FrancophonIA/ELRC3.0 huggingface dataset:
English: Dysgeusia was the most common systemic adverse reaction associated with the use of SIMBRINZA (3.4%).
Danish: Dysgeusi var den hyppigst forekommende systemiske bivirkning forbundet med behandling med SIMBRINZA (3,4 %).
English: Do not use SIMBRINZA unless clearly indicated by your doctor.
Danish: Brug ikke SIMBRINZA, medmindre din læge har anbefalet det.
English: Hold the bottle, pointing down, between your thumb and fingers.
Danish: Hold flasken i hånden, med spidsen pegende nedad, mellem din tommelfinger og de andre fingre.
English: Brinzolamide was not teratogenic in rats and rabbits, following systemic administration (oral gavage).
Danish: Brinzolamid var ikke teratogent i rotter og kaniner, efter systemisk administration (oral dosering via sonde).
English: Studies to determine the effects of age, race, and renal or hepatic impairment have not been conducted with SIMBRINZA.
Danish: Studier til at fastslå virkningerne af alder, race og nedsat nyre-eller leverfunktion er ikke blevet udført med SIMBRINZA.
English: Whole blood elimination half-life is prolonged (>100 days) in humans due to RBC carbonic anhydrase binding.
Danish: Eliminationshalveringstiden i fuldblod er forlænget (>100 dage) hos mennesker som følge af RBC-karboanhydrasebindingen.
English: Not known: arthralgia
Danish: Ikke kendt: artralgi
English: Patients must be instructed to remove contact lens prior to application of SIMBRINZA and wait at least 15 minutes before reinsertion.
Danish: Patienter skal instrueres i at fjerne kontaktlinser, før applikation af SIMBRINZA og vente i mindst 15 minutter, før linserne sættes i igen.
English: Specifically, patients wearing contact lenses have not been studied and careful monitoring of these patients when using brinzolamide is recommended, since carbonic anhydrase inhibitors may affect corneal hydration and wearing contact lenses might increase the risk for the cornea (for further instructions on wearing contact lenses, see below under “Benzalkonium chloride”).
Danish: Patienter med kontaktlinser er ikke specifikt blevet undersøgt, og det anbefales, at disse patienter monitoreres omhyggeligt ved brug af brinzolamid, da karboanhydrasehæmmere kan påvirke væsketilførslen til cornea, og brug af kontaktlinser kan øge risikoen for cornea (se nedenfor under "Benzalkoniumchlorid" for yderligere instruktioner vedrørende brug af kontaktlinser).
English: 3, dysgeusia
Danish: 3, dysgeusi
English: Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne anført efter, hvor alvorlige de er.
English: In animal studies, brimonidine crossed the placenta and entered into the foetal circulation to a limited extent (see section 5.3).
Danish: Resultater fra dyrestudier indikerer, at brimonidin passerer placenta og går over i det føtale kredsløb i begrænset omfang (se afsnit 5.3).
English: 1, rhinorrhoea
Danish: 1, rhinorré
English: Brinzolamide and Ndesethylbrinzolamide do not inhibit cytochrome P450 isozymes at concentrations at least 100-fold above maximum systemic levels.
Danish: Brinzolamid og N-desethylbrinzolamid hæmmer ikke cytokrom P450-isozymer ved koncentrationer på mindst 100-gange over de maksimale systemiske niveauer.
English: Available pharmacodynamic/toxicological data in animals have shown that following oral administration, minimal levels of brinzolamide are excreted in breast milk.
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra studier i dyr viser, at brinzolamid udskilles i mælk i minimale mængder efter oral administration.
English: It is likely to be caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal and is mainly attributable to the brinzolamide component of SIMBRINZA.
Danish: Dysgeusi er sandsynligvis forårsaget af passage af øjendråberne til nasopharynx via den nasolakrimale kanal og skyldes hovedsagligt brinzolamid-komponenten i SIMBRINZA.
