FrancophonIA/ELRC3.0 huggingface dataset:
English: Hot flushes
Danish: Muskelspasmer
English: If you take more Senshio than you should
Danish: Hvis du har taget for meget Senshio
English: Close monitoring is required with frequent or prolonged use.
Danish: Tæt overvågning er påkrævet ved hyppig eller langvarig anvendelse.
English: Date of first Authorisation: 25 November 2008 Date of latest renewal: 26 August 2013
Danish: Dato for første markedsføringstilladelse: 25. november 2008 Dato for seneste fornyelse: 26. august 2013
English: Contact with soft contact lenses should be avoided.
Danish: Kontakt med bløde kontaktlinser bør undgås.
English: Cartons containing 1 or 3 bottles.
Danish: Pakning indeholder 1 eller 3 flasker.
English: These could be the signs of an allergic reaction (frequency is not known).
Danish: Dette kan være tegn på en allergisk reaktion (hyppigheden er ikke kendt).
English: However, a risk to the suckling child cannot be excluded.
Danish: En risiko for det ammede barn kan ikke udelukkes.
English: The response of these patients should be closely observed.
Danish: Disse patienters reaktioner bør observeres tæt.
English: The drop will go in here (picture 1).
Danish: Dråben skal placeres der (billede 1).
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra forhåndenværende data):
English: 4 weeks after first opening.
Danish: 4 uger efter åbning.
English: Do not use a double dose to make up for the forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • Get the AZARGA bottle and a mirror.
Danish: • Hent Azarga-flasken og et spejl.
English: AZARGA should not be used during pregnancy unless clearly necessary.
Danish: AZARGA bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
English: • If you use drops in both eyes, repeat the steps for your other eye.
Danish: • Hvis du bruger dråber i begge øjne, gentages trinnene for det andet øje.
English: (predominantly in patients with preexisting bronchospastic disease), dyspnoea
Danish: (fortrinsvis hos patienter med eksisterende bronkospastisk sygdom), dyspnø
English: This helps to stop AZARGA getting into the rest of the body.
Danish: Det forhindrer, at Azarga optages i resten af kroppen.
English: If a drop misses your eye, try again.
Danish: Hvis dråben ikke rammer øjet, så prøv igen.
English: Do not drive or use machines until your vision is clear.
Danish: Du må ikke køre bil eller arbejde med maskiner, før dit syn er klart igen.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsberetninger for dette for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Caution is recommended.
Danish: Det anbefales derfor at udvise forsigtighed.
English: UNIQUE IDENTIFIER-2D BARCODE
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: This medicine contains 3.34 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.
Danish: Dette lægemiddel indeholder 3,34 µg benzalkoniumchlorid per dråbe (=1 dose) svarende til 0,01 % eller 0,1 mg/ml.
English: 2, increases in the signs and symptoms of myasthenia gravis
Danish: 2, intensivering af tegn og symptomer på myasthenia gravis
English: Studies have shown that timolol does not dialyse readily.
Danish: Studier har vist, at timolol ikke dialyseres umiddelbart.
English: If you stop using AZARGA without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.
Danish: Hvis du holder op med at bruge Azarga uden at tale med din læge, vil trykket i øjet ikke blive holdt nede, hvilket kan medføre tab af synet.
English: • Gently press on the base of the bottle to release one drop of AZARGA at a time.
Danish: • Tryk let på flaskens bund for at frigøre 1 dråbe Azarga ad gangen.
English: You can usually carry on taking the drops, unless the effects are serious.
Danish: Du kan oftest fortsætte med at bruge dine øjendråber, hvis bivirkningerne ikke er alvorlige.
English: The anaesthesiologist should be informed when the patient is receiving timolol.
Danish: Anæstesiologen skal informeres, hvis patienten får timolol.
English: Common: punctate keratitis
Danish: Almindelige: Punktat keratitis
English: No specific drug interaction studies have been performed with AZARGA.
Danish: Der er ikke udført specifikke interaktionsstudier med Azarga.
English: • If you have too much acidity in your blood (a condition called hyperchloraemic acidosis).
Danish: • Hvis du lider af for høj surhedsgrad i blodet (en tilstand kaldet ”hyperkloræmisk acidose”).
