FrancophonIA/ELRC3.0 huggingface dataset:
English: Discard four weeks after first opening.
Danish: Kasseres fire uger efter åbning.
English: Table 1 System Organ Class
Danish: Tabel 1 Systemorganklasse
English: Therefore monitoring is required with frequent or prolonged use of GANFORT in dry eye patients or where the cornea is compromised.
Danish: Der kræves derfor tæt opfølgning ved hyppig eller langvarig brug af GANFORT hos patienter med tørre øjne eller ved tilfælde, hvor cornea er kompromitteret.
English: Therefore in view of the data presented in the reviewed PSUR, the PRAC considers that changes to the product information of medical products containing timolol were warranted.
Danish: Set i lyset af de data, der præsenteres i den reviderede PSUR, mener PRAC derfor, at ændringer i produktinformationen for lægemidler, der indeholder timolol, er berettigede.
English: Table 2 System Organ Class
Danish: Tabel 2 Systemorganklasse
English: Taking into account the PRAC Assessment Report on the PSUR(s) for bimatoprost / timolol, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC'S vurderingsrapport om PSUR'en/PSUR'erne for bimatoprost/timolol er CHMP nået frem til følgende videnskabelige konklusioner:
English: Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP at all follow up timepoints throughout the study (p < 0.001).
Danish: Begge behandlingsgrupper viste statistisk og klinisk signifikante middelfald fra baseline i det dårligste øjes IOP på alle kontroltidspunkter gennem hele studiet (p < 0,001).
English: Let go of the lower lid, and close your eye.
Danish: Slip det nederste øjenlåg, og luk øjet.
English: 2017;26(9):e214-e216, four strong cases of hallucinations with ophthalmic timolol (single-substance) were reported, all in elderly patients with coexisting CNS pathology.
Danish: 2017;26(9):e214-e216 rapporterede om fire stærke tilfælde af hallucinationer med oftalmisk timolol (enkeltstof), alle hos ældre patienter med samtidigt eksisterende CNS-patologi.
English: This dose expressed as mg/m2 is at least 70-times higher than the accidental dose of one bottle of GANFORT in a 10 kg child.
Danish: Denne dosis udtrykt i mg/m2 er mindst 70 gange højere end den ved et uheld indtaget dosis af 1 flaske GANFORT hos et barn, der vejer 10 kg.
English: No adequate clinical data in exposed pregnancies are available.
Danish: Der foreligger ikke tilstrækkelige kliniske data om eksponering under graviditet.
English: The anaesthesiologist should be informed when the patient is receiving timolol.
Danish: Anæstesiologen skal underrettes i tilfælde af, at patienten får timolol.
English: It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat.
Danish: Det vides ikke, om bimatoprost udskilles i human mælk, men stoffet udskilles i rottemælk.
English: In conclusion, there is evidence to suggest that ophthalmic timolol can be associated with hallucinations, either through systemic effects or through CNS penetration of timolol.
Danish: Det konkluderes, at der er beviser, der tyder på, at oftalmologisk timolol kan forbindes med hallucinationer, enten ved systemiske virkninger eller ved timolols CNS-penetration.
English: • Severe allergic reactions with swelling and difficulty breathing which could be life-threatening
Danish: • Alvorlige allergiske reaktioner med hævelse og åndenød, der kan være livstruende
English: You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
Danish: De må ikke anvende flasken, hvis plomberingen på flaskehalsen er brudt, før De begynder at anvende flasken.
English: This helps to stop GANFORT getting into the rest of the body.
Danish: Dette er med til at forhindre, at GANFORT kommer ud i resten af kroppen.
English: Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces.
Danish: Bimatoprost elimineres primært ved udskillelse gennem nyrerne, og op til 67 % af en intravenøs dosis administreret til raske frivillige forsøgspersoner blev udskilt i urinen, mens 25 % af dosen blev udskilt via fæces.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}
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 de terapeutiske doser timolol i øjendråber er det imidlertid ikke sandsynligt, at der vil være tilstrækkelige mængder til stede i mælken til at fremkalde kliniske symptomer på betablokade hos spædbarnet.
