FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of accidental ingestion, symptoms of overdose from beta blockade may include bradycardia, hypotension, cardiac failure and bronchospasm.
Danish: I tilfælde af utilsigtet indtagelse, kan symptomerne på overdosering fra beta-blokade omfatte bradykardi, hypotension, hjertesvigt og bronkospasme.
English: If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart.
Danish: Hvis der bruges mere end ét topikalt øjenlægemiddel, skal der gå mindst 5 minutter imellem administration af de forskellige lægemidler.
English: AZARGA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Danish: Azarga frarådes til børn og unge under 18 år på grund af utilstrækkelige data vedrørende sikkerhed og effekt.
English: There is limited experience with AZARGA in the treatment of patients with pseudoexfoliative glaucoma or pigmentary glaucoma.
Danish: Der er begrænset erfaring med Azarga til patienter med pseudoexfoliativ glaukom eller pigmentglaukom.
English: Keep the bottle tightly closed when not in use.
Danish: Flasken skal holdes tæt tillukket, når den ikke er i brug.
English: The combined effect of these two active substances results in additional IOP reduction compared to either compound alone.
Danish: Den kombinerede effekt af disse 2 aktive stoffer resulterer i en yderligere nedsættelse af det intraokulære tryk sammenlignet med det enkelte stofs effekt.
English: • tell your doctor before you have an operation that you are using AZARGA as timolol may change effects of some medicines used during anaesthesia.
Danish: • hvis du skal opereres, skal du fortælle lægen, at du bruger Azarga, idet timolol kan ændre virkningen af visse lægemidler, der bruges ved anæstesi (bedøvelse)
English: Ocular tissue distribution data in rabbits showed that timolol can be measured in aqueous humour up to 48 hours after administration of AZARGA.
Danish: Data vedrørende fordelingen af okulært væv i kaniner viste, at timolol kan måles i kammervæske op til 48 timer efter indgivelse af Azarga.
English: In 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 the therapy with other active substances should be considered.
Danish: Hos patienter med hjertekarsygdomme (f.eks. koronarsklerose, Prinzmetal angina og hjerteinsufficiens) og hypotension bør behandling med betablokkere vurderes omhyggeligt, og behandling med andre aktive stoffer bør overvejes.
English: Nasolacrimal occlusion or gently closing the eyelid after instillation may help reduce the occurrence of this effect (see section 4.2).
Danish: Nasolakrimal okklusion eller forsigtig lukning af øjnene efter drypning kan reducere forekomsten af denne bivirkning (se pkt.
English: If you forget to use AZARGA, continue with the next dose as planned.
Danish: Hvis du har glemt at bruge Azarga, skal du fortsætte med den sædvanlige doseringsplan.
English: The incidence of systemic adverse reactions after topical ophthalmic administration is lower than for systemic administration.
Danish: Forekomsten af systemiske bivirkninger efter topikal oftalmologisk administration er lavere end efter systemisk administration.
English: • Severe allergic rhinitis
Danish: • Svær allergisk rinit
English: Use in adults, including the elderly The dose is one drop of AZARGA in the conjunctival sac of the affected eye(s) twice daily.
Danish: Anvendelse til voksne inklusive ældre Dosis er 1 dråbe Azarga i konjunktivalsækken i det/de pågældende øje/øjne 2 gange dagligt.
English: This may lead to a corneal decompensation and oedema and wearing contact lenses might increase the risk for the cornea.
Danish: Dette kan medføre korneal dekompensation og ødem, og kontaktlinsebærere kan derfor have en øget risiko for skader på kornea.
English: Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents.
Danish: Betablokkere kan øge den hypoglykæmiske virkning af antidiabetika.
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: Det forventes, at CYP3A4-hæmmere som ketokonazol, itrakonazol, clotrimazol, ritonavir og troleandomycin kan hæmme metaboliseringen af brinzolamid via CYP3A4.
English: Timolol and its metabolites are primarily excreted by the kidneys.
Danish: Timolol og dens metabolitter udskilles hovedsageligt via nyrerne.
English: AZARGA 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: Azarga bør anvendes med forsigtighed hos patienter med let/moderat KOL, og kun hvis den potentielle fordel opvejer den potentielle risiko.