English: You may find that your vision is blurred for some time just after using AZARGA.
Danish: Dit syn kan blive sløret i et stykke tid lige efter, at du har brugt Azarga.
English: Hypoglycaemia/diabetes
Danish: Hypoglykæmi/diabetes
English: 1, asthma
Danish: 1, astma
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du og dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: AZARGA has minor influence on the ability to drive and use machines.
Danish: Azarga påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Patients with corneal diseases should be treated with caution.
Danish: Patienter med sygdomme i kornea skal behandles med forsigtighed.
English: In clinical trials, the most common adverse reactions were blurred vision, eye irritation and eye pain, occurring in approximately 2% to 7% of patients.
Danish: I kliniske forsøg var de mest almindelige bivirkninger sløret syn, øjenirritation og øjensmerter, som opstod hos omtrent 2 til 7 % af patienterne.
English: If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), talk to your doctor.
Danish: Hvis du anvender andre karboanhydrasehæmmere (acetazolamid eller dorzolamid)., tal med din læge.
English: Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.
Danish: Patienter med hjertekarsygdomme bør overvåges for tegn på forværring af disse sygdomme og for bivirkninger.
English: Do not stop using Azarga without speaking to your doctor first.
Danish: Du må ikke holde op med at bruge Azarga, uden at du har talt med din læge først.
English: One route yields an ethanolamine side chain on the thiadiazole ring and the other giving an ethanolic side chain on the morpholine nitrogen and a second similar side chain with a carbonyl group adjacent to the nitrogen.
Danish: Den ene vej giver en ethanolamin-sidekæde på thiadiazolringen, og den anden giver en ethanol-sidekæde på morfolin-nitrogen og en anden tilsvarende sidekæde med en karbonyl-gruppe tæt op ad nitrogenet.
English: Patients must be instructed to remove contact lenses prior to the application of AZARGA and wait 15 minutes after instillation of the dose before reinsertion.
Danish: Patienterne skal instrueres i at fjerne kontaktlinser før applikation af Azarga og vente 15 minutter efter instillation af dosis, før linserne sættes i igen.
English: Caution is recommended in the concomitant use of this medicinal product with clonidine.
Danish: Forsigtighed er påkrævet ved samtidig brug af dette lægemiddel og clonidin.
English: The safety and efficacy of AZARGA in children and adolescents aged 0 to 18 years have not yet been established.
Danish: Azargas sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er endnu ikke klarlagt.
English: Mental alertness
Danish: Mental årvågenhed
English: Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
Danish: Serumelektrolytniveauet (specielt kalium) og blodets pH-niveau bør monitoreres.
English: • Metabolism: low blood sugar levels.
Danish: • Stofskifte: Lavt blodsukkerniveau.
English: If overdose with AZARGA eye drops occurs, treatment should be symptomatic and supportive.
Danish: I tilfælde af overdosering med Azarga øjendråber, bør behandlingen være symptomatisk og understøttende.
English: Plasma protein binding of brinzolamide is moderate (about 60%).
Danish: Brinzolamids proteinbinding er moderat (ca. 60 %).
English: Throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle.
Danish: Flasken skal smides ud 4 uger efter åbning for at forhindre, at du får en infektion i øjet.
English: Studies have not been performed to evaluate the effect of topical ocular administration of Azarga on human fertility.
Danish: Der er ikke udført studier, der har undersøgt effekten af topikal okulær administration af Azarga på human fertilitet.
English: Timolol metabolism is mediated primarily by CYP2D6.
Danish: Metaboliseringen af timolol medieres primært ved CYP2D6.
English: , nervousness
Danish: , nervøsitet
English: Systemic effects
Danish: Systemiske virkninger
English: Talk to your doctor or pharmacist before using AZARGA if you have or have had in the past:
Danish: Kontakt lægen eller apotekspersonalet, inden du bruger Azarga, hvis du har eller tidligere har haft:
English: A statistically superior reduction in mean IOP was observed compared to both brinzolamide and timolol at all timepoints and visits throughout the study.
Danish: Der blev observeret en statistisk højere reduktion i det gennemsnitlige IOP sammenlignet med både brinzolamid og timolol på alle tidspunkter og ved alle besøg under hele studiet.
