FrancophonIA/ELRC3.0 huggingface dataset:
English: It is a synthetic prostamide, structurally related to prostaglandin F2 (PGF2), that does not act through any known prostaglandin receptors.
Danish: Det er et syntetisk prostamid, som i strukturen ligner prostaglandin F2 (PGF2), og som ikke virker gennem nogen kendte prostaglandinreceptorer.
English: No clinically relevant effects on heart rate and blood pressure have been observed in clinical trials.
Danish: Ingen klinisk relevante virkninger på hjertefrekvens og blodtryk er observeret i kliniske forsøg.
English: For single use only, one container is sufficient to treat both eyes.
Danish: Én beholder er tilstrækkelig til at behandle begge øjne.
English: 4 weeks after first opening.
Danish: 4 uger efter første åbning.
English: Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called prostamides.
Danish: Bimatoprost efterligner selektivt virkningen af nyopdagede biosyntetiske substanser, som kaldes prostamider.
English: Warnings and precautions:
Danish: Advarsler og forsigtighedsregler
English: If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.
Danish: Såfremt det forhøjede tryk ikke nedsættes, kan det medføre en sygdom, der hedder grøn stær (glaukom), og måske skade Deres syn.
English: This medicine is for single use only and does not contain preservatives.
Danish: Dette lægemiddel er kun til engangsbrug og indeholder ikke konserveringsmidler.
English: Any unused solution should be discarded immediately after use.
Danish: Eventuel ubrugt opløsning skal kasseres umiddelbart efter brug.
English: Your eye contains a clear, watery liquid that feeds the inside of the eye.
Danish: Øjet indeholder en klar, vandig væske, som giver næring til øjet.
English: This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.
Danish: Dette lægemiddel kan anvendes alene eller sammen med øjendråber, som kaldes beta-blokkere, der også nedsætter trykket.
English: The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
Danish: Ændringen i pigmentering skyldes øget melaninindhold i melanocytterne snarere end en stigning i antallet af melanocytter.
English: There is a potential for hair growth to occur in areas where LUMIGAN solution comes repeatedly in contact with the skin surface.
Danish: Der er risiko for hårvækst på områder, hvor LUMIGAN øjendråber gentagne gange kommer i kontakt med huden.
English: Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 l/kg.
Danish: Bimatoprost distribueres moderat i legemsvæv, og den systemiske distributionsvolumen hos mennesker ved stabil tilstand var 0,67 l/kg.
English: Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.
Danish: Bimatoprost gennemgår oxydering, N-deethylering og glucuronisering for at danne en række forskellige metabolitter.
English: Increased iris pigmentation is likely to be permanent.
Danish: Den øgede irispigmentering er sandsynligvis permanent.
English: These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent ocular disease.
Danish: Disse beholdere var utilsigtet blevet kontamineret af patienter, der i de fleste tilfælde havde en anden øjensygdom.
English: For any information about this medicine, please contact the local representative of the marketing authorisation holder.
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
Danish: Anvend ikke flasken, hvis forseglingen på flaskehalsen er brudt, før den tages i brug første gang.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apoteket til råds, før De bruger dette lægemiddel.
English: You must throw away the bottle at the latest four weeks after you first opened it, even if there are still some drops left.
Danish: Flasken skal kasseres senest fire uger efter første åbning, selv om der stadig er nogle øjendråber tilbage.
English: The change may be more noticeable if you are only treating one eye.
Danish: Forandringen bemærkes mere, såfremt kun det ene øje behandles.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj og betjene maskiner
English: Other side effects reported with eye drops containing phosphates.
Danish: Andre bivirkninger indberettet fra øjendråber, der indeholder fosfater.
English: It is unknown whether bimatoprost is excreted in human breast milk.
Danish: Det vides ikke, om bimatoprost udskilles i human mælk.
English: Patients using LUMIGAN with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
Danish: Patienter, der bruger LUMIGAN sammen med andre prostaglandinanaloger, skal monitoreres for ændringer i intraokulært tryk.
English: CARTON CONTAINING THREE BOTTLES
Danish: ÆSKE MED TRE FLASKER
English: This reduces the pressure inside the eye.