English: A total of 56 cases have been derived from EudraVigilance for ophthalmic timolol products including 5 for the bimatoprost/timolol combination product which have given rise to various “Perception disturbances” like: Hallucination; Derealisation; Hallucination, auditory; Hallucination, visual.
Danish: I alt 56 tilfælde er blevet udledt af EudraVigilance for oftalmologiske timolol-produkter, herunder 5 for bimatoprost/timolol-kombinationsproduktet, der har givet anledning til forskellige "opfattelsesforstyrrelser" som f.eks.: hallucination; derealisation; hallucination, auditiv; hallucination, visuel.
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 perifere kredsløbsforstyrrelser/sygdomme (dvs. alvorlige former for Raynauds sygdom eller Raynauds fænomener) bør behandles med forsigtighed.
English: The single-dose container is for single use only; one container is sufficient to treat both eyes.
Danish: Enkeltdosisbeholderen er kun til engangsbrug; en beholder er tilstrækkeligt til behandling af begge øjne.
English: Not known fatigue
Danish: Ikke kendt træthed
English: However, consideration should be given to the likelihood of compliance when considering either morning or evening dosing.
Danish: Der skal dog tages hensyn til sandsynligheden for komplians, når enten morgen- eller aftendosering overvejes.
English: Make sure that the single-dose container is intact before use.
Danish: Kontrollér, at enkeltdosisbeholderen er intakt før brug.
English: Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left.
Danish: Derfor skal flasken kasseres 4 uger efter første åbning, selv om der stadig er lidt af opløsningen tilbage.
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, når det når frem til den systemiske cirkulation efter okulær administration.
English: Insomnia2, nightmare2
Danish: Ikke kendt søvnløshed2, mareridt2
English: If the liquid cannot drain out quickly enough, the pressure inside the eye builds up and could eventually damage your sight (an illness called glaucoma).
Danish: Såfremt væsken ikke kan løbe hurtigt nok ud, stiger trykket i øjet, og til sidst vil den kunne beskadige synet (en sygdom, der kaldes glaukom eller grøn stær).
English: Beta-blockers may also mask the signs of hyperthyroidism.
Danish: Betablokkere kan også maskere tegn på hyperthyroidisme.
English: After ocular administration, the systemic exposure of bimatoprost is very low with no accumulation over time.
Danish: Efter okulær administration er den systemiske eksponering for bimatoprost meget lav og uden akkumulering over tiden.
English: Once opened, solutions may become contaminated, which can cause eye infections.
Danish: Efter åbning af flasken kan opløsningen blive forurenet, hvilket kan give øjeninfektioner.
English: The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
Danish: Pigmenteringsforandringen skyldes øget melaninindhold i melanocytterne snarere end et øget antal melanocytter.
English: This ADR is most likely linked to the active substance bimatoprost, and not the preservative.
Danish: Denne lægemiddelbivirkning er mest sandsynligt forbundet med det aktive stof bimatoprost og ikke konserveringsmidlet.
English: Studies in rodents produced species-specific abortion at systemic exposure levels 33- to 97-times that achieved in humans after ocular administration.
Danish: Studier med gnavere frembragte artsspecifik abort ved systemisk eksponering, som var 33 til 97 gange højere end den opnåede humane eksponering efter okulær administration.
English: The chance of having side effects after using eye drops is lower than when medicines are for example, taken by mouth or injected.
Danish: Sandsynligheden for at få bivirkninger efter anvendelse af øjendråber er lavere end, når medicin for eksempel tages gennem munden eller indsprøjtes.
English: This medicine is for single use only and does not contain preservatives.
Danish: Dette lægemiddel er kun til engangsbrug og indeholder ingen konserveringsmidler.
English: On the basis of the scientific conclusions for bimatoprost / timolol the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing bimatoprost / timolol is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for bimatoprost/timolol er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder bimatoprost/timolol, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: These may affect more than 1 user in 10 Affecting the eye redness.
Danish: Disse kan påvirke flere end 1 bruger af 10 Påvirkning af øjet rødme.