English: About 20% of the dose has been accounted for in urine as metabolite.
Danish: Omkring 20 % af en dosis blev fundet i urin som metabolit.
English: • muscular weakness (myasthenia gravis)
Danish: • muskelsvaghed (myastenia gravis)
English: Clinical effects:
Danish: Klinisk effekt:
English: • Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs
Danish: • Tryk ikke på siden af flasken: den er designet på en sådan måde, at et let tryk i bunden af den er alt, der skal til (billede 2).
English: There are no adequate data regarding the use of ophthalmic brinzolamide and timolol in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af oftalmisk brinzolamid eller timolol til gravide kvinder.
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 terapeutiske doser af timolol i øjendråber er det dog ikke sandsynligt, at mængden i mælken er tilstrækkelig til at give kliniske symptomer på betablokade hos spædbørn.
English: Brinzolamide is eliminated primarily by renal excretion (approximately 60%).
Danish: Brinzolamid elimineres primært ved renal udskillelse (ca. 60 %).
English: B-2870 Puurs Belgium or
Danish: 2870 Puurs
English: MedDRA Preferred Term (v. 18.0)
Danish: I henhold til MedDRA (v. 18.0)
English: 3, epistaxis bronchial hyperactivity
Danish: 3, epistaxis bronkial hyperaktivitet
English: • if you have dry eyes or cornea problems.
Danish: • hvis du har tørre øjne eller hornhindeproblemer
English: The plasma t1/2 of timolol is 4.8 hours after administration of AZARGA.
Danish: Timolols plasma t1/2 er 4,8 timer efter indgivelse af Azarga.
English: Tonography and fluorophotometry studies in man suggest that its predominant action is related to reduced aqueous humour formation and a slight increase in outflow facility.
Danish: Tonografiske og fluorofotometriske studier på mennesker tyder på, at dets dominerende virkning er relateret til reduceret dannelse af kammervæske og en let forøgelse af outflowet.
English: Eye ointments should be administered last.
Danish: Øjensalve skal påføres sidst.
English: Talk to your doctor before you use AZARGA.
Danish: Tal med din læge, før du begynder at bruge Azarga.
English: Dysgeusia (bitter or unusual taste in the mouth following instillation) was a frequently reported systemic adverse reaction associated with the use of AZARGA during clinical trials.
Danish: Dysgeusi (bitter eller unormal smag i munden efter drypning) var en hyppigt forekommende systemisk bivirkning forbundet med behandling med Azarga i de kliniske forsøg.
English: Following administration of AZARGA, mean Cmax of timolol was reached at 0.79 ± 0.45 hours.
Danish: Efter indgivelse af Azarga var det gennemsnitlige Cmax for timolol nået ved 0,79 ± 0,45 timer.
English: Acid/base disturbances
Danish: Syre/base-forstyrrelser
English: You may experience a decreased heart rate, decreased blood pressure, heart failure, difficulty breathing and your nervous system may be affected
Danish: Du kan opleve lav puls, lavt blodtryk, hjertesvigt, besvær med at trække vejret, og dit nervesystem kan blive påvirket.
English: AZARGA is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients that are more than 18 years of age and in whom high pressure in the eyes cannot be controlled effectively by one medicine alone.
Danish: Azarga bruges til at behandle for højt tryk i øjnene, også betegnet som glaukom eller okulær hypertension, hos voksne patienter over 18 år, som har højt tryk i øjnene, der ikke kan bringes effektivt under kontrol med et enkelt lægemiddel alene.
English: The following measure is useful to limit the amount of medicine that will come into the blood after application of eye drops: - Keep the eyelid closed, while simultaneously applying gentle pressure to the corner of the eye next to the nose with a finger for at least 2 minutes.
Danish: Følgende råd er nyttigt til at begrænse mængden af medicin, som overføres til blodbanen, efter at du har dryppet øjnene: - Hold øjenlåget lukket, mens du forsigtigt trykker ind mod øjenkrogen med fingeren i mindst
English: This medicinal product should be used with caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis.
Danish: Dette lægemiddel bør anvendes med forsigtighed hos patienter med risiko for nyreinsufficiens pga. den potentielle risiko for metabolsk acidose.