English: Hydrochloric acid and/or sodium hydroxide (to adjust pH) Purified water
Danish: Saltsyre og/eller natriumhydroxid (til justering af pH) Renset vand
English: SIMBRINZA is therefore contraindicated in children below 2 years of age (see section 4.3).
Danish: SIMBRINZA er derfor kontraindiceret hos børn under 2 år (se pkt.
English: Additionally, administration of brimonidine results in an increase in uveoscleral outflow.
Danish: Derudover medfører adminstration af brimonidin et øget uveoscleralt afløb.
English: Uncommon: vertigo
Danish: Ikke almindelig: vertigo
English: Due to the brinzolamide component of SIMBRINZA, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur.
Danish: Som følge af brinzolamid-komponenten i SIMBRINZA kan der forekomme forstyrrelse i elektrolytbalancen, udvikling af en acidotisk tilstand og mulig påvirkning af nervesystemet.
English: Although both brinzolamide and brimonidine lower IOP by suppressing aqueous humour formation, their mechanisms of action are different.
Danish: Selvom både brinzolamid og brimonidin sænker IOP ved at undertrykke dannelsen af kammervæske, er deres virkemekanismer forskellige.
English: Caution is advised due to the possibility of an additive or potentiating effect with CNS depressants (e.g. alcohol, barbiturates, opiates, sedatives or anaesthetics).
Danish: Forsigtighed tilrådes pga. muligheden for en additiv eller forstærkende effekt ved brug af CNSdepressiva (f.eks. alkohol, barbiturater, opiater, sedativer eller anæstetika).
English: 2, bradycardia
Danish: 2, bradykardi
English: Brinzolamide pharmacokinetics are inherently non-linear due to saturable binding to carbonic anhydrase in whole blood and various tissues.
Danish: Farmakokinetikken for brinzolamid er grundlæggende non-lineær på grund af den mættede binding til karboanhydrase i fuldblod og forskelligt væv.
English: Brimonidine is primarily eliminated in the urine as metabolites.
Danish: Brimonidin udskilles primært som metabolitter gennem urinen.
English: SIMBRINZA with alcohol
Danish: Brug af SIMBRINZA sammen med alkohol
English: Eye drops, suspension (eye drops).
Danish: Øjendråber, suspension (øjendråber).
English: The potential for interactions must be considered in patients receiving SIMBRINZA.
Danish: Risikoen for interaktioner skal overvejes hos patienter ved brug af SIMBRINZA.
English: White-to-off-white uniform suspension, pH 6.5 (approximately).
Danish: En hvid til råhvid ensartet suspension, pH ca. 6,5.
English: • General side effects: drowsiness, dizziness, bad taste in mouth, dry mouth
Danish: • Generelle bivirkninger: døsighed, svimmelhed, dårlig smag i munden, tør mund
English: Brimonidine is extensively metabolised by hepatic aldehyde oxidase, with formation of 2oxobrimonidine, 3-oxobrimonidine and 2,3-dioxobrimonidine being the major metabolites.
Danish: Brimonidin metaboliseres i udpræget grad af den hepatiske aldehyd-oxidase med dannelse af 2oxobrimonidin, 3-oxobrimonidin og 2,3-dioxobrimonidin, som er hovedmetabolitterne.
English: • Effects in the eye: decreased pupil size
Danish: • Reaktioner i øjet: reduceret pupilstørrelse
English: Adverse reactions commonly associated with the brimonidine component of SIMBRINZA include the development of ocular allergic type reactions, fatigue and/or drowsiness, and dry mouth.
Danish: Bivirkninger, der almindeligvis er forbundet med brimonidin-komponenten fra SIMBRINZA omfatter udvikling af okulære overfølsomhedsreaktioner, træthed og/eller døsighed og tør mund.
English: In rabbits oral, maternally toxic doses of brinzolamide of up to 6 mg/kg/day (261 times the recommended daily clinical dose of 23 µg/kg/day) revealed no effect on foetal development.