English: Based on this outcome, update of section 4.8 of the Summary of Product Characteristic to add ‘hallucination' with the frequency ‘not known' is recommended.
Danish: 4.8 i produktresumeet for at tilføje "hallucinationer" med hyppigheden "ikke kendt".
English: A study of patients with renal failure showed that timolol did not dialyse readily.
Danish: Et studie med patienter med nyresvigt viste, at timolol ikke fjernes hurtigt ved dialyse.
English: Do not stop using Ganfort without speaking to your doctor.
Danish: De må ikke holde op med at bruge GANFORT uden at tale med lægen.
English: Tear 1 single-dose container from the strip.
Danish: Riv 1 enkeltdosisbeholder af strippen.
English: No enhancement of the systemic absorption of the individual active substances has been observed.
Danish: Der er ikke observeret forstærket systemisk absorption af de enkelte aktive indholdsstoffer.
English: Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Danish: Benzalkoniumchlorid er blevet rapporteret at forårsage punktformet keratopati og/eller toksisk ulcerøs keratopati.
English: These may affect 1 to 9 users in 100
Danish: Disse kan påvirke 1 til 9 brugere af 100
English: To help you remember, write down the date that you opened it in the space on the carton.
Danish: For at huske datoen for første åbning bør De skrive denne dato ned i feltet på æsken.
English: Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 1/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 dernæst oxydering, N-deethylering og glucuronisering, hvorved der dannes en række forskellige metabolitter.
English: • Depression; memory loss; hallucination
Danish: • Depression, hukommelsestab, hallucination
English: The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 1/hr/kg.
Danish: Eliminationshalveringstiden, bestemt efter intravenøs administration, var ca. 45 minutter, og den totale blod-clearance var 1,5 l/time/kg.
English: To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else.
Danish: For at undgå forurening må den åbne ende af endosisbeholderen ikke berøre Deres øje eller noget andet.
English: Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pace-maker.
Danish: - Sinus bradykardi, syg sinus-syndrom, sinoatrialt blok, 2. eller 3. grads atrioventrikulært blok, som ikke er kontrolleret med pacemaker.
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 administration.
English: The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.5).
Danish: Anvendelse af to beta-adrenerge blokkere til lokal brug anbefales ikke (se pkt.
English: EU/1/06/340/003 5 single-dose containers EU/1/06/340/004 30 single-dose containers EU/1/06/340/005 90 single-dose containers
Danish: EU/1/06/340/003 5 enkeltdosisbeholdere EU/1/06/340/004 30 enkeltdosisbeholdere EU/1/06/340/005 90 enkeltdosisbeholdere
English: Whilst keeping the eye closed, press your finger against the corner of the closed eye (the site where the eye meets the nose) and hold for 2 minutes.
Danish: Hold øjet lukket, tryk fingeren mod øjenkrogen på det lukkede øje (der, hvor øjet møder næsen) og hold i 2 minutter.
English: Clinical effects
Danish: Klinisk virkning
English: Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
Danish: Vend bunden i vejret på flasken og klem den, så der dryppes en dråbe i hvert øje, der skal behandles.
English: Like all medicines, GANFORT can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Overt cardiac failure, cardiogenic shock.
Danish: Signifikant hjertesvigt, kardiogent shock.
English: After discontinuation of GANFORT, pigmentation of iris may be permanent.
Danish: Efter seponering af GANFORT kan irispigmenteringen være permanent.
English: Use at the same time each day.
Danish: Dryp øjet/øjnene på samme tidspunkt hver dag.
English: Remove contact lenses before use.
Danish: Tag kontaktlinser ud før brug.
English: There is a potential for hair growth to occur in areas where GANFORT solution comes repeatedly in contact with the skin surface.
Danish: Der er risiko for hårvækst i områder, hvor GANFORT-øjendråberne gentagne gange kommer i kontakt med hudens overflade.
English: Part of the dose is absorbed systemically where it is extensively metabolised in the liver.
Danish: En del af dosis absorberes systemisk og metaboliseres derefter i udstrakt grad i leveren.