English: The metabolic pathways for the metabolism of brinzolamide involve N-dealkylation, O-dealkylation and oxidation of its N-propyl side chain.
Danish: Metaboliseringsveje for metaboliseringen af brinzolamid inkluderer N-dealkylation, O-dealkylation og oxydation af dets N-propyl-sidekæde.
English: • Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker.
Danish: • Sinusbradykardi, sygt sinussyndrom, herunder sino-atrialt blok, 2. eller 3. grads AV-blok, der ikke kontrolleres med pacemaker.
English: Warnings and precautions Only use AZARGA for dropping in your eye(s).
Danish: Advarsler og forsigtighedsregler Azarga må kun bruges til at dryppe i øjnene.
English: The concomitant administration of eye drops containing brinzolamide and oral carbonic anhydrase inhibitors is not recommended.
Danish: Samtidig administration af øjendråber, der indeholder brinzolamid og orale karboanhydrasehæmmere anbefales ikke.
English: Due to brinzolamide, electrolyte imbalance, development of an acidotic state, and possibly central nervous system effects may occur.
Danish: Elektrolyt ubalance, udvikling af en acidotisk tilstand og muligvis påvirkning af centralnervesystemet kan forekomme pga. brinzolamid.
English: AZARGA contains two active substances, brinzolamide and timolol, which work together to reduce pressure within the eye.
Danish: Azarga indeholder 2 aktive indholdsstoffer, brinzolamid og timolol, som arbejder sammen for at sænke trykket i øjet.
English: Overt cardiac failure, cardiogenic shock.
Danish: Åbenlyst hjerteinsufficiens, kardiogent shock.
English: If AZARGA is administered until delivery, the neonate should be carefully monitored during the first days of life.
Danish: Hvis Azarga anvendes frem til fødslen, skal det nyfødte barn overvåges nøje de første døgn efter fødslen.
English: Brinzolamide and N-desethyl-brinzolamide are the predominant components found in the urine along with trace levels (<1%) of the N-desmethoxypropyl and O-desmethyl metabolites.
Danish: Brinzolamid og N-desethyl-brinzolamid er de prædominante komponenter, der blev fundet i urinen sammen med mindre koncentrationer (<1 %) af N-desmethoxypropyl og O-desmethyl metabolitter.
English: At steady state, following administration of AZARGA, the mean plasma Cmax and AUC0-12h of timolol were 27% and 28% lower (Cmax: 0.824 ± 0.453 ng/ml; AUC0-12h: 4.71 ± 4.29 ng·h/ml), respectively, in comparison to the administration of timolol 5 mg/ml (Cmax: 1.13 ± 0.494 ng/ml; AUC0-12h: 6.58 ± 3.18 ng·h/ml).
Danish: Ved steady-state, efter indgivelse af Azarga, var det gennemsnitlige plasma Cmax og AUC0-12h for timolol henholdsvis 27 % og 28 % lavere (Cmax: 0,824 ± 0,453 ng/ml; AUC0-12h: 4,71 ± 4,29 ng h/ml) sammenlignet med indgivelse af timolol 5 mg/ml (Cmax: 1,13 ± 0,494 ng/ml; AUC012h: 6,58 ± 3,18 ng h/ml).
English: Studies in animals with brinzolamide have shown reproductive toxicity following systemic administration, see section 5.3.
Danish: Dyreforsøg med brinzolamid har påvist reproduktionstoksicitet efter systemisk administration(se pkt.
English: The non-inferiority of AZARGA as compared to dorzolamide 20 mg/ml + timolol 5 mg/ml in the mean IOP reduction was demonstrated across all time-points at all visits.
Danish: Der blev vist non-inferiority for Azarga sammenlignet med dorzolamid 20 mg/ml + timolol 5 mg/ml i den gennemsnitlige IOP-reduktion på alle tidspunkter ved alle besøg.
English: • General side effects: decrease in white blood cell count, decreased blood pressure, cough, blood in urine, body weakness.
Danish: • Øvrige bivirkninger: fald inedsat antal hvide blodlegemer, nedsat blodtryk, hoste, blod i urinen, svaghed i kroppen.
