FrancophonIA/ELRC3.0 huggingface dataset:
English: • screening for kidney problems using laboratory tests is recommended for all patients before receiving these agents.
Danish: • screening for nyreproblemer ved hjælp af laboratorietest anbefales for alle patienter, før de gives disse stoffer.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that a number of measures need to be introduced into the prescribing information for these medicines, to minimise the risk of NSF associated with their use.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der skal føjes en række foranstaltninger til ordinationsoplysningerne for disse lægemidler for at minimere risikoen for NSF i forbindelse med anvendelsen heraf.
English: The CHMP has assessed all of the available information on the risks of NSF associated with the use of gadolinium-containing contrast agents, particularly those used in patients with kidney problems and patients receiving a liver transplant, in neonates and infants, the elderly and women who are pregnant or breastfeeding.
Danish: CHMP har vurderet alle de tilgængelige oplysninger om risikoen for NSF i forbindelse med anvendelsen af gadoliniumholdige kontraststoffer, særlig når disse anvendes hos patienter med nyreproblemer og patienter, der skal have en levertransplantation, hos nyfødte og spædbørn, ældre samt gravide og ammende kvinder.
English: • Doctors should record in the patient's notes the type and dose of contrast agent used.
Danish: • Lægen skal indføre i patientens papirer, hvilken type kontraststof der er blevet anvendt, og ved hvilken dosis.
English: • warnings should be added to the prescribing information for their use in patients with severe kidney problems and patients receiving a liver transplant;
Danish: • der skulle føjes advarsler til ordinationsoplysningerne for anvendelse af kontraststofferne hos patienter med svære nyreproblemer og patienter, der skal have foretaget en levertransplantation
English: Gadolinium-containing contrast agents are diagnostic agents used in patients undergoing a magnetic resonance imaging (MRI) scan.
Danish: Gadoliniumholdige kontraststoffer er diagnostiske midler, der anvendes hos patienter, som skal have foretaget en magnetisk resonans-scanning (MR-scanning).
English: To minimise the risk of NSF the Committee recommended a number of changes to the prescribing information of these medicines, depending on the risk classification of the agents.
Danish: For at minimere risikoen for NSF anbefalede CHMP, at der indføres en række ændringer i ordinationsoplysningerne for disse lægemidler, afhængig af hvilken risikogruppe stofferne tilhører.
English: For high-risk gadolinium-containing contrast agents, the CHMP recommended that:
Danish: For gadoliniumholdige kontraststoffer i højrisikogruppen anbefalede CHMP, at:
English: • all patients should be screened for kidney problems using laboratory tests before receiving these agents.
Danish: • alle patienter screenes for nyreproblemer ved hjælp af laboratorietest, før de gives disse stoffer.
English: • low risk: gadoteric acid (Dotarem), gadoteridol (ProHance) and gadobutrol (Gadovist).
Danish: • lav risiko: gadoterinsyre (Dotarem), gadoteridol (ProHance) og gadobutrol (Gadovist).
English: For medium- and low-risk agents the CHMP recommended that:
Danish: For gadoliniumholdige kontraststoffer i den middelhøje og lave risikogruppe anbefalede CHMP, at:
English: • their dose should be restricted to the minimum recommended dose in patients with moderate kidney problems and infants up to one year of age, and there should be at least a period of seven days between scans;
Danish: • dosis bør begrænses til den anbefalede minimumsdosis hos patienter med moderate nyreproblemer og spædbørn på op til ét år, og at der bør gå mindst syv dage imellem scanningerne
English: The SAG agreed with the PhVWP that the risk of developing NSF depends on the type of gadolinium-containing contrast agent used, and advised that these agents should be categorised into three groups:
Danish: Den videnskabelige rådgivende gruppe var enig med arbejdsgruppen vedrørende lægemiddelovervågning i, at risikoen for at udvikle NSF afhænger af, hvilken type gadoliniumholdige kontraststoffer der anvendes, og anbefalede, at disse stoffer blev kategoriseret i tre grupper:
English: • they must not be used in patients with severe kidney problems, in patients around the time of liver transplantation, and in newborn babies less than four weeks of age, who are known to have immature kidneys;
Danish: • disse ikke anvendes hos patienter med svære nyreproblemer, hos patienter, der står foran at skulle have foretaget en levertransplantation, eller hos nyfødte, der er under fire uger gamle og har underudviklede nyrer
English: • the decision to continue or suspend breastfeeding for at least 24 hours after a scan should be taken by the doctor and the mother;
Danish: • det er lægens og moderens afgørelse, om amningen skal fortsættes eller suspenderes i mindst 24 timer efter en scanning
English: • high risk: gadoversetamide (OptiMARK), gadodiamide (Omniscan) and gadopentetic acid
Danish: • høj risiko: gadoversetamid (OptiMARK), gadodiamid (Omniscan) og gadopentetinsyre
English: • their dose should be restricted to the minimum recommended dose in patients with severe kidney problems, patients around the time of liver transplantation and neonates and infants up to one year of age, and there should be at least a period of seven days between scans;
Danish: • dosis bør begrænses til den anbefalede minimumsdosis hos patienter med svære nyreproblemer og patienter, der står foran at skulle have foretaget en levertransplantation, samt hos nyfødte og spædbørn på op til ét år, og at der bør gå mindst syv dage imellem scanningerne
English: • medium risk: gadofosveset (Vasovist), gadoxetic acid (Primovist) and gadobenic acid
Danish: • middelhøj risiko: gadofosveset (Vasovist), gadoxetsyre (Primovist) og gadobensyre
English: Use at the same time each day.