Danish: Hos kaniner havde orale, maternelle toksiske doser af brinzolamid på op til 6 mg/kg/dag (261 gange den daglige anbefalede kliniske dosis på 23 µg/kg/dag) ingen effekt på fosterudviklingen.
English: Each mL of suspension contains 0.03 mg of benzalkonium chloride.
Danish: Hver ml suspension indeholder 0,03 mg benzalkoniumchlorid.
English: Non-clinical data do not show any effects of brinzolamide or brimonidine on fertility.
Danish: Prækliniske data viser ingen effekt af brinzolamid eller brimonidin på fertiliteten.
English: Retention in ocular tissues is prolonged due to binding to carbonic anhydrase.
Danish: Retention i okulært væv er forlænget som følge af bindingen til karboanhydrase.
English: Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or a disorder of the cornea (the clear layer at the front of the eye).
Danish: Benzalkoniumchlorid kan også give øjenirritation, især hvis du har tørre øjne eller hornhinde problemer (det klare lag forrest i øjet).
English: Dose related decreases in foetal weights were observed in pups of dams given 2 to 18 mg/kg/day.
Danish: Dosisrelateret vægttab hos fostrene blev observeret hos hunnernes unger ved 2 til 18 mg/kg/dag.
English: If SIMBRINZA has been accidentally swallowed then you should contact your doctor immediately.
Danish: Hvis du ved et uheld er kommet til at sluge SIMBRINZA, skal du straks kontakte din læge.
English: Tricyclic antidepressants may blunt the ocular hypotensive response of SIMBRINZA.
Danish: Tricykliske antidepressiva kan sløre SIMBRINZAs okulære hypotensive respons.
English: Pull down your lower eyelid with a clean finger, until there is a ‘pocket' between the eyelid and your eye.
Danish: Træk det nedre øjenlåg nedad med en ren finger, indtil der dannes en sprække mellem øjenlåget og øjet.
English: SIMBRINZA has not been studied in patients with severe renal impairment (CrCl <30 mL/min) or in patients with hyperchloraemic acidosis.
Danish: SIMBRINZA er ikke undersøgt hos patienter med svær nedsat nyrefunktion (creatininclearance <30 ml/min) eller hos patienter med hyperkloræmisk acidose.
English: Uncommon: nasopharyngitis
Danish: Ikke almindelig: nasopharyngitis
English: Caution is advised when initiating (or changing the dose of) concomitant systemic medicinal products (irrespective of pharmaceutical form) which may interact with α-adrenergic agonists or interfere with their activity, i.e. agonists or antagonists of the adrenergic receptor (e.g. isoprenaline, prazosin).
Danish: Forsigtighed tilrådes ved indledende behandling (eller ændring af dosis) samtidigt med et systemisk lægemiddel (uanset dets farmaceutiske form), som kan interagere med α-adrenerge agonister eller interferere med deres aktivititet, dvs. agonister eller antagonister fra den adrenerge receptor (f.eks. isoprenalin, prazosin).
English: Difference Mean a
Danish: Difference Gennemsnit a
English: If a drop misses your eye, try again.
Danish: Hvis dråben ikke rammer øjet, prøv da igen med en ny dråbe.
English: 2, medication residue Not known: chest pain
Danish: 2, overskydende medicin Ikke kendt: brystsmerter
English: Manufacturer Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Spain
Danish: Fremstiller Alcon Cusí, S.A Camil Fabra 58 08320 El Masnou Spanien
English: SIMBRINZA should be used with caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis.
Danish: SIMBRINZA bør anvendes med forsigtighed til patienter med risiko for nedsat nyrefunktion, da der er risiko for metabolisk acidose.
English: Do not drive or use machines until the symptoms are cleared.
Danish: Du må ikke køre bil eller arbejde med maskiner, før dit syn er klart igen.
English: 3, miosis Not known: visual disturbances
Danish: 3, miose Ikke kendt: synsforstyrrelser
English: Continue with the next dose as planned.
