FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommended dosage in adults (including older people) The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered either in the morning or in the evening.
Danish: Anbefalet dosering til voksne (inklusive ældre mennesker) Den anbefalede dosis er 1 dråbe GANFORT i det eller de afficerede øjne en gang dagligt inddryppet enten om morgenen eller om aftenen.
English: Any unused solution should be discarded immediately after use.
Danish: Eventuelle ubrugte øjendråber skal kasseres umiddelbart efter brug.
English: 1adverse reactions only observed with Ganfort single-dose formulation 2adverse reactions only observed with Ganfort multi-dose formulation
Danish: 1 bivirkninger, der kun er set ved GANFORT enkeltdosisformulering 2 bivirkninger, der kun er set ved GANFORT flerdosisformulering
English: Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Danish: Der er lejlighedsvist rapporteret om mydriasis som følge af samtidig brug af oftalmiske betablokkere og adrenalin (epinefrin).
English: Table 1 presents the adverse reactions that have been reported during clinical studies with all GANFORT formulations (multi-dose and single-dose) (within each frequency grouping, adverse reactions are presented in order of decreasing seriousness) or in the post-marketing period.
Danish: Tabel 1 viser de bivirkninger, der blev indberettet under kliniske studier med alle GANFORTformuleringer (flerdosis og enkeltdosis) (inden for hver hyppighed angives bivirkningerne efter faldende sværhedsgrad) eller i perioden efter markedsføringen.
English: Opened (2)
Danish: Åbnet (2)
English: Your doctor will prescribe you GANFORT single-dose when other eye drops containing beta-blockers or prostaglandin analogues have not worked sufficiently on their own.
Danish: Deres læge vil ordinere GANFORT enkeltdosis til Dem, når andre øjendråber med betablokkere eller prostaglandinanaloger ikke har virket tilstrækkeligt alene.
English: Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3).
Danish: I dyrestudier med timolol er der påvist reproduktionstoksicitet ved doser, der var signifikant højere end dem, der skulle anvendes i klinisk brug(se pkt.
English: GANFORT single-dose has negligible influence on the ability to drive and use machines.
Danish: GANFORT enkeltdosis påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: This high pressure can lead to glaucoma.
Danish: Dette forhøjede tryk kan medføre grøn stær.
English: The adverse reactions reported in clinical studies using GANFORT were limited to those earlier reported for either of the single active substances bimatoprost and timolol.
Danish: Bivirkningerne, der er rapporteret i kliniske studier med GANFORT, har været begrænset til de bivirkninger, der tidligere er rapporteret for hvert af de respektive aktive indholdsstoffer bimatoprost og timolol.
English: All containers should be kept in the pouch and carton to protect from light and moisture and discarded 10 days after first opening the pouch.
Danish: Alle beholderne skal opbevares i posen og æsken for at beskytte mod lys og fugt og skal kasseres 10 dage efter den første åbning af posen.
English: Beta-adrenergic blocking medicinal products should be administered with caution in patients subject to spontaneous hypoglycemia or to patients with labile diabetes as beta-blockers may mask the signs and symptoms of acute hypoglycemia.
Danish: Adrenerge beta-receptorblokkere bør anvendes med forsigtighed til patienter, der lider af spontan hypoglykæmi, eller til patienter med labil diabetes, da betablokkere kan maskere symptomer på akut hypoglykæmi.
English: GANFORT single-dose works by reducing the production of liquid and also increasing the amount of liquid that is drained.
Danish: GANFORT enkeltdosis virker ved at nedsætte dannelsen af væske og samtidig øge den mængde væske, der løber ud.
English: GANFORT 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: GANFORT bør anvendes med forsigtighed til patienter med mild/moderat kronisk obstruktiv lungesygdom (KOL), og kun hvis den potentielle fordel opvejer den potentielle risiko.
English: Packs contain 3 or 9 foil pouches, each containing 10 single-dose containers, for a total of 30 or 90 single-dose containers in a carton, respectively.
Danish: Pakningerne indeholder 3 eller 9 folieposer, som hver indeholder 10 enkeltdosisbeholdere, hvilket giver henholdsvis 30 eller 90 enkeltdosisbeholdere i alt.
English: Always use GANFORT exactly as your doctor or pharmacist has told you.