English: Epidemiological studies have not revealed malformative effects but show a risk for intra uterine growth retardation when beta-blockers are administered by the oral route.
Danish: Epidemiologiske studier har ikke vist forekomst af misdannelser, men der er påvist en risiko for intrauterin væksthæmning ved oral administration af betablokkere.
English: In three controlled clinical trials, the ocular discomfort upon instillation of AZARGA was significantly lower than that of dorzolamide 20 mg/ml + timolol 5 mg/ml.
Danish: I 3 kontrollerede kliniske forsøg var det okulære ubehag efter instillation af Azarga signifikant lavere end med dorzolamid 20 mg/ml + timolol 5 mg/ml.
English: 5 ml round opaque low density polyethylene bottles with a dispensing plug and white polypropylene screw cap (DROP-TAINER) containing 5 ml suspension.
Danish: 5 ml rund uigennemsigtig polyethylenflaske med lav densitet og med dråbespids og hvidt skruelåg (DROP-TAINER) af polypropylen, der indeholder 5 ml suspension.
English: Developmental toxicity studies in rabbits with oral doses of brinzolamide of up to 6 mg/kg/day (214 times the recommended daily clinical dose of 28 µg/kg/day) revealed no effect on foetal development despite significant maternal toxicity.
Danish: Toksiske udviklingsstudier med kaniner med oral dosering af brinzolamid på op til 6 mg/kg/dag (214 gange den anbefalede daglige kliniske dosis på 28/kg/dag) viste ingen effekt på foster-udvikling, trods signifikant maternal toksicitet.
English: No dosage adjustment is necessary in patients with hepatic impairment or in patients with mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion eller hos patienter med let til moderat nedsat nyrefunktion.
English: 3, choroidal detachment following filtration surgery
Danish: 3, choroidealøsning efter filtrationskirurgi
English: If you are changing from another eye drop medicine used to treat glaucoma to AZARGA, you should stop using the other medicine and start using AZARGA the following day.
Danish: Hvis du skifter til Azarga fra en anden type øjendråber til behandling af glaukom, skal du holde op med at bruge den anden medicin og begynde at bruge Azarga næste dag.
English: One of the active ingredients may impair the ability to perform tasks requiring mental alertness and/or physical coordination.
Danish: Et af de aktive stoffer kan forringe evnen til at udføre opgaver, der kræver mental årvågenhed og/eller fysisk koordination.
English: • The active substances are brinzolamide and timolol.
Danish: • Aktive stoffer: brinzolamid og timolol.
English: Not known: abnormal liver function test
Danish: Ikke kendt: Abnorm leverfunktionstest
English: • If you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heartbeats).
Danish: • Hvis du har en langsom puls, hjertesvigt eller forstyrrelser i hjerterytmen (uregelmæssig puls).
English: One ml of suspension contains 0.10 mg benzalkonium chloride.
Danish: 1 ml suspension indeholder 0,10 mg benzalkoniumchlorid.
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 brug af systemiske karboanhydrase-hæmmere.
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Danish: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona Spanien
English: • Hold the bottle, pointing down, between your thumb and fingers.
Danish: • Hold flasken med bunden i vejret mellem den ene hånds tommelfinger og de øvrige fingre.
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 doses of adrenaline used to treat anaphylactic reactions.
Danish: Under behandling med betablokkere kan patienter med en anamnese med atopi eller svære anafylaktiske reaktioner over for en række allergener være mere reaktive over for gentagen udsættelse for sådanne allergener og risikere ikke at respondere på normale doser af adrenalin til behandling af anafylaktiske reaktioner.
English: Only use AZARGA in both eyes if your doctor told you to. Take it for as long as your doctor told you to.
Danish: Brug kun Azarga i begge øjne, hvis lægen har anvist det.
English: Respiratory disorders
Danish: Respirationsforstyrrelser
English: Brinzolamide
Danish: Brinzolamid
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 (pH-værdi).
English: Following topical ocular administration, brinzolamide and timolol are absorbed through the cornea and into the systemic circulation.
Danish: Efter topikal okulær administration absorberes brinzolamid og timolol gennem kornea og over i det systemiske kredsløb.
