FrancophonIA/ELRC3.0 huggingface dataset:
English: Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.
Danish: - Reaktive luftvejssygdomme inklusive asthma bronchiale eller asthma bronchiale i anamnesen, alvorlig kronisk obstruktiv lungesygdom.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og karcinogenicitet.
English: Use any eye ointment or eye gel last.
Danish: Øjensalve eller øjengel skal bruges sidst.
English: Patients using GANFORT with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
Danish: Patienter, der bruger GANFORT sammen med andre prostaglandinanaloger, bør monitoreres for ændringer i intraokulære tryk.
English: A 12-week (double-masked, randomized, parallel group) clinical study compared the efficacy and safety of GANFORT single-dose with GANFORT (multi-dose formulation) in patients with glaucoma or ocular hypertension.
Danish: Et 12-ugers (dobbeltblindet, randomiseret, parallelgruppe-) klinisk studier sammenlignede effekten og sikkerheden af GANFORT enkeltdosis med GANFORT (flerdosisformulering) hos patienter med glaukom eller okulær hypertension.
English: • Fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
Danish: • Besvimelse, slagtilfælde, nedsat blodtilførsel til hjernen, forværring af myasthenia gravis (øget muskelsvækkelse), prikkende fornemmelse
English: GANFORT should not be used in children and teenagers under 18.
Danish: GANFORT bør ikke bruges af børn og unge under 18 år.
English: Throw away the single-dose container after you have used it, even if there is some solution left.
Danish: Smid enkeltdosisbeholderen væk, når De har brugt den, også selvom, der er øjendråber tilbage i den.
English: In two 12-month studies where systemic absorption was measured, no accumulation was observed with either of the individual components.
Danish: I de to 12-måneders studier med måling af systemisk absorption sås ingen akkumulering af de enkelte komponenter.
English: Timolol is a beta1 and beta2 non-selective adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic (membrane-stabilising) activity.
Danish: Timolol er et beta1 og beta2 nonselektivt adrenergt receptorblokerende middel uden signifikant intrinsisk sympatomimetisk, direkte hjertedepressiv eller lokalanæstetisk (membranstabiliserende) virkning.
English: Periorbital tissue pigmentation has been reported to be reversible in some patients.
Danish: Ifølge rapporter er periorbital vævspigmentering reversibel hos nogle patienter.
English: However, consideration should be given to the likelihood of compliance when considering either morning or evening dosing (see section 5.1).
Danish: Der skal dog tages hensyn til sandsynligheden for komplians, når enten morgen- eller aftendosering overvejes (se pkt.
English: In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease the IOP-lowering effect.
Danish: Studier af bimatoprost 0,3 mg/l hos patienter med glaukom eller okulær hypertension har vist, at hyppigere eksponering af øjet for mere end 1 dosis bimatoprost dagligt kan nedsætte den IOPsænkende virkning.
English: Absorption of timolol may cause similar undesirable effects as seen with systemic beta-blocking agents.
Danish: Absorption af timolol kan forårsage samme uønskede virkninger som dem, der ses med systemiske betablokkere.
English: GANFORT single-dose also achieved equivalent IOP-lowering efficacy to GANFORT (multi-dose formulation) in average eye and worse eye IOP at each follow-up timepoint at weeks 2, 6 and 12.
Danish: GANFORT enkeltdosis opnåede også samme IOP-sænkende effekt som GANFORT (flerdosisformulering) i det gennemsnitlige øjes og det dårligste øjes IOP på alle kontroltidspunkter ved uge 2, 6 og 12.
English: GANFORT can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
Danish: GANFORT kan påvirke eller påvirkes af anden medicin, som De bruger, herunder andre øjendråber til behandling af grøn stær (glaukom).
English: Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion.
Danish: Kontaktlinser bør tages ud før inddrypning og kan tidligst isættes igen 15 minutter efter applikation.
English: Ask your doctor for advice before taking any medicine during breast-feeding.
Danish: Spørg Deres læge til råds, inden De bruger nogen form for medicin, mens De ammer.
English: If GANFORT single-dose is administered until delivery, the neonate should be carefully monitored during the first days of life.