Danish: Brug altid GANFORT nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Your doctor will prescribe you GANFORT when other eye drops containing beta-blockers or prostaglandin analogues have not worked sufficiently on their own.
Danish: Deres læge vil ordinere GANFORT til Dem, når andre øjendråber med betablokkere eller prostaglandinanaloger ikke har virket tilstrækkeligt alene.
English: All single-dose containers should be kept in the pouch and discarded after 10 days from the first opening of the pouch.
Danish: Alle enkeltdosisbeholderne skal opbevares i posen og skal kasseres 10 dage efter den første åbning af posen.
English: If you use more GANFORT single-dose than you should, it is unlikely to cause you any serious harm.
Danish: Hvis De har brugt for meget GANFORT enkeltdosis, er det usandsynligt, at det skulle forårsage alvorlige skader.
English: Plasma bimatoprost and timolol concentrations were determined in a crossover study comparing the monotherapy treatments to GANFORT treatment in healthy subjects.
Danish: Plasmakoncentrationer af bimatoprost og timolol blev bestemt i et crossover-studie med sammenligning af monoterapibehandling og GANFORT-behandling hos raske forsøgspersoner.
English: After 12 months treatment with GANFORT, the incidence of iris pigmentation was 0.2%.
Danish: Efter 12 måneders behandling med GANFORT var incidensen af irispigmentering 0,2 %.
English: Recommended dosage in adults (including older people) The recommended dose is one drop of GANFORT single-dose in the affected eye(s) once daily, administered either in the morning or in the evening.
Danish: Anbefalet dosering til voksne (inklusive ældre mennesker) Den anbefalede dosis er 1 dråbe GANFORT enkeltdosis i det eller de afficerede øjne en gang dagligt inddryppet enten om morgenen eller om aftenen.
English: Before treatment is initiated, patients should be informed of the possibility of eyelash growth, and periorbital skin hyperpigmentation since these have been observed during treatment with GANFORT single-dose.
Danish: Før behandlingen påbegyndes, skal patienten oplyses om risikoen for vækst af øjenvipper, periorbital hyperpigmentering af huden, eftersom dette har været observeret ved behandling med GANFORT (flerdosisformulering).
English: White opaque low-density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml.
Danish: Hvide, uigennemsigtige lavdensitets polyethylenflasker med polystyrenskruelåg.
English: Macular oedema, including cystoid macular oedema has been reported with GANFORT (multi-dose formulation).
Danish: Makulaødem, herunder cystoidt makulaødem er forekommet med GANFORT (flerdosisformulering).
English: Keep the singledose containers in the pouch and place the pouch back in carton in order to protect against light and moisture.
Danish: Opbevar enkeltdosisbeholderne i posen, og læg posen tilbage i æsken, for at beskytte dem mod lys og fugt.
English: A topical overdose with GANFORT is not likely to occur or to be associated with toxicity.
Danish: Det er ikke sandsynligt, at der vil forekomme lokal overdosering med GANFORT, eller at dette vil være forbundet med toksicitet.
English: Contents of the pack and other information What GANFORT contains
Danish: Pakningsstørrelser og yderligere oplysninger GANFORT indeholder:
English: Affecting the eye cystoid macular oedema (swelling of the retina within the eye leading to worsening vision), eye swelling, blurred vision.
Danish: Påvirkning af øjet cystoidt makulaødem (hævelse af nethinden i øjet, hvilket fører til nedsat syn), hævelse af øjet, sløret syn.
English: Pack contains 1 foil pouch containing 5 single-dose containers in a carton.
Danish: Pakningen indeholder 1 foliepose med 5 enkeltdosisbeholdere i en æske.
English: Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Danish: Hornhindeforkalkning i forbindelse med brugen af øjendråber, som indeholder phosphat er i meget sjældne tilfælde rapporteret hos patienter med markant beskadigede hornhinder.
English: If you use GANFORT with another eye medicine, leave at least 5 minutes between putting in GANFORT and the other medicine.