English: Opened:
Danish: Åbning:
English: Other side effects reported with eye drops containing phosphates In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Danish: Andre indberettede bivirkninger med øjendråber, der indeholder phosphater I meget sjældne tilfælde har nogle patienter med alvorlige skader på den forreste klare del af øjet (hornhinden) udviklet uklare pletter på hornhinden, som skyldes dannelse af kalk i løbet af behandlingen.
English: Like other medicines applied into eyes, timolol is absorbed into the blood.
Danish: Ligesom andre lægemidler, der kommes i øjet, optages timolol i blodet.
English: Mean changes from baseline worse eye IOP ranged from -9.16 to -7.98 mm Hg for GANFORT (single-dose) group, and from -9.03 to -7.72 mm Hg for the GANFORT (multi-dose formulation) group across the 12-week study.
Danish: Middelændringer fra baseline i det dårligste øjes IOP lå mellem -9,16 og -7,98 mmHg for GANFORT (enkeltdosis)-gruppen og mellem -9,03 og -7,72 mmHg for GANFORT (flerdosisformulering)-gruppen over 12-ugers studiet.
English: The mechanism of action by which bimatoprost reduces intraocular pressure in man 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, består i at øge kammervandsafløbet gennem trabekelværket og øge det uveosclerale afløb.
English: GANFORT should not be used during pregnancy unless clearly necessary.
Danish: GANFORT bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
English: The preservative in GANFORT, benzalkonium chloride, may cause eye irritation.
Danish: Konserveringsmidlet i GANFORT, benzalkoniumchlorid, kan forårsage øjenirritation.
English: After 12 months treatment with bimatoprost eye drops alone, the incidence was 1.5% and did not increase following 3 years treatment.
Danish: Efter 12 måneders behandling med bimatoprost øjendråber alene var incidensen 1,5 %, og den steg ikke efter 3 års behandling.
English: These may affect 1 to 9 users in 1,000
Danish: Disse kan påvirke 1 til 9 brugere af 1000
English: No enhancement of the systemic absorption of the individual active substances has been observed with GANFORT (multi-dose formulation).
Danish: Der er ikke observeret forstærket systemisk absorption af de enkelte aktive indholdsstoffer med GANFORT (flerdosisformulering).
English: There are no adequate data from the use of the bimatoprost / timolol fixed combination in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af bimatoprost/timolol i fast kombinationsforhold til gravide kvinder.
English: Immune system disorders systemic allergic reactions including anaphylaxis1
Danish: Immunsystemet systemiske allergiske reaktioner, herunder anafylaksi1
English: This may cause similar side effects as seen with ”intravenous” and /or “oral” beta-blocking agents.
Danish: Det kan give bivirkninger, der ligner dem, der ses med ”intravenøse” og/eller “orale” betablokkere.
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 drug 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 lægemiddelkoncentration blev nået i løbet af den første uges okulære administration.
English: GANFORT single-dose achieved noninferior IOP-lowering efficacy to GANFORT (multi-dose formulation): the upper limit of the 95% CI of the between-treatment difference was within the pre-defined 1.5 mm Hg margin at each timepoint evaluated (hours 0, 2, and 8) at week 12 (for the primary analysis), and also at weeks 2 and 6, for mean worse eye IOP change from baseline (worse eye IOP refers to the eye with the higher mean diurnal IOP at baseline).
Danish: GANFORT enkeltdosis opnåede ikke-inferiør IOP-sænkende effekt i forhold til GANFORT (flerdosisformulering): Den øvre grænse af 95 %-konfidensintervallet for forskellen mellem de 2 behandlinger lå inden for den foruddefinerede margen på 1,5 mmHg på alle evaluerede tidspunkter (0, 2 og 8 timer) ved uge 12 (for den primære analyse) og også ved uge 2 og 6 for ændring fra baseline i det dårligste øjes IOP (det dårligste øjes IOP henviser til øjet med den højeste gennemsnitlige døgn-IOP ved baseline).
English: GANFORT is a colourless to slightly yellow, clear eye drop solution in a plastic bottle.
Danish: GANFORT er øjendråber i form af en farveløs til svagt gul, klar opløsning i en plastflaske.