Danish: Hermed nedsættes trykket i øjet.
English: Hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis
Danish: Immunsystemet ikke kendt overfølsomhedsreaktion, inklusive tegn og symptomer på øjenallergi og allergisk dermatitis
English: The plasma protein binding of bimatoprost is approximately 88 %.
Danish: Plasmaproteinbindingen af bimatoprost er ca. 88 %.
English: • A feeling that something is in your eye
Danish: • En fornemmelse af at have noget i øjet
English: Bimatoprost is a potent ocular hypotensive agent.
Danish: Bimatoprost er et middel med potent okulær hypotensiv aktivitet.
English: However, this finding is not clinically relevant as systemic exposure for both elderly and young subjects remained very low from ocular dosing.
Danish: Dette resultat er dog ikke klinisk relevant, da systemisk eksponering hos både ældre og unge forsøgspersoner er meget lav ved okulær dosering.
English: Periorbital tissue pigmentation has been reported to be reversible in some patients.
Danish: Periorbital vævspigmentering er rapporteret reversibel hos nogle patienter.
English: If you wear contact lenses, take your lenses out before using this medicine.
Danish: Hvis De bruger kontaktlinser, skal disse tages ud før anvendelse af dette lægemiddel.
English: - if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride.
Danish: - hvis De tidligere har været nødt til at holde op med at bruge øjendråber på grund af en bivirkning ved konserveringsmidlet benzalkoniumchlorid.
English: Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues, ATC code: S01EE03.
Danish: Farmakoterapeutisk klassifikation: Øjenmidler, prostaglandinanaloger, ATC-kode: S01EE03.
English: 5 pack - 12 months
Danish: Pakning med 5 stk. - 12 måneder
English: Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years.
Danish: De farveændringer i iris, der ses ved administration af bimatoprost i øjet, vil muligvis først blive synlige efter adskillige måneder til år.
English: The long term effects of increased iris pigmentation are not known.
Danish: Virkningerne af øget irispigmentering på langt sigt kendes ikke.
English: LUMIGAN has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure.
Danish: LUMIGAN har ikke været undersøgt hos patienter med hjerteblok mere alvorlig end første grad eller ukontrolleret hjerteinsufficiens.
English: • Asthma
Danish: • Astma
English: • Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
Danish: • Symptomer på allergisk reaktion (hævelse, røde øjne og hududslæt)
English: You can also report side effects directly via national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The increased iris pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and not by an increase in melanocyte number.
Danish: Tilsyneladende skyldes stigningen i irispigmentering øget stimulation af melaninproduktion i melanocytter og ikke en stigning i melanocyttallet.
English: Pack contains 3 or 9 aluminium foil pouches, each containing 10 single-dose containers, for a total of 30 or 90 single-dose containers in a carton, respectively.
Danish: Pakningen indeholder 3 eller 9 aluminiumsfolieposer, der hver indeholder 10 enkeltdosisbeholdere, dvs. i alt henholdsvis 30 eller 90 enkeltbeholdere i en karton.
English: The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 l/hr/kg.
Danish: Elimineringshalveringstiden, bestemt efter intravenøs administration, var ca. 45 minutter, den totale blod-clearance var 1,5 l/t/kg.
English: LUMIGAN has not been studied in patients with compromised respiratory function.
Danish: LUMIGAN har ikke været undersøgt hos patienter med nedsat respirationsfunktion.
English: Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation, since these have been observed during treatment with LUMIGAN.
Danish: Før behandlingen påbegyndes, skal patienten oplyses om muligheden for vækst af øjenvipper, mørkfarvning af øjenlågshuden og øget irispigmentering, eftersom dette har været observeret ved behandling med LUMIGAN.
English: Vascular disorders not known hypertension
Danish: Vaskulære sygdomme ikke kendt hypertension
English: Since LUMIGAN contains benzalkonium chloride, monitoring is required with frequent or prolonged use in dry eye patients or where the cornea is compromised.