Danish: Hvis De bruger GANFORT sammen med anden øjenmedicin, skal der gå mindst 5 minutter mellem, at De påfører GANFORT og den anden medicin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS (PROVIDED IN 9 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE INDEHOLDENDE 90 ENKELTDOSISBEHOLDERE (LEVERET I 9 POSER, SOM HVER INDEHOLDER 10 ENKELTDOSISBEHOLDERE)
English: Plasma bimatoprost and timolol concentrations were determined in a crossover study comparing the monotherapy treatments to GANFORT (multi-dose formulation) treatment in healthy subjects.
Danish: Plasmakoncentrationer af bimatoprost og timolol blev bestemt i et crossover-studie med sammenligning af monoterapibehandling og GANFORT-behandling (flerdosisformulering) hos raske forsøgspersoner.
English: The majority of adverse reactions reported with GANFORT single-dose were ocular, mild in severity and none were serious.
Danish: De fleste bivirkninger, der er rapporteret med GANFORT enkeltdosis, var okulære og af lettere grad, og ingen var alvorlige.
English: Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid or periocular skin and increased brown iris pigmentation since these have been observed during treatment with bimatoprost and GANFORT.
Danish: Før behandlingen påbegyndes, skal patienten oplyses om risikoen for vækst af øjenvipper, mørkfarvning af øjenlågshuden eller huden omkring øjnene og øget brun irispigmentering, eftersom dette har været observeret ved behandling med bimatoprost og GANFORT.
English: A topical overdose with GANFORT single-dose is not likely to occur or to be associated with toxicity.
Danish: Det er ikke sandsynligt, at der vil forekomme lokal overdosering med GANFORT enkeltdosis, eller at dette vil være forbundet med toksicitet.
English: 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 kardiovaskulære sygdomme (f.eks. koronar hjertesygdom, Printzmetals angina og hjertesvigt) skal den hypotensive behandling med betablokkere vurderes kritisk, og behandling med andre stoffer bør overvejes.
English: • The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol maleate 6.8 mg/ml.
Danish: • Aktive stoffer: Bimatoprost 0,3 mg/ml og timolol 5 mg/ml svarende til timololmaleat 6,8 mg/ml.
English: GANFORT single-dose has not been studied in patients with hepatic or renal impairment.
Danish: GANFORT enkeltdosis er ikke undersøgt hos patienter med nedsat lever- eller nyrefunktion.
English: Carton containing 30 or 90 single-dose containers in three or nine aluminium foil pouches respectively.
Danish: Æske med 30 eller 90 enkeltdosisbeholdere i henholdsvis tre eller ni aluminiumfolieposer.
English: Based on this outcome, removal of the note in the SmPC in section 4.8 linking the ADR ‘Superior sulcus deepening' to only products containing preservative is recommended.
Danish: 4.8, der kun forbinder lægemiddelbivirkningen "fordybning af øvre sulcus" med produkter, der indeholder konserveringsmiddel.
English: Macular oedema, including cystoid macular oedema, has been reported with GANFORT.
Danish: Makulaødem, herunder cystoidt makulaødem, er forekommet med GANFORT.
English: GANFORT single-dose 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: GANFORT enkeltdosis bør anvendes med forsigtighed til patienter med let/moderat kronisk obstruktiv lungesygdom (KOL), og kun hvis den potentielle fordel opvejer den potentielle risiko.
English: Patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and receiving hypotension therapy with beta-blockers should be critically assessed and therapy with other active substances should be considered.
Danish: Hos patienter med kardiovaskulære sygdomme (f.eks. koronar hjertesygdom, Printzmetals angina og hjertesvigt), der får hypotensiv behandling med betablokkere, skal vurderes kritisk, og behandling med andre stoffer bør overvejes.
English: Keep single-dose containers in the pouch in order to protect from light and moisture.
Danish: Opbevar enkeltdosisbeholderne i posen for at beskytte dem mod lys og fugt.
English: Affecting other parts of the body difficulty breathing / wheezing, symptoms of allergic reaction (swelling, redness of the eye and rash of the skin), changes in your taste sensation, slowing of heart rate, difficulty sleeping, nightmare, asthma, hair loss, tiredness.
Danish: Vejrtrækningsbesvær/hvæsende vejrtrækning, symptomer på allergisk reaktion (hævelse, rødme af øjet og hudkløe), ændringer i smagssansen, nedsættelse af hjertefrekvensen, søvnbesvær, mareridt, astma, hårtab, træthed.