Danish: Anvendes på samme tidspunkt hver dag.
English: Tilt your head back.
Danish: Læn hovedet tilbage.
English: Date of first authorisation: 18 July 2014 Date of last renewal: 20 February 2019
Danish: Dato for første markedsføringstilladelse: 18. juli 2014 Dato for seneste fornyelse: 20. februar 2019
English: Plasma concentrations are very low.
Danish: Plasmakoncentrationerne er meget lave.
English: You should also tell your doctor if the dose of any of your current medicines is changed.
Danish: Du skal også fortælle din læge hvis dosis af din nuværende medicin ændres.
English: Carton containing 1 or 3 bottles.
Danish: Pakninger med 1 eller 3 flasker.
English: Patients should be monitored in case of prolonged use.
Danish: Patienter bør monitoreres i tilfælde af langvaring anvendelse.
English: In rabbits, maximum ocular concentrations were achieved in less than one hour in most cases.
Danish: Hos kaniner blev de maksimale okulære koncentrationer opnået på mindre end en time i de fleste tilfælde.
English: All subjects were reported to have made a full recovery, usually within 6-24 hours.
Danish: Det blev rapporteret, at alle patienter kom sig fuldstændigt, som regel inden for 6-24 timer.
English: Contact with soft contact lenses should be avoided.
Danish: Kontakt med bløde kontaktlinser skal undgås.
English: Should this happen, contact your doctor immediately.
Danish: Hvis dette sker, skal du straks kontakte din læge.
English: Maximum human plasma concentrations are <1 ng/mL and achieved within <1 hour.
Danish: De maksimale humane plasmakoncentrationer er <1 ng/ml og opnås inden for <1 time.
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flasken og kartonen efter "EXP".
English: Missed dose If a dose is missed, treatment should be continued with the next dose as planned.
Danish: Glemt dosis Hvis en dosis bliver glemt, skal behandlingen fortsætte med næste dosis som planlagt.
English: Plasma levels decline with a half-life of approximately 2-3 hours.
Danish: Plasmaniveauerne falder med en halveringstid på cirka 2-3 timer.
English: Steady-state exposure does not increase in a doseproportional manner.
Danish: Steady-state-eksponering øges ikke proportionelt med dosis.
English: The IOP-lowering effect of brimonidine may be longer.
Danish: Den IOP-sænkende virkning af brimonidin kan vare længere.
English: Both substances work together to reduce pressure within the eye.
Danish: De to stoffer arbejder sammen om at sænke trykket i øjet.
English: The drop will go in here (picture 1).
Danish: Dråben skal placeres der (figur 1)
English: They are classified according to the subsequent convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data).
Danish: De er klassificeret i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (>1/100 til <1/10), ikke almindelig (>1/1.000 til ≤1/100), sjælden (>1/10.000 til ≤1/1000), meget sjælden (≤1/10.000), eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
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: BE-2870 Puurs Belgium or
Danish: BE-2870 Puurs Belgium eller
English: The patient's airway should be maintained.
Danish: Patientens luftveje skal holdes åbne.
English: Do not put in any more drops until it is time for your next regular dose.
Danish: Dryp ikke flere dråber i øjnene, før det er tid til næste dosis.
English: It is particularly important that the medicine is not used in children under the age of 2 years (see section ‘Do not use SIMBRINZA' above) because it is unlikely to be safe.
Danish: Det er især vigtigt, at medicinen ikke anvendes til børn under 2 år (se punktet "Brug ikke SIMBRINZA" ovenfor), da det sandsynligvis ikke er sikkert.
English: The only adverse reaction reported to date was hypotension.
Danish: Den eneste indberettede bivirkning til dato var hypotension.
English: The frequency of an allergic reaction to the medicine is not known (frequency cannot be estimated from the available data).
Danish: Hyppigheden af en allergisk reaktion på lægemidlet er ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data).
English: Contact your doctor immediately if you develop extreme tiredness or dizziness.
Danish: Kontakt straks lægen, hvis du oplever ekstrem træthed eller svimmelhed.
English: It was reported that the hypotensive episode was followed by rebound hypertension.