Danish: Hvis GANFORT enkeltdosis administreres frem til fødslen, skal den nyfødte overvåges nøje i løbet af de første levedage.
English: Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost and so may possibly be seen with GANFORT.
Danish: Yderligere bivirkninger er set hos patienter, der brugte øjendråber med timolol eller bimatoprost, og kan derfor forekomme med GANFORT.
English: It is known that ophthalmic beta-blockers (like e.g. timolol) in some cases can cause systemic side effects.
Danish: Det er kendt, at oftalmologiske betablokkere (som f.eks. timolol) i nogle tilfælde kan forårsage systemiske bivirkninger.
English: GANFORT single-dose should not be used during pregnancy unless clearly necessary.
Danish: GANFORT enkeltdosis bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: After once daily ocular administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ml) within 1.5 hours after dosing.
Danish: Efter 1 daglig okulær administration af 1 dråbe 0,03 % bimatoprost i begge øjne i 2 uger toppede blodkoncentrationer inden for 10 minutter efter dosering og faldt til under den laveste påviselige grænse (0,025 mg/ml) inden for 1,5 time efter applikation.
English: If GANFORT is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses of bimatoprost up to 100 mg/kg/day did not produce any toxicity.
Danish: Såfremt GANFORT indtages ved et uheld, kan følgende informationer være nyttige: I 2-ugers orale rotte- og musestudier fremkaldte doser på op til 100 mg/kg/dag ikke toksicitet.
English: No specific interaction studies have been performed with the bimatoprost / timolol fixed combination.
Danish: Der er ikke udført specifikke interaktionsstudier med bimatoprost/timolol i fast kombinationsforhold.
English: Based on 12-month clinical data, the most commonly reported adverse reaction was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 26% of patients and led to discontinuation in 1.5% of patients.
Danish: Ud fra 12 måneders kliniske data var den hyppigst indberettede bivirkning konjunktival hyperæmi (for det meste kun en antydning eller en let form, som anses for ikke-inflammatorisk) hos ca. 26 % af patienterne, og den førte til seponering hos 1,5 % af patienterne.
English: Do not use the drops while your contact lenses are in your eyes.
Danish: De må ikke bruge dråberne med kontaktlinser i øjnene.
English: Do not use GANFORT if you are pregnant unless your doctor still recommends it.
Danish: Brug ikke GANFORT, hvis De er gravid, medmindre lægen alligevel anbefaler det.
English: Symptoms of systemic timolol overdose include: bradycardia, hypotension, bronchospasm, headache, dizziness, shortness of breath, and cardiac arrest.
Danish: Symptomer på systemisk overdosering af timolol omfatter: bradykardi, hypotension, bronkospasme, hovedpine, svimmelhed, kortåndethed og hjertestop.
English: Metabolism and nutrition disorders hypoglycaemia1
Danish: Metabolisme og ernæring hypoglykæmi1
English: 10 single-dose containers.
Danish: 10 enkeltdosisbeholdere.
English: Fertility There are no data on the effects of GANFORT single-dose on human fertility.
Danish: Fertilitet Der foreligger ingen data om virkningen af GANFORT enkeltdosis på fertiliteten hos mennesker.
English: GANFORT has negligible influence on the ability to drive and use machines.
Danish: GANFORT påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine, medicines to treat diabetes, quinidine (used to treat heart conditions and some types of malaria) or medicines to treat depression known as fluoxetine and paroxetine.
Danish: Fortæl det til lægen, hvis De tager eller har tænkt Dem at tage blodtrykssænkende medicin, hjertemedicin, medicin til behandling af sukkersyge (diabetes), quinidin (anvendes til at behandle hjertelidelser og visse typer malaria) eller medicin mod depression, som kaldes fluoxetin og paroxetin.
English: Increased brown iris pigmentation has also been observed during treatment with GANFORT (multi-dose formulation).
Danish: Øget brun irispigmentering er også observeret under behandling med GANFORT (flerdosisformulering).
English: After 12 months of treatment with GANFORT (multi-dose formulation), the incidence of iris pigmentation was 0.2%.
Danish: Efter 12 måneders behandling med GANFORT (flerdosisformulering) var incidensen af irispigmentering 0,2 %.
English: Small amounts of hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH (acidity) level.