English: Allergan n.v. Tél/Tel: +32 (0)2 351 24 24
Danish: Tél/Tel: +32 (0)2 351 24 24
English: GANFORT single-dose has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure, congenital or narrow-angle glaucoma.
Danish: GANFORT enkeltdosis har ikke været undersøgt hos patienter med inflammatoriske øjenlidelser, neovaskulær, inflammatorisk, lukketvinklet, kongenit eller snævervinklet glaukom.
English: Beta-blockers are excreted in breast milk.
Danish: Betablokkere udskilles i human mælk.
English: No new adverse reactions specific for GANFORT single-dose have been observed in clinical studies.
Danish: Der er ikke observeret nye bivirkninger specifikt for GANFORT enkeltdosis i kliniske studier.
English: Carton containing 5 single-dose containers in an aluminium foil pouch.
Danish: Æske med 5 enkeltdosisbeholdere i en aluminiumfoliepose.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS (PROVIDED IN 3 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE INDEHOLDENDE 30 ENKELTDOSISBEHOLDERE (LEVERET I 3 POSER, SOM HVER INDEHOLDER 10 ENKELTDOSISBEHOLDERE)
English: GANFORT consists of two active substances: bimatoprost and timolol.
Danish: GANFORT indeholder to aktive stoffer: bimatoprost og timolol.
English: Always use GANFORT single-dose exactly as your doctor or pharmacist has told you.
Danish: Brug altid GANFORT enkeltdosis nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes.
Danish: Når De har dryppet øjne, bør der gå mindst 15 minutter, før De sætter linserne i igen.
English: GANFORT has not been studied in patients with hepatic or renal impairment.
Danish: GANFORT er ikke undersøgt hos patienter med nedsat lever- eller nyrefunktion.
English: If you forget to use GANFORT single-dose
Danish: Hvis De har glemt at bruge GANFORT enkeltdosis
English: Clear, single-dose low density polyethylene (LDPE) containers with a twist-off tab.
Danish: Gennemsigtige enkeltdosisbeholdere af lavdensitetspolyethylen (LDPE) med flig til afvridning.
English: Contents of the pack and other information What GANFORT single-dose contains
Danish: Pakningsstørrelser og yderligere oplysninger GANFORT enkeltdosis indeholder:
English: Therefore, GANFORT should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
Danish: GANFORT bør derfor anvendes med forsigtighed til afakiske patienter, pseudoafakiske patienter med rift i bageste linsekapsel eller patienter med kendt risiko for makulaødem (f.eks. intraokulær kirurgi, retinal veneokklusion, inflammatorisk øjensygdom og diabetisk retinopati).
English: GANFORT single-dose consists of two active substances: bimatoprost and timolol.
Danish: GANFORT enkeltdosis indeholder to aktive stoffer: bimatoprost og timolol.
English: Sodium phosphate dibasic heptahydrate Citric acid monohydrate
Danish: Dinatriumphosphatheptahydrat Citronsyremonohydrat
English: • Heart failure; irregularity or stopping of the heartbeat; slow or fast heartbeat; too much fluid,
Danish: • Hjertesvigt, uregelmæssig eller standset puls, langsom eller hurtig hjerterytme, ophobning af for meget væske, hovedsageligt vand, i kroppen, brystsmerter
English: Tell your doctor before surgical anaesthesia that you are using GANFORT single-dose as timolol may change effects of some medicines used during anaesthesia.
Danish: Fortæl Deres læge, at De bruger GANFORT enkeltdosis, inden De bedøves før en operation, da timolol kan ændre virkningen af noget af den medicin, der anvendes til bedøvelse.
English: Surgical anaesthesia β-blocking ophthalmological preparations may block systemic β-agonist effects e.g. of adrenaline.
Danish: Kirurgisk anæstesi β-blokerende oftalmologiske præparater kan eksempelvis blokere adrenalinets systemiske βagonistiske virkninger.
English: Colourless to slightly yellow solution.
Danish: En farveløs til lysegul opløsning.
English: Tell your doctor before surgical anaesthesia that you are using GANFORT as timolol may change effects of some medicines used during anaesthesia.
Danish: Fortæl Deres læge, at De bruger GANFORT, inden De bedøves før en operation, da timolol kan ændre virkningen af noget af den medicin, der anvendes til bedøvelse.