Danish: Da LUMIGAN indeholder benzalkoniumchlorid kræves tæt opfølgning ved hyppig eller langvarig brug hos patienter med tørre øjne eller ved tilfælde hvor cornea er kompromitteret.
English: Package leaflet: Information for the user
Danish: Indlægsseddel: information til brugeren
English: Approximately 4 % of patients discontinued due to any adverse event in the 12-month study.
Danish: Ca. 4 % af patienterne afbrød behandlingen på grund af bivirkninger i 12 måneders-studiet.
English: Exp: Discard 4 weeks after first opening
Danish: Exp: Kasseres 4 uger efter åbning
English: LUMIGAN has negligible influence on the ability to drive and use machines.
Danish: LUMIGAN påvirker ikke eller i ubetydelig grad evnen til at køre bil og betjene maskiner.
English: Conjunctival hyperaemia, growth of eyelashes, and eye pruritus were statistically significantly higher with bimatoprost than with latanoprost, however, the discontinuation rates due to adverse events were low with no statistically significant difference.
Danish: Konjunktival hyperæmi, vækst af øjenvipper og okulær pruritus forekom signifikant hyppigere med bimatoprost end med latanoprost, men forekomsten af patienter, der udgik på grund af utilsigtede hændelser var lav, og forskellen var ikke statistisk signifikant.
English: Wait 15 minutes after using the drops, and before you put your lenses back in.
Danish: Vent 15 minutter efter drypning, før De sætter kontaktlinserne i igen.
English: Patients with hepatic and renal impairment:
Danish: Patienter med nedsat lever- eller nyrefunktion:
English: Animal studies have shown excretion of bimatoprost in breast milk.
Danish: Dyrestudier har vist udskillelse af bimatoprost i mælk.
English: LUMIGAN should be used with caution in patients with a prior history of significant ocular viral infections (e.g. herpes simplex) or uveitis/iritis.
Danish: LUMIGAN bør anvendes med forsigtighed hos patienter med signifikante okulære virusinfektioner (f.eks. herpes simplex) eller uveitis/iritis i anamnesen.
English: Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 at approximately 0.08 ng/ml and 0.09 ng•hr/ml respectively, indicating that a steady bimatoprost concentration was reached during the first week of ocular dosing.
Danish: Cmax og AUC 0-24t middelværdier var nogenlunde de samme på dag 7 og 14 med hhv. ca. 0,08 ng/ml og 0,09 ng•t/ml, hvilket angiver, at en stabil bimatoprostkoncentration blev opnået i løbet af den første uge af okulær dosering.
English: LUMIGAN should only be applied to the eye.
Danish: LUMIGAN må kun anvendes som øjendråber.
English: Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the level of acid (pH levels) normal.
Danish: Der kan tilsættes små mængder saltsyre eller natriumhydroxid for at holde syreniveauet (pH-niveauet) normalt.
English: Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Danish: Benzalkoniumchlorid, som ofte anvendes som konserveringsmiddel i øjenpræparater, er blevet rapporteret at forårsage punktformet keratopati og/eller toksisk ulcerøs keropati.
English: If you are worried, talk to your doctor or pharmacist.
Danish: Hvis De er bekymret, så kontakt Deres læge eller apotek.
English: Respiratory, thoracic and mediastinal disorders not known asthma, asthma exacerbation, COPD exacerbation and dyspnoea
Danish: Luftveje, thorax og mediastinum ikke kendt astma, forværring af astma, forværring af KOL og dyspnø
English: On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml eye drops, solution usage, the most frequently reported treatment-related adverse events were: growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 years and 2% at 3 years, conjunctival hyperaemia (mostly trace to mild and thought to be of a noninflammatory nature) in up to 44% in the first year with the incidence of new reports decreasing to 13% at 2 years and 12% at 3 years and ocular pruritus in up to 14% of patients in the first year with the incidence of new reports decreasing to 3% at 2 years and 0% at 3 years.