Danish: Fortsæt efter den sædvanlige doseringsplan.
English: Wearing contact lenses - SIMBRINZA contains benzalkonium chloride
Danish: Brug af kontaktlinser - SIMBRINZA indeholder benzalkoniumchlorid
English: clomipramine, mianserin, venlafaxine and duloxetine - anaesthetics - sedatives, opiates, or barbiturates
Danish: nortriptylin, clomipramin, mianserin, venlafaxin og duloxetin - anæstetika - sedativer, opiater og barbiturater
English: It is expected that inhibitors of CYP3A4 such as ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of brinzolamide by CYP3A4.
Danish: Man kan forvente, at CYP3A4inhibitorer som ketokonazol, itrakonazol, clotrimazol, ritonavir og troleandomycin kan hæmme metaboliseringen af brinzolamid via CYP3A4.
English: SIMBRINZA may be used concomitantly with other topical ophthalmic medicinal products to lower intraocular pressure.
Danish: SIMBRINZA kan anvendes samtidig med andre topikale øjenpræparater til at sænke intraokulært tryk.
English: These findings were associated with metabolic acidosis with decreased body weight gain in dams and decreased foetal weights.
Danish: Disse fund var associeret til metabolisk acidose med nedsat kropsvægtøgning hos hunnerne og vægttab hos fostrene.
English: Eye drops, suspension
Danish: Øjendråber, suspension.
English: Adults who accidentally swallowed medicines containing brimonidine experienced a decreased heart rate, decreased blood pressure which may be followed by increased blood pressure, heart failure, difficulty breathing and effects in the nervous system.
Danish: Voksne, som ved et uheld kom til at indtage lægemidler med brimonidin, oplevede nedsat puls, blodtryksfald, som kan være efterfulgt af øget blodtryk, hjertesvigt, åndedrætsbesvær og påvirkninger af nervesystemet.
English: 8 mL round, opaque, low density polyethylene (LDPE) bottles with a LDPE dropper tip and white polypropylene screw cap (Drop-Tainer) containing 5 mL suspension.
Danish: 8 ml rund, uigennemsigtig flaske af polyethylen med lav densitet (LDPE), med dråbespids af LDPE og et hvidt skruelåg (Drop-Tainer) af polypropylen, der indeholder 5 ml suspension.
English: No data on the level of circulating catecholamines after SIMBRINZA administration are available.
Danish: Der findes ingen data om koncentrationen af cirkulerende catecholaminer efter administration af SIMBRINZA.
English: Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Danish: Undgå at berøre øjet eller øjenlåget, omgivende områder eller andre overflader med spidsen af flasken.
English: Studies in rabbits showed that maximum brinzolamide ocular concentrations following topical administration are in the anterior tissues such as cornea, conjunctiva, aqueous humour and iris-ciliary body.
Danish: Forsøg med kaniner viste, at de maksimale, okulære brinzolamid-koncentrationer efter topikal administration forekommer i det anteriore væv, såsom cornea, konjunktiva, kammervæsken og corpus ciliare.
English: No specific drug interaction studies have been performed with SIMBRINZA.
Danish: Der er ikke udført interaktionsstudier med SIMBRINZA.
English: Pharmacotherapeutic group: Ophthalmologicals, Antiglaucoma preparations and miotics, ATC code: S01EC54
Danish: Farmakoterapeutisk klassifikation: Oftalmologiske lægemidler, antiglaukommiddel og miotika, ATCkode: S01EC54
English: SIMBRINZA Mean a
Danish: SIMBRINZA Gennemsnit a
English: Uncommon: erectile dysfunction
Danish: Ikke almindelig: erektil dysfunktion
English: Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.
Danish: De gastrointestinale, centralnervesystemiske, hæmatologiske, renale og metaboliske virkninger er normalt associeret med brugen af systemiske karboanhydrasehæmmere.
English: Brimonidine administered orally is excreted in breast milk.
Danish: Oralt administreret brimonidin udskilles i human mælk.