English: After twice daily dosing, the mean AUC 0-24hrs value of 0.0634 ng•hr/ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 ng•hr/ml in young healthy adults.
Danish: Efter 1 dosis 2 gange om dagen var AUC 0-24t middelværdien af 0,0634 ng•time/ml bimatoprost hos ældre (forsøgspersoner over 65 år) signifikant højere end 0,0218 ng•time/ml hos unge, raske voksne.
English: If you stop using GANFORT single-dose
Danish: Hvis De holder op med at bruge GANFORT enkeltdosis
English: After twice daily dosing of bimatoprost 0.3 mg/ml, the mean AUC 0-24hrs value of 0.0634 ng•hr/ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 ng•hr/ml in young healthy adults.
Danish: Efter 1 dosis a bimatoprost 0,3 mg/ml 2 gange om dagen var AUC 0-24t middelværdien af 0,0634 ng•time/ml bimatoprost hos ældre (forsøgspersoner over 65 år) signifikant højere end 0,0218 ng•time/ml hos unge, raske voksne.
English: Affecting other parts of the body runny nose, dizziness, headache.
Danish: Påvirkning af andre dele af kroppen løbenæse, svimmelhed, hovedpine.
English: Therefore, GANFORT single-dose should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
Danish: GANFORT enkeltdosis bør derfor anvendes med forsigtighed til afakiske patienter, pseudoafakiske patienter med rift i bageste linsekapsel eller patienter med kendt risiko for makulaødem (f.eks. intraokulær kirurgi, retinal veneokklusion, inflammatorisk øjensygdom og diabetisk retinopati).
English: Wipe off any excess that runs down the cheek.
Danish: Tør eventuelt overskydende øjendråber, som løber ned ad kinden, væk.
English: Surgical anaesthesia
Danish: Kirurgisk anæstesi
English: If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart.
Danish: Hvis flere lokalt virkende øjenlægemidler anvendes, bør inddrypning med dem ske med mindst 5 minutters mellemrum.
English: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline.
Danish: Beta-blokerende oftalmologiske præparater kan eksempelvis blokere adrenalinets systemiske betaagonistiske virkninger.
English: 1 adverse reactions observed with Timolol 2 adverse reactions observed with Bimatoprost
Danish: 1 bivirkninger, der er set med timolol 2 bivirkninger, der er set med bimatoprost
English: Benzalkonium chloride
Danish: Benzalkoniumchlorid Natriumchlorid
English: Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.
Danish: Der er rapporteret om koroidalløsning ved administration af lægemidler, der reducerer produktion af kammervand (f.eks. timolol, acetazolamid) efter trabekulektomi.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FLASKEN
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SINGLE-DOSE CONTAINER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ENKELTDOSISBEHOLDER
English: Turn the single-dose container upside down and squeeze it to release 1 drop into the affected eye(s).
Danish: Vend bunden i vejret på enkeltdosisbeholderen og klem den, så der dryppes 1 dråbe i det/de berørte øje/øjne.
English: GANFORT has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Danish: GANFORT har ikke været undersøgt hos patienter med inflammatoriske øjenlidelser, neovaskulær, inflammatorisk, lukketvinklet glaukom, kongenit eller snævervinklet glaukom.
English: As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.
Danish: Ligesom med enhver topisk øjenbehandling skal patienten, hvis synet bliver sløret efter administration, vente med at køre bil eller betjene maskiner, til synet er klart igen.
English: Each ml of solution contains 0.05 mg of benzalkonium chloride.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver ml opløsning indeholder 0,05 mg benzalkoniumchlorid.
English: Do not use GANFORT single-dose after the expiry date which is stated on the single-dose container and the carton.
Danish: Brug ikke GANFORT enkeltdosis efter den udløbsdato, der står på pakningen.
English: Do not use GANFORT single-dose if you are breast-feeding.
Danish: Brug ikke GANFORT enkeltdosis, hvis De ammer.
English: Existing literature data for GANFORT suggest that evening dosing may be more effective in IOP lowering than morning dosing.
Danish: Data fra den eksisterende litteratur om GANFORT tyder på, at aftendosering kan være mere effektivt til sænkning af IOP end morgendosering.