English: These doses are at least 7.5 times higher than the amount of bimatoprost in an accidental dose of the entire contents of a carton of GANFORT single-dose (90 single-dose containers x 0.4 mL; 36 mL) in a 10 kg child [(36 mL*0.3 mg/mL bimatoprost)/10 kg; 1.08 mg/kg].
Danish: Disse doser er mindst 7,5 gange højere end mængden af bimatoprost i en dosis på hele indholdet af en æske GANFORT enkeltdosis (90 enkeltdosisbeholdere x 0,4 ml; 36 ml) indtaget ved et uheld af et barn, der vejer 10 kg [(36 ml*0,3 mg/ml bimatoprost)/10 kg; 1,08 mg/kg].
English: Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years.
Danish: Den farveændring af iris, som ses ved administration af bimatoprost-øjendråber, er ikke nødvendigvis registrerbar de første mange måneder eller år.
English: The precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP synthesis caused by endogenous beta-adrenergic stimulation is probable.
Danish: Den nøjagtige virkningsmekanisme er ikke helt afklaret, men beror sandsynligvis på hæmning af den øgede cAMPsyntese, som skyldes endogen beta-adrenerg stimulation.
English: Listed side effects include reactions seen within bimatoprost and timolol when used for treating eye conditions:
Danish: De kendte bivirkninger omfatter reaktioner, der ses inden for bimatoprost og timolol, når de anvendes til behandling af øjenlidelser:
English: If GANFORT is administered until delivery, the neonate should be carefully monitored during the first days of life.
Danish: Hvis GANFORT administreres frem til fødslen, skal den nyfødte overvåges nøje i løbet af de første levedage.
English: If you forget to use GANFORT, use a single drop as soon as you remember, and then go back to your regular routine.
Danish: Hvis De glemmer at bruge GANFORT, inddryppes en enkelt dråbe, så snart De husker det. Fortsæt derefter den normale rutine.
English: Not known hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy
Danish: Ikke kendt overfølsomhedsreaktioner, inklusive tegn eller symptomer på allergisk dermatitis, angioødem, øjenallergi
English: Once the container is removed from the pouch use within 7 days.
Danish: Når beholderen er fjernet fra posen, skal den bruges inden for 7 dage.
English: GANFORT single-dose is a colourless to slightly yellow solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.
Danish: GANFORT enkeltdosis er en farveløs til svagt gul opløsning, der leveres i enkeltdosisbeholdere af plastic, som hver indeholder 0,4 ml.
English: To reduce the systemic absorption, see section 4.2.
Danish: 4.2 vedrørende reduktion af den systemiske absorption.
English: Dysgeusia2
Danish: Ikke kendt dysgeusi2
English: GANFORT should be used with caution in patients with active intraocular inflammation (e.g. uveitis) because the inflammation may be exacerbated.
Danish: GANFORT bør anvendes med forsigtighed til patienter med aktiv intraokulær inflammation (f.eks. uveitis), da inflammationen kan forværres.
English: Timolol belongs to a group of medicines called beta-blockers.
Danish: Timolol tilhører en gruppe lægemidler, der kaldes betablokkere.
English: Increased iris pigmentation is likely to be permanent, and may lead to differences in appearance between the eyes if only one eye is treated.
Danish: Det er sandsynligt, at den øgede irispigmentering vil være permanent og kan medføre til forskelle i øjnenes udseende, når kun det ene øje behandles.
English: GANFORT eye drops are used to treat high pressure in the eye in adults, including the elderly.
Danish: GANFORT øjendråber anvendes til behandling af forhøjet tryk i øjet hos voksne, inklusive ældre.
English: • Low blood pressure, high blood pressure, swelling or coldness of your hands, feet and extremities, caused by constriction of your blood vessels
Danish: • For lavt blodtryk, forhøjet blodtryk, hævede eller kolde hænder, fødder, arme eller ben som følge af forsnævring af blodkarrene
English: Ganfort contains a preservative called benzalkonium chloride.
Danish: GANFORT indeholder et konserveringsmiddel, der hedder benzalkoniumchlorid.