English: Approximately 20% of a timolol dose is excreted in the urine unchanged and the remainder excreted in urine as metabolites.
Danish: Cirka 20 % af en dosis timolol udskilles uændret via urinen, og resten udskilles i urinen som metabolitter.
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 forstyrrelser/lidelser i det perifere kredsløb (f.eks. alvorlige former for Raynauds sygdom eller Raynauds syndrom) bør behandles med forsigtighed.
English: • Brinzolamide and timolol are absorbed systemically.
Danish: • Brinzolamid og timolol absorberes systemisk.
English: • Hypersensitivity reactions common to all sulphonamide derivates can occur in patients receiving AZARGA as it is absorbed systemically.
Danish: • Overfølsomhedsreaktioner over for alle sulfonamidderivater kan opstå hos patienter, der behandles med Azarga, da det absorberes systemisk.
English: Timolol is a non-selective adrenergic-blocking agent that has no intrinsic sympathomimetic, direct myocardial depressant or membrane-stabilising activity.
Danish: Timolol er en ikke-selektiv blokker uden intrinsic sympatomimetisk, direkte myokardieldeprimerende eller membranstabiliserende effekt.
English: Patients should be instructed to shake the bottle well before use.
Danish: Patienterne skal instrueres i at ryste flasken grundigt inden brug.
English: In a pharmacokinetic study, healthy subjects received oral brinzolamide (1 mg) twice daily for 2 weeks to shorten the time to reach steady-state prior to starting AZARGA administration.
Danish: I et farmakokinetisk studie fik raske patienter oralt indgivet brinzolamid (1 mg) 2 gange dagligt i 2 uger for at forkorte tiden til steady-state, inden administration af Azarga.
English: Additional adverse reactions associated with the use of the individual components that may potentially occur with AZARGA are included in the table above.
Danish: Øvrige bivirkninger forbundet med brugen af stofferne individuelt, og som muligvis kan forekomme ved anvendelse af Azarga, er anført i tabellen ovenfor.
English: These findings occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased foetal weights.
Danish: Disse fund viste sig ved doser, som forårsagede metabolsk acidose med nedsat kropsvægtøgning hos rottemødrene og faldende kropsvægt hos fostrene.
English: At steady-state, timolol is detected in human plasma for up to 12 hours after administration of AZARGA.
Danish: Ved steady-state detekteres timolol i human plasma i op til 12 timer efter indgivelse af Azarga.
English: It may harm them even if their signs of illnesses are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
English: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Danish: Forbigående sløret syn eller andre synsforstyrrelser, som kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: The lower systemic exposure to timolol following AZARGA administration is not clinically relevant.
Danish: Den lavere systemiske eksponering for timolol efter anvendelse af Azarga er ikke klinisk relevant.
English: AZARGA can affect, or be affected by, other medicines you are taking, including other eye drops for the treatment of glaucoma.
Danish: Azarga kan påvirke eller påvirkes af andre lægemidler, som du tager, herunder andre øjendråber til behandling af glaukom (grøn stær).
English: Stop using this medicine and contact your doctor immediately if you develop skin rash, severe skin reaction, or severe redness and itching of the eye.
Danish: Ophør med at bruge dette lægemiddel, og søg straks læge, hvis du udvikler hududslæt, alvorlig hudreaktion eller kraftig rødme eller kløe i øjet.
English: Do not use AZARGA
Danish: Brug ikke Azarga
English: This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).
Danish: Dette kan medvirke til færre systemiske bivirkninger og øget virkning lokalt (se pkt.
English: Pharmacotherapeutic group: Ophthalmologicals, Antiglaucoma preparation and miotics ATC code: S01ED51
Danish: Farmakoterapeutisk klassifikation: Oftalmologiske lægemidler, antiglaukommiddel og miotika ATC-kode: S01ED51
English: Discard 4 weeks after first opening.
Danish: Kasseres 4 uger efter åbning.
English: The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking betablockers.
Danish: Den hypertensive reaktion på pludselig seponering af clonidin kan potenseres af betablokkere.
