of heart rate such as slow heartbeat.
Danish: • forstyrrelser i hjerterytmen, som fx langsom puls.
English: Timolol is a beta blocker which works by reducing the production of fluid within the eye.
Danish: Timolol er en betablokker, som virker ved at nedsætte væskeproduktionen i øjet.
English: Travoprost is a prostaglandin analogue which works by increasing the outflow of aqueous fluid from the eye, which lowers its pressure.
Danish: Travoprost er en prostaglandin-analog, som virker ved at øge væskeafløbet fra øjet, hvilket sænker trykket i øjet.
English: DuoTrav must not be used in women of child-bearing age/potential unless adequate contraceptive measures are in place (see section 5.3).
Danish: DuoTrav må ikke anvendes til kvinder i den fertile alder, medmindre der anvendes tilstrækkelig prævention (se pkt.
English: If you forget to use DuoTrav
Danish: Hvis du har glemt at bruge DuoTrav
English: Do not open the overwrap until you need to use the bottle.
Danish: Bryd ikke beskyttelsesfolien på en ny flaske, før du har brug for det.
English: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects, e.g. of adrenaline.
Danish: Oftalmologiske betablokkere kan blokere effekten af systemiske beta-agonister, f.eks. adrenalin.
English: Do not use DuoTrav
Danish: Brug ikke DuoTrav
English: There is no experience of DuoTrav in inflammatory ocular conditions, nor in neovascular, angle-closure, narrow-angle or congenital glaucoma, and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.
Danish: Der foreligger ingen erfaring med DuoTrav ved inflammatoriske øjenlidelser eller ved neovaskulær lukketvinklet, snævervinklet eller kongenit glaukom, og kun begrænset erfaring med skjoldbruskkirtel-induceret øjensygdom, ved åben-vinkel glaukom hos pseudofake-patienter og ved pigmentdannende eller pseudoeksfoliativt glaukom.