English: Do not swallow or inject.
Danish: Det må ikke tages gennem munden eller indsprøjtes.
English: However, caution is advised in patients taking medicinal products which can affect the metabolism and uptake of circulating amines (e.g. chlorpromazine, methylphenidate, reserpine, serotoninnorepinephrine reuptake inhibitors).
Danish: Det anbefales imidlertid at udvise forsigtighed hos patienter, der tager lægemidler, som kan påvirke metabolismen og optagelsen af cirkulerende aminer (f.eks. klorpromazin og methylphenidat, reserpin, serotonin-noradrenalin-genoptagelseshæmmere).
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, optometrist (optician) or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, øjenlæge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Statistically superior reductions in the mean diurnal IOP were observed with SIMBRINZA compared to brinzolamide 10 mg/ml or brimonidine 2 mg/ml dosed twice daily at all visits throughout the study (Figure 1).
Danish: Der blev observeret statistisk overlegne reduktioner i den gennemsnitlige døgn-IOP med SIMBRINZA i forhold til med brinzolamid 10 mg/ml eller brimonidin 2 mg/ml, når det blev doseret to gange dagligt ved alle besøg i gennem hele studiet (figur 1).
English: The primary metabolite is N-desethylbrinzolamide, followed by the N-desmethoxypropyl and O-desmethyl metabolites, as well as an N-propionic acid analogue formed by oxidation of the N-propyl side chain of O-desmethyl brinzolamide.
Danish: Den primære metabolit er N-desethylbrinzolamid efterfulgt af N-desmethoxypropyl og O-desmethyl-metabolitterne samt N-propionsyreanalogen, som dannes ved oxidering af Npropylsidekæden til O-desmethyl-brinzolamid.
English: Hypersensitivity to sulphonamides (see section 4.4).
Danish: Overfølsomhed over for sulfonamider (se pkt.
English: , erythema
Danish: , erytem
English: If blurred vision occurs at instillation the patient must wait until the vision clears before driving or using machines.
Danish: Hvis der opstår sløret syn i forbindelse med drypning, skal patienten vente med at føre motorkøretøj og betjene maskiner, indtil synet er klart igen.
English: However, accumulation of brinzolamide is unlikely as renal elimination is the major route.
Danish: Akkumulering af brinzolamid er usandsynlig, da dette hovedsagelig udskilles renalt.
English: There is very limited information regarding accidental ingestion with the brimonidine component of SIMBRINZA in adults.
Danish: Der er meget begrænset information vedrørende utilsigtet indtagelse af brimonidin-komponenten fra SIMBRINZA i voksne.
English: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Danish: Midlertidigt sløret syn eller andre synsforstyrrelser kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: SIMBRINZA should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
Danish: SIMBRINZA skal anvendes med forsigtighed hos patienter med depression, cerebral- eller koronarinsufficiens, Raynauds syndrom, ortostatisk hypotension eller tromboangiitis obliterans.
English: Effects in non-clinical reproduction and development toxicity studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I prækliniske studier af reproduktions- og udviklingstoksicitet blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: • Severe skin reactions, including rash or redness or itching on your body or eyes
Danish: • Alvorlige hudreaktioner, som omfatter udslæt, rødme eller kløe på kroppen eller i øjnene
English: 2,abnormal sensation in eye
Danish: 2, unormal fornemmelse i øjet
English: Careful monitoring of patients with compromised corneas, such as patients with diabetes mellitus or corneal dystrophies, is recommended.
Danish: Det anbefales, at patienter med skadet cornea, herunder patienter med diabetes mellitus eller cornea-dystrofi, monitoreres omhyggeligt.
English: The following side effects have been observed with SIMBRINZA and other medicines containing brinzolamide or brimonidine alone.
Danish: Følgende bivirkninger er indberettet for SIMBRINZA og anden medicin, der indeholder brinzolamid eller brimonidin alene.