Danish: Ved at kombinere data fra fase III monoterapi og supplerende behandling med LUMIGAN 0,3 mg/ml øjendråber var de hyppigst indberettede behandlingsrelaterede bivirkninger: vækst af øjenvipper hos op til 45% i løbet af det første år, hvorefter incidensen af nye indberetninger faldt til 7% efter 2 år og 2% efter 3 år, konjunktival hyperæmi (for det meste en antydning eller en mild form, som anses for ikke-inflammatorisk) hos op til 44% i løbet af det første år, hvorefter incidensen af nye indberetninger faldt til 13% efter 2 år og 12% efter 3 år, og okulær pruritus hos op til 14% af patienterne i løbet af det første år, hvorefter incidensen af nye indberetninger faldt til 3% efter 2 år og 0% efter 3 år.
English: To help you remember, write down the date you opened it in the space on the box.
Danish: For at huske datoen for første åbning bør De skrive denne dato ned i feltet på kartonen.
English: • Worsening of vision
Danish: • Forværring af synet
English: The mechanism of action by which bimatoprost reduces intraocular pressure in humans is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.
Danish: Den virkningsmekanisme, hvorved bimatoprost nedsætter det intraokulære tryk hos mennesker, er ved at øge kammervandsafløbet gennem trabekelværket og øge det uveosclerale afløb.
English: 6.5 Nature and contents of container
Danish: 6.5 Emballage art og indhold
English: Most were ocular, mild to moderate, and none was serious: With each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: De fleste var okulære, lette til moderate, og ingen var alvorlige: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: A decision must be made whether to discontinue breastfeeding or to discontinue from LUMIGAN 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 LUMIGAN seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: 30 pack - 18 months
Danish: Pakning med 30 stk. - 18 måneder
English: 90 pack - 18 months
Danish: Pakning med 90 stk. - 18 måneder
English: Remove contact lenses before use.
Danish: Kontaktlinser skal tages ud før anvendelse.
English: If you stop using LUMIGAN the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.
Danish: Hvis De holder op med at anvende LUMIGAN kan trykket i Deres øje stige, tal derfor med deres læge inden denne behandling afbrydes.
English: Eye irritation and discolouration of the soft contact lenses may also occur because of the presence of benzalkonium chloride.
Danish: Øjenirritation og misfarvning af de bløde kontaktlinser kan også opstå på grund af indholdet af benzalkoniumchlorid.
English: For single use only
Danish: Kun til engangsbrug
English: MARKETING AUTHORISATION NUMBER
Danish: MARKEDSFØRINGSTILLADELSESNUMMER
English: • An allergic reaction in the eye
Danish: • En allergisk reaktion i øjet
English: Take one single-dose container from the pouch and hold it upright (with the cap pointing upwards) and twist off the cap.
Danish: Tag én enkeltdosisbeholder fra posen, og hold enkeltdosisbeholderen lodret (med hætten pegende opad) og vrid hætten af.
English: This medicine does not contain a preservative.
Danish: Dette lægemiddel indeholder ikke konserveringsmiddel.
English: No functional or microscopic changes related to the periocular effects were observed, and the mechanism of action for the periocular changes is unknown.
Danish: Der blev ikke observeret funktionsmæssige eller mikroskopiske ændringer med relation til de periokulære virkninger, og virkningsmekanismen bag de periokulære forandringer kendes ikke.
English: No functional or microscopic changes related to the periocular effects have been observed, and the mechanism of action for the periocular changes is unknown.
Danish: Der er ikke observeret funktionsmæssige eller mikroskopiske ændringer med relation til de periokulære virkninger, og virkningsmekanismen bag de periokulære forandringer kendes ikke.
English: Sodium chloride
Danish: Natriumchlorid
English: LUMIGAN should be used with caution in patients predisposed to low heart rate or low blood pressure.
Danish: LUMIGAN bør anvendes med forsigtighed hos patienter, der er prædisponerede for langsomt hjerteslag eller lavt blodtryk.
English: Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing.
Danish: Bimatoprost er den vigtigste cirkulerende art i blodet, ved den systemiske cirkulation efter okulær dosering.
English: No information is available on overdose in humans; overdose is unlikely to occur after ocular administration.
Danish: Der foreligger ingen oplysninger om overdosering hos mennesker, og det er usandsynligt, at der vil opstå overdosering efter okulær anvendelse.