English: Nervous system disorders Common: dysgeusia Not known: cerebral ischaemia
Danish: Almindelige: Dysgeusi Ikke kendt: Cerebral iskæmi
English: It is likely to be caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal and is attributable to brinzolamide.
Danish: Dysgeusi er sandsynligvis forårsaget af passage af øjendråberne til naso-pharynx via den nasolakrimale kanal og skyldes brinzolamid.
English: Do not put in any more drops until it is time for your next regular dose.
Danish: Dryp ikke flere dråber i øjet før næste planlagte dosis.
English: • coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure
Danish: • koronarsklerose (symptomer kan være brystsmerter eller trykken for brystet, åndenød eller kvælning), hjertesvigt, lavt blodtryk
English: Caution should be utilised in treating these patients and close monitoring of IOP is recommended.
Danish: Der skal udvises forsigtighed ved behandling af disse patienter, og det anbefales, at det intraokulære tryk overvåges tæt.
English: Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers.
Danish: Luftvejsreaktioner, herunder dødsfald som følge af bronkospasme hos patienter med astma, er indberettet efter administration af oftalmologiske betablokkere.
English: AZARGA has not been studied in patients with severe renal impairment (creatinine clearance <30 ml/min) or in patients with hyperchloraemic acidosis (see section 4.3).
Danish: Azarga er ikke undersøgt hos patienter med svært nedsat nyrefunktion (creatinin-clearance <30 ml/min) eller hos patienter med hyperkloræmisk acidose (se pkt.
English: • if you have a history of atopy (a tendency to develop an allergic reaction) and severe allergic reactions you may be more sensitive to developing an allergic reaction whilst using AZARGA
Danish: • hvis du har eller tidligere har haft atopi (en tendens til at udvikle en allergisk reaktion) og alvorlige allergiske reaktioner, kan du have øget risiko for at udvikle en allergisk reaktion, mens du bruger Azarga, og adrenalin vil muligvis ikke være effektiv til at behandle en allergisk reaktion.
English: CARTON FOR SINGLE BOTTLE 5 ml + CARTON FOR 3 x 5 ml BOTTLES
Danish: ÆSKE TIL ENKELT FLASKE, 5 ml + ÆSKE TIL 3 x 5 ml FLASKER
English: • disturbances of heart rate such as slow heart beat
Danish: • forstyrrelser i hjerterytmen såsom langsom puls
English: Beta blockers can decrease the response to adrenaline used to treat anaphylactic reactions.
Danish: Betablokkere kan mindske responset over for adrenalin, som bruges til at behandle anafylaktiske reaktioner.
English: To reduce the systemic absorption, see section 4.2.
Danish: 4.2 for reducering af systemisk absorption.
English: You should not use AZARGA if you are pregnant or might get pregnant, unless your doctor considers it necessary.
Danish: Hvis du er gravid, eller hvis du kan blive gravid, må du ikke bruge Azarga, medmindre din læge vurderer, at det er nødvendigt.
English: Non clinical data do not show any effects of either brinzolamide or timolol on male or female fertility following oral dosing.
Danish: Ikke-kliniske data viser ingen effekt af hverken brinzolamid eller timolol på fertiliteten hos hanner eller hunner efter oral dosering.
English: AZARGA contains benzalkonium chloride
Danish: Azarga indeholder benzalkoniumchlorid
English: No studies have been conducted with AZARGA or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment.
Danish: Der er ikke udført studier med Azarga eller timolol 5 mg/ml øjendråber hos patienter med nedsat lever- eller nyrefunktion.
English: Eye drops, suspension (eye drops)
Danish: Øjendråber, suspension (øjendråber).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from AZARGA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Når der træffes beslutning om, hvorvidt amning skal fortsættes/standses, eller hvorvidt behandling med Azarga skal fortsættes/ standses, skal der tages højde for fordele for barnet ved amning i henhold tilfordele for Azarga-behandlingen af kvinden.
English: Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Danish: Syre-base forstyrrelser er rapporteret ved orale karboanhydrase-hæmmere.
English: Dose-related decreases in foetal weights were observed in pups of dams receiving brinzolamide orally ranging from a slight decrease (about 5-6%) at 2 mg/kg/day to nearly 14% at 18 mg/kg/day.