English: In rats doses of 18 mg/kg/day (783 times the recommended daily clinical dose), but not 6 mg/kg/day, resulted in slightly reduced ossification of skull and sternebrae of foetuses.
Danish: Hos rotter resulterede doser på 18 mg/kg/dag (783 gange den daglige anbefalede kliniske dosis), men ikke 6 mg/kg/dag, i en svagt nedsat ossifikation af kraniet og sternebrae på fostre.
English: • Effects in the eye: decreased growth of eyelashes
Danish: • Reaktioner i øjet: nedsat vækst af øjenvipper
English: The percentages of patients with an IOP measurement less than 18 mmHg were greater in the SIMBRINZA group than in the Brinzolamide group at 9 of 12 assessments through Month 6 and were greater in the SIMBRINZA group than in the Brimonidine group at all 12 assessments through Month 6.
Danish: Procentdelen af patienter med IOP-målinger på under 18 mmgHg var større i SIMBRINZA-gruppen end i Brinzolamid-gruppen på 9 ud af 12 evalueringer i måned 6, og var større i SIMBRINZA-gruppen end i Brimonidin-gruppen ved alle 12 evalueringer i måned 6.
English: 2, paraesthesia Very rare: syncope Not known: tremor
Danish: Meget sjælden: synkope Ikke kendt: tremor
English: Mean percent IOP reductions from baseline with SIMBRINZA ranged from 23 to 34%.
Danish: Gennemsnitlige IOP-reduktioner i procent i forhold til baseline med SIMBRINZA lå i området fra 23 til 34 %.
English: These two components lower intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT) by suppressing the formation of aqueous humour from the ciliary process in the eye.
Danish: Disse to komponenter sænker det intraokulære tryk (IOP) hos patienter med åbenvinklet glaukom (OAG) og okulær hypertension (OHT) ved at undertrykke dannelsen af kammervæske fra den ciliære proces i øjet.
English: Brinzolamide belongs to a group of medicines called carbonic anhydrase inhibitors and brimonidine tartrate belongs to a group of medicines called alpha-2 adrenergic receptor agonists.
Danish: Brinzolamid tilhører en gruppe af lægemidler, der kaldes karboanhydrasehæmmere, og brimonidintartrat en gruppe af lægemidler, der kaldes alfa-2-adrenerge receptoragonister.
English: Tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Danish: Små mængder saltsyre og/eller natriumhydroxid er tilsat for at bevare en normal surhedsgrad (pHværdi).
English: Caution is advised when using medicinal products such as antihypertensives and/or cardiac glycosides concomitantly with SIMBRINZA.
Danish: Forsigtighed tilrådes, når der anvendes lægemidler som antihypertensiva og/eller hjerteglykosider samtidig med SIMBRINZA.
English: SIMBRINZA is used to lower pressure in the eyes in adult patients (aged 18 years and over) who have eye conditions known as glaucoma or ocular hypertension and whose high pressure in the eyes cannot be controlled effectively by one medicine alone.
Danish: SIMBRINZA bruges til at sænke trykket i øjet hos voksne patienter (i alderen 18 år og derover), som har øjenlidelserne glaukom (grøn stær) eller forhøjet tryk i øjet, og hvor det høje tryk i øjet ikke kan bringes effektivt under kontrol med en medicin alene.
English: In a study of brinzolamide in subjects with renal impairment, a 1.6- to 2.8-fold increase in the systemic exposure to brinzolamide and N-desethylbrinzolamide between normal and moderately renally-impaired subjects was demonstrated.
Danish: I et forsøg med brinzolamid hos patienter med nyreinsufficiens, blev der påvist en 1,6- til 2,8 gange forøgelse i den systemiske eksponering over for brinzolamid og N-desethylbrinzolamid mellem patienter med normal og moderat nedsat nyrefunktion.
English: 2, blood chloride increased
Danish: 2, øget koncentration af chlorid i blodet
English: Uncommon: renal pain Not known: pollakiuria
Danish: Ikke almindelig: nyresmerter Ikke kendt: pollakisuri