Danish: Der kan være tilsat små mængder saltsyre eller natriumhydroxid, så opløsningen har den rette surhedsgrad (pH).
English: GANFORT single-dose should not be used in children and teenagers under 18.
Danish: GANFORT enkeltdosis bør ikke bruges af børn og unge under 18 år.
English: Gently pull down the lower eyelid until there is a small pocket.
Danish: Træk forsigtigt ned i det nederste øjenlåg, så der dannes en lille lomme.
English: Once the single-dose container is removed from the pouch use within 7 days.
Danish: Når enkeltdosisbeholderen er fjernet fra posen, skal den bruges inden for 7 dage.
English: The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml.
Danish: GANFORT fås i følgende pakningsstørrelser: æske med 1 eller 3 flasker a 3 ml.
English: Monkeys administered ocular bimatoprost concentrations of ≥0.03% daily for 1 year had an increase in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper and/or lower sulcus and widening of the palpebral fissure.
Danish: Hos aber, som fik okulært bimatoprost i koncentrationer på ≥0,03 % dagligt i 1 år, sås en stigning i irispigmentering og reversibel dosisafhængig periokulær virkning, som var karakteriseret ved prominent øvre og nedre sulcus og udvidelse af øjenspalten.
English: Do not stop using GANFORT single-dose without speaking to your doctor.
Danish: De må ikke holde op med at bruge GANFORT enkeltdosis uden at tale med lægen.
English: The following side effects may be seen with GANFORT (single-dose and/or multi-dose):
Danish: Følgende bivirkninger kan forekomme med GANFORT (enkeltdosis og/eller flerdosis):
English: This medicine does not contain a preservative.
Danish: Dette lægemiddel indeholder ingen konserveringsmidler.
English: The following side effects may be seen with GANFORT (multi-dose and/or single-dose):
Danish: Følgende bivirkninger kan forekomme med GANFORT (flerdosis og/eller enkeltdosis):
English: Timolol is partially metabolised by the liver with timolol and its metabolites excreted by the kidney.
Danish: Timolol metaboliseres delvist i leveren, og timolol og dets metabolitter udskilles via nyrerne.
English: Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions as seen with systemic beta-blockers may occur.
Danish: På grund af den beta-adrenerge komponent, timolol, kan der forekomme samme type kardiovaskulære, pulmonale og andre bivirkninger, som ses ved systemiske betablokkere.
English: Nervous system disorders syncope1, cerebrovascular accident1, increase in signs and symptoms of myasthenia gravis1, paraesthesia1, cerebral ischaemia1
Danish: Nervesystemet synkope1, cerebrovaskulært attak1, øget forekomst af tegn og symptomer på myasthenia gravis1, paræstesi1, cerebral iskæmi1
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Common blepharal pigmentation2, hirsutism2, skin hyperpigmentation (periocular).
Danish: Øjenlågspigmentering2, hirsutisme2, hyperpigmentering af hud (periokulær)
English: The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.
Danish: Incidensen af systemiske bivirkninger efter topisk oftalmisk administration er lavere end ved systemisk administration.
English: It should be administered at the same time each day.
Danish: GANFORT skal administreres på samme tidspunkt hver dag.
English: If you forget to use GANFORT single-dose, use a single drop as soon as you remember, and then go back to your regular routine.
Danish: Hvis De glemmer at bruge GANFORT enkeltdosis, inddryppes en enkelt dråbe, så snart De husker det. Fortsæt derefter den normale rutine.
English: In two 12-month studies of GANFORT (multi-dose formulation) in which systemic absorption was measured, no accumulation was observed of either of the individual components.
Danish: I de to 12-måneders studier af GANFORT (flerdosisformulering) med måling af systemisk absorption sås ingen akkumulering af de enkelte komponenter.
English: Based on studies of GANFORT (multi-dose formulation), the IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of bimatoprost (once daily) and timolol (twice daily).
Danish: Baseret på studier med GANFORT (flerdosisformulering) er GANFORTs IOP-sænkende virkning ikke ringere end virkningen af samtidig behandling med bimatoprost (en gang dagligt) og timolol (to gange dagligt).