English: Eye drops, suspension
Danish: Øjendråber, suspension
English: They are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Danish: Nedenstående bivirkninger er klassificeret i henhold til følgende konvention og blev rapporteret under kliniske undersøgelser og overvågning af Azarga og brinzolamid og timolol som enkeltstoffer efter markedsføring: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: When receiving any other treatment please tell the doctor or nurse that you are taking AZARGA.
Danish: Hvis du får anden form for behandling, skal du derfor fortælle din læge eller sygeplejerske, at du bruger Azarga
English: System Organ Classification
Danish: Systemorganklasse
English: The possible role of brinzolamide on corneal endothelial function has not been investigated in patients with compromised corneas (particularly in patients with low endothelial cell count).
Danish: Brinzolamids mulige påvirkning af den korneale endotelfunktion er ikke vurderet hos patienter med skadet kornea (især hos patienter med lavt endotelcelletal).
English: AZARGA may be used while wearing contact lenses with careful monitoring (see below under ‘Benzalkonium chloride').
Danish: Azarga kan bruges, mens der bæres kontaktlinser, dog under omhyggelig monitorering (se nedenfor under Benzalkoniumchlorid).
English: The concomitant administration of AZARGA and oral carbonic anhydrase inhibitors has not been studied and is not recommended (see section 4.5).
Danish: Samtig administration af Azarga og orale karboanhydrasehæmmere er ikke undersøgt og anbefales ikke (se pkt.
English: Hydrochloric acid and/or sodium hydroxide (for pH adjustment) Purified water
Danish: Saltsyre og/eller natriumhydroxid (til at justere pH) Renset vand
English: • Use up one bottle before opening the next bottle.
Danish: • Brug hele flasken, inden du åbner en ny.
English: If you use more AZARGA than you should, rinse your eye with warm water.
Danish: Hvis du har brugt for meget Azarga, så skyl dit øje med varmt vand.
English: • Blood: abnormal liver function values, increased blood chlorine levels, or decreased red blood cell count as seen in a blood test.
Danish: • Blod: Unormale leverfunktionsværdier, øget klorinindhold i blodet eller nedsat antal røde blodlegemer, hvilket kan ses ved en blodprøve.
English: 3, bradycardia
Danish: 3, bradykardi
English: Brinzolamide is not an inhibitor of cytochrome P-450 isozymes.
Danish: Brinzolamid hæmmer ikke cytokrom P-450 isozymer.
English: However, accumulation of brinzolamide is unlikely as renal elimination is the major route.
Danish: Akkumulering af brinzolamid er usandsynlig, da dette hovedsagelig elimineres renalt.
English: • If you have now or have had in the past respiratory problems such as asthma, severe long lasting obstructive bronchitis (severe lung condition which may cause wheezing, difficulty in breathing and/or long standing cough) or other types of breathing problems.
Danish: • Hvis du har eller tidligere har haft luftvejsproblemer som f.eks. astma, alvorlig længerevarende obstruktiv bronkitis (alvorlig sygdom i lungerne, der kan give hvæsende vejrtrækning, vejrtrækningsbesvær og/eller længerevarende hoste) eller andre former for vejrtrækningsproblemer.
English: Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.
Danish: På grund af den negative effekt på overledningstiden bør betablokkere gives med forsigtighed til patienter med 1. grads hjerteblok.
English: Following twice daily dosing of AZARGA for 13 weeks, red blood cell (RBC) concentrations of brinzolamide averaged 18.8  3.29 µM, 18.1  2.68 µM and 18.4  3.01 µM at weeks 4, 10 and 15, respectively, indicating that steady-state RBC concentrations of brinzolamide were maintained
Danish: Efter doseringen af Azarga 2 gange dagligt i 13 uger var den gennemsnitlige koncentration af brinzolamid i de røde blodlegemer 18,8  3,29 µM, 18,1 2,68 µM og 18,4  3,01 µM i henholdsvis uge 4, 10 og 15, hvilket viser, at steady-state RBC-koncentrationer af brinzolamid blev opretholdt.
English: • After using AZARGA, press a finger into the corner of your eye, by the nose for 2 minutes
Danish: • Efter du har dryppet med Azarga, skal du trykke en finger mod øjenkrogen ind mod næsen i
English: White to off-white uniform suspension, pH 7.2 (approximately).
Danish: En hvid til råhvid, homogen suspension, pH ca. 7,2.