English: Throw away the single-dose container after you have used it, even if there is some solution left.
Danish: Kassér enkeltdosisbeholderen efter brug, også selvom der er opløsning tilbage.
English: Discard 4 weeks after first opening Exp:
Danish: Kasseres 4 uger efter åbning EXP:
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency we
Danish: Denne indlægsseddel findes på alle EU-/EØS-sprog på Det Europæiske Lægemiddelagenturs hjemmeside.
English: LUMIGAN may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too.
Danish: LUMIGAN kan måske forårsage, at Deres øjenvipper bliver mørkere og vokser, samt få huden omkring øjenlåget til at blive mørkere.
English: Clinical efficacy
Danish: Klinisk effekt
English: The solution should be used immediately after opening.
Danish: Øjendråberne skal anvendes umiddelbart efter åbning.
English: If you use LUMIGAN with another eye medicine, wait at least five minutes between using LUMIGAN and the other eye medicine.
Danish: Hvis De bruger anden øjenmedicin, skal der gå mindst fem minutter imellem, at De bruger LUMIGAN og den anden øjenmedicin.
English: To help prevent infections and avoid eye injury, do not let the tip of the bottle touch your eye or anything else.
Danish: For at undgå infektioner og øjenskade må flaskespidsen ikke berøre øjet eller andet.
English: Pack contains 5-single-dose containers in a carton.
Danish: Pakningen indeholder 5 enkeltdosisbeholdere i en karton.
English: Bimatoprost did not impair fertility in rats up to doses of 0.6 mg/kg/day (at least 103-times the intended human exposure).
Danish: Bimatoprost nedsatte ikke fertiliteten hos rotter, der fik doser op til 0,6 mg/kg/døgn (mindst 103 gange den tilsigtede humane eksponering).
English: LUMIGAN eye drops are used to reduce high pressure in the eye.
Danish: LUMIGAN øjendråber anvendes til at sænke forhøjet tryk i øjet.
English: If LUMIGAN is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 100 mg/kg/day did not produce any toxicity.
Danish: Såfremt LUMIGAN ved et uheld indtages, kan følgende informationer være nyttige: i 2-ugers perorale rotte- og museforsøg fremkaldte doser på op til 100 mg/kg/dag ikke nogen toksicitet.
English: Benzalkonium chloride
Danish: Benzalkoniumchlorid
English: Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).
Danish: Reduktion af forhøjet intraokulært tryk ved kronisk åbenvinklet glaukom og okulær hypertension hos voksne (som monoterapi eller som supplerende behandling til beta-blokkere).
English: While there is limited information available on patients with a history of asthma or COPD, there have been reports of exacerbation of asthma, dyspnoea and COPD, as well as reports of asthma, in post marketing experience.
Danish: Mens de foreliggende oplysninger om patienter med astma eller KOL i anamnesen er begrænsede, er der efter markedsføringen indberettet forværring af astma, dyspnø og KOL samt indberettet astma.
English: To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else.
Danish: Lad ikke den åbne ende af enkeltdosisbeholderen berøre øjet eller andet.
English: There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues (see section 4.4).
Danish: Der er en risiko for, at den IOP-sænkende effekt af prostaglandinanaloger (f.eks. LUMIGAN) nedsættes hos patienter med glaukom eller okulær hypertension, hvis de bruges sammen med andre prostaglandinanaloger (se pkt 4.4).
English: Since LUMIGAN 0.1 mg/ml contains 200 ppm benzalkonium chloride (four times the concentration in bimatoprost 0.3 mg/ml eye drops), it should be used with caution in dry eye patients, in patients where the cornea may be compromised and in patients taking multiple BAK-containing eye drops.
Danish: Da LUMIGAN 0,1 mg/ml indeholder 200 ppm benzalkoniumchlorid (fire gange så høj koncentration som i bimatoprost 0,3 mg/ml øjendråber), kræves tæt opfølgning ved brug hos patienter med tørre øjne, hos patienter, hvor cornea er kompromitteret, samt hos patienter, der bruger flere øjendråber, der indeholder benzalkoniumchlorid.