English: GANFORT single-dose
Danish: GANFORT enkeltdosis
English: Do not use GANFORT single-dose if you are pregnant unless your doctor still recommends it.
Danish: Brug ikke GANFORT enkeltdosis, hvis De er gravid, medmindre lægen alligevel anbefaler det.
English: If you use more GANFORT than you should, it is unlikely to cause you any serious harm.
Danish: Hvis De har brugt for meget GANFORT, er det usandsynligt, at det skulle forårsage alvorlige skader.
English: • An increase in blood test results that show how your liver is working
Danish: • Stigning i værdier fra blodprøver til bestemmelse af leverfunktion
English: If you forget to use GANFORT
Danish: Hvis De har glemt at bruge GANFORT
English: These two components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone.
Danish: Disse to komponenter nedsætter forhøjet intraokulært tryk (IOP) gennem komplementære virkningsmekanismer, og den samlede virkning medfører en øget trykreduktion i forhold til hvert af stofferne givet som monoterapi.
English: GANFORT medicinal product
Danish: Lægemidlet GANFORT
English: GANFORT contains Benzalkonium chloride
Danish: GANFORT indeholder benzalkoniumchlorid
English: The dose should not exceed one drop in the affected eye(s) daily.
Danish: Dosis må ikke overstige 1 dråbe i det/de afficerede øje/øjne dagligt.
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 agent.
Danish: Virkningen på det intraokulære tryk eller de kendte virkninger af systemiske betablokkere kan blive forstærket, når timolol gives til patienter, der allerede får en systemisk betablokker.
English: Opened (3)
Danish: Åbnet (3)
English: After ocular administration of a 0.5% eye drops solution in humans undergoing cataract surgery, peak timolol concentration was 898 ng/ml in the aqueous humour at one hour post-dose.
Danish: Efter okulær administration af en 0,5 % øjendråbeopløsning hos personer, der blev opereret for katarakt var den maksimale koncentration af timolol 898 ng/ml i kammervand 1 time efter administration.
English: Opened (1)
Danish: Åbnet (1)
English: Vascular disorders hypotension1, hypertension2, Raynaud's phenomenon1, cold hands and feet1
Danish: Vaskulære sygdomme hypotension1, hypertension2, Raynauds syndrom1, kolde hænder og fødder1
English: If you stop using GANFORT
Danish: Hvis De holder op med at bruge GANFORT
English: Benzalkonium chloride may cause eye irritation and is also known to discolour soft contact lenses.
Danish: Benzalkoniumchlorid kan irritere øjnene og er kendt for at misfarve bløde kontaktlinser.
English: GANFORT single-dose eye drops are used to treat high pressure in the eye in adults, including the elderly.
Danish: GANFORT enkeltdosis øjendråber anvendes til behandling af forhøjet tryk i øjet hos voksne, inklusive ældre.
English: Based on a 12-week study of GANFORT single-dose administered once daily, the most commonly reported adverse reaction with GANFORT single-dose was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 21% of patients and led to discontinuation in 1.4% of patients.
Danish: Ud fra et 12-ugers studie med GANFORT enkeltdosis administreret én gang dagligt var den hyppigst indberettede bivirkning med GANFORT enkeltdosis konjunktival hyperæmi (for det meste kun en antydning eller en let form, som anses for ikke-inflammatorisk) hos ca. 21 % af patienterne, og den førte til seponering hos 1,4 % af patienterne.
English: • Red scaly patches on skin; skin rash
Danish: • Røde, skællede pletter på huden, udslæt på huden
English: Pharmacotherapeutic group: Ophthalmological,- beta-blocking agents - ATC code: S01ED51
Danish: Farmakoterapeutisk klassifikation: ophthalmologica - beta-blokerende midler - ATC-kode: S01ED51
English: What you need to know before you use GANFORT Do not use GANFORT eye drops, solution
Danish: Det skal De vide, før De begynder at bruge GANFORT Brug ikke GANFORT øjendråber, opløsning
English: Epidemiological studies have not revealed malformative effects but have shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route.
Danish: Epidemiologiske studier har ikke dokumenteret bivirkninger i form af misdannelser, men har påvist en risiko for intrauterin væksthæmning ved oral administration af betablokkere.