Danish: Dosis-relateret nedsættelse i fostrenes kropsvægt blev observeret hos unger af rottemødre, der modtog oral brinzolamid og var fra et svagt fald (ca. 5-6 %) ved 2 mg/kg/dag til næsten 14 % ved 18 mg/kg/dag.
English: AZARGA has not been studied in patients with narrow-angle glaucoma and its use is not recommended in these patients.
Danish: Azarga er ikke vurderet hos patienter med snævervinklet glaukom, hvorfor det ikke bør anvendes til disse patienter.
English: AZARGA contains a preservative (benzalkonium chloride) which may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Danish: Azarga indeholder et konserveringsmiddel (benzalkoniumchlorid), som kan absorberes af bløde kontaktlinser og ændre farven på kontaklinserne.
English: Beta-blockers may also mask the signs of hyperthyroidism.
Danish: Betablokkere kan maskere tegn på hyperthyreoidisme.
English: Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.
Danish: De anførte bivirkninger inkluderer reaktioner, der er set inden for gruppen af oftalmologiske betablokkere.
English: • Hypersensitivity to other beta-blockers.
Danish: • Overfølsomhed over for andre betablokkere
English: Beta-adrenergic blocking medicinal products have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness).
Danish: Beta-adrenerge blokerende lægemidler er blevet rapporteret til at forstærke muskelsvaghed i overensstemmelse med visse symptomer på myasteni (f.eks. dobbeltsyn, ptose og generel svaghed).
English: To prevent contamination of the dropper tip and the suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Danish: For at undgå kontaminering af dråbespidsen og suspensionen skal man være opmærksom på ikke at berøre øjenlåget, omgivende områder eller andre overflader med spidsen af flasken.
English: The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent.
Danish: Virkningen på det intraokulære tryk eller de kendte virkninger af systemisk betablokade kan potenseres, når timolol gives til patienter, der allerede får en systemisk betablokker.
English: • Allergy: increased allergic symptoms, generalised allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing, hives, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
Danish: • Allergi: Øgede allergiske symptomer, generelle allergiske reaktioner herunder hævelse under huden, der kan forekomme på områder såsom ansigt og lemmer, og som kan blokere luftvejene og gøre det svært at synke og trække vejret, nældefeber, lokalt og generelt udslæt, kløe, pludselige alvorlige livstruende allergiske reaktioner.
English: The same types of adverse reactions that are attributable to sulphonamides may occur with topical administration.
Danish: Samme type bivirkninger, som tilskrives sulfonamider, kan ligeledes opstå ved topikal administration.
English: AZARGA should be used with caution in patients with severe hepatic impairment.
Danish: Azarga bør anvendes med forsigtighed til patienter med svært nedsat leverfunktion.
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 ved instillation, bør patienten vente med at føre motorkøretøj eller betjene maskiner, til synet er klart igen.
English: Tell your doctor if you are taking or intent to take medicines to lower blood pressure like parasympathomimetics and guanetidine, or other heart medicines including quinidine (used to treat heart conditions and some types of malaria), amiodarone or other medicines to treat heart rhythm disorders and glycosides to treat heart insufficiency.
Danish: Fortæl det til lægen, hvis du bruger eller overvejer at bruge lægemidler til sænkning af blodtrykket, såsom parasympatomimetika og guanetidin, eller anden hjertemedicin, som indeholder quinidin (bruges til behandling af hjertesygdomme og nogle typer malaria), amaiodaron eller andre lægemidler til at behandle hjerterytmeforstyrrelser og glykosider til at behandle nedsat hjertefunktion.
English: Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).
Danish: Betablokkere kan sløre symptomer på hypoglykæmi (se pkt 4.4).
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 kornea, herunder patienter med diabetes mellitus eller korneadystrofi, overvåges nøje.
English: (picture 2).
Danish: 2 minutter (billede 3).
English: Timolol is metabolised by two pathways.
Danish: Timolol metaboliseres ad to veje.
English: Beta-blockers are excreted in breast milk.
Danish: Betablokkere udskilles i mælk.
English: • breathing problems, asthma or chronic obstructive pulmonary disease
Danish: • vejrtrækningsbesvær, astma eller kronisk obstruktiv lungesygdom (KOL)