English: Uncommon dyspnoea
Danish: Ikke almindelig dyspnø
English: Eye drops, solution, in single-dose container.
Danish: Øjendråber, opløsning, i enkeltdosisbeholder.
English: Affecting other parts of the body shortness of breath.
Danish: Påvirkning af andre dele af kroppen Kortåndethed.
English: Psychiatric disorders depression1, memory loss1, hallucination1
Danish: Psykiske forstyrrelser depression1, hukommelsestab1, hallucination1
English: Therefore caution should be used in treating such patients.
Danish: Behandling af disse patienter bør derfor foregå med forsigtighed.
English: GANFORT works by reducing the production of liquid and also increasing the amount of liquid that is drained.
Danish: GANFORT virker ved at nedsætte dannelsen af væske og samtidig øge den mængde væske, der løber ud.
English: GANFORT single-dose may cause your eyelashes to darken and grow, and cause the skin around the eye to darken too.
Danish: GANFORT enkeltdosis kan måske forårsage, at Deres øjenvipper bliver mørkere og vokser, samt få huden omkring øjenlåget til at blive mørkere.
English: Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Danish: Reduktion af det intraokulære tryk hos voksne patienter med åbenvinklet glaukom eller okulær hypertension, som ikke responderer tilstrækkeligt på lokale betablokkere eller prostaglandinanaloger.
English: The IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of bimatoprost (once daily) and timolol (twice daily).
Danish: GANFORTs IOT-sænkende virkning er ikke ringere end virkningen af samtidig behandling med bimatoprost (en gang dagligt) og timolol (to gange dagligt).
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 atopi eller alvorlige anafylaktiske reaktioner på en række allergener i anamnesen udvise manglende respons på den sædvanlige dosis adrenalin til behandling af anafylaktiske reaktioner.
English: • Diarrhoea; stomach pain; feeling and being sick; indigestion; dry mouth
Danish: • Diarré, mavesmerter, kvalme og opkastning, fordøjelsesbesvær, tør mund
English: Each single-dose container contains 0.4 ml solution.
Danish: Hver enkeltdosisbeholder indeholder 0,4 ml øjendråber.
English: If you use GANFORT single-dose with another eye medicine, leave at least 5 minutes between putting in GANFORT single-dose and the other medicine.
Danish: Hvis De bruger GANFORT enkeltdosis sammen med anden øjenmedicin, skal der gå mindst 5 minutter mellem, at De påfører GANFORT enkeltdosis og den anden medicin.
English: The majority of adverse reactions reported in clinical studies using GANFORT were ocular, mild in severity and none were serious.
Danish: De fleste bivirkninger, der er rapporteret i kliniske studier med GANFORT, var okulære og af lettere grad, og ingen var alvorlige.
English: No new adverse reactions specific for GANFORT have been observed in clinical studies.
Danish: Der er ikke observeret nye bivirkninger specifikt for GANFORT i kliniske studier.
English: There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics (including amiodarone) and digitalis glycosides.
Danish: Der er potentiale for additiv virkning, som fører til hypotension og/eller markant bradykardi, når oftalmiske betablokkeropløsninger administreres samtidig med orale calciumantagonister, guanethidin, beta-adrenerge blokkere, parasympatomimetika, antiarytmika (inklusive amiodaron) og digitalisglykosider.
English: GANFORT may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too.
Danish: GANFORT kan måske forårsage, at Deres øjenvipper bliver mørkere og vokser, samt få huden omkring øjenlåget til at blive mørkere.
English: To avoid contamination, do not let the tip of the bottle touch your eye or anything else.
Danish: For at undgå infektioner må dråbespidsen ikke berøre øjet eller andet.
English: • Decreased sensation of your eye surface; double vision; drooping eyelid; separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye; inflammation of the surface of the eye, bleeding in the back of the eye (retinal bleeding), inflammation within the eye, increased blinking
Danish: • Nedsat følelse i øjets overflade, dobbeltsyn, nedhængende øjenlåg, adskillelse af et af lagene inden i øjeæblet efter kirurgi for at nedsætte trykket i øjet, betændelse i øjets overflade, blødning bagtil i øjet (retinablødning), betændelse i øjet, øget blinken