Danish: Det blev rapporteret, at den hypotensive episode blev efterfulgt af rebound-hypertension.
English: If allergic reactions are observed, treatment should be discontinued.
Danish: Hvis der observeres allergiske reaktioner, skal behandlingen seponeres.
English: However, clinical and non-clinical safety data show it to be welltolerated and safe during chronic administration.
Danish: Imidlertid viser de kliniske og prækliniske sikkerhedsdata sig at være veltolererede og sikre under kronisk administration.
English: If overdose with SIMBRINZA occurs treatment should be symptomatic and supportive.
Danish: I tilfælde af overdosering med SIMBRINZA bør behandlingen være symptomatisk og understøttende.
English: Very rare: uveitis
Danish: Meget sjælden: uveitis
English: Oxidative cleavage of the imidazoline ring to 5-bromo-6-guanidinoquinoxaline is also observed.
Danish: Oxidativ kløvning af imidazolin-ringen til 5-bromo-6-guanidinoquinoxalin observeres også.
English: All treatment differences (SIMBRINZA versus individual components) were statistically significant with p=0.0001 or less.
Danish: Alle behandlingsforskelle (SIMBRINZA over for enkelte komponenter) var statistisk signifikante med p=0,0001 eller derunder.
English: Throw away the bottle 4 weeks after first opening to prevent infections and use a new bottle.
Danish: Flasken skal kasseres 4 uger efter åbning for at forhindre øjeninfektioner, og en ny flaske skal tages i brug.
English: SIMBRINZA is not intended for use by children and adolescents aged below 18 years because it has not been studied in this age group.
Danish: SIMBRINZA er ikke beregnet til brug hos børn og unge under 18 år, da der ikke er gennemført studier for denne aldersgruppe.
English: No accumulation occurs during chronic administration.
Danish: Der opstår ingen akkumulation under kronisk administration.
English: A study of brinzolamide in Japanese versus non-Japanese subjects showed similar systemic pharmacokinetics between the two groups.
Danish: Et studie med brinzolamid i japanske over for ikke-japanske forsøgspersoner viste lignende systemisk farmakokinetik mellem de to grupper.
English: Do not stop using SIMBRINZA without first speaking to your doctor.
Danish: Du må ikke holde op med at bruge SIMBRINZA, uden først at tale med din læge.
English: To reduce the amount of medicine that could come into the rest of the body after application of the eye drop, close your eye and apply gentle pressure to the corner of the eye next to the nose with a finger for at least 2 minutes.
Danish: For at reducere mængden af medicin, som kan optages i resten af kroppen efter inddrypning af øjendråben, skal du lukke dit øje og forsigtigt trykke en finger mod øjenkrogen ind mod næsen i mindst 2 minutter.
English: The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established.
Danish: SIMBRINZAs sikkerhed og virkning hos børn og unge i alderen 2 til 17 år er ikke klarlagt.
English: There are no or limited amount of data from the use of SIMBRINZA in pregnant women.
Danish: Der er ingen eller begrænsede data fra anvendelse af SIMBRINZA til gravide kvinder.
English: Patients with hyperchloraemic acidosis.
Danish: Patienter med hyperkloræmisk acidose.
English: Given the low systemic exposure to brimonidine following topical ocular administration, it is expected that changes in plasma exposure would not be clinically relevant.
Danish: Idet der tages højde for den lave systemiske eksponering for brimonidin efter topikal okulær administration, forventes det, at ændringer i plasmaeksponeringen ikke vil være af klinisk relevans.
English: Brinzolamide is moderately (about 60%) bound to human plasma proteins.
Danish: Brinzolamid har en moderat (ca. 60 %) binding til humane plasmaproteiner.
English: However, the combination product is not recommended for patients with severe renal impairment (creatinine clearance <30 mL/minute).
Danish: Kombinationsproduktet anbefales imidlertid ikke til patienter med svær nyreinsufficiens (kreatinin-clearance <30 ml/minut).
English: If you experience any of the following side effects, please stop using this medicine and seek immediate medical attention as these could be signs of a reaction to the medicine.
Danish: Hvis du oplever en eller flere af følgende bivirkninger, skal du straks holde op med at bruge dette lægemiddel og søge læge, da det kan være tegn på en reaktion på medicinen.
English: The medicinal product should not be injected.
Danish: Lægemidlet må ikke injiceres.
English: Do not touch the dropper with your fingers when opening or closing the bottle.
Danish: Undgå at røre ved spidsen med fingrene, når du åbner og lukker flasken.
English: Data in rats showed some biliary excretion (about 30%), primarily as metabolites.
Danish: Data fra rotter viste nogen grad af udskillelse via galdevejene (ca. 30 %), primært som metabolitter.
English: Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2).
Danish: Tryk ikke på siden af flasken, da den er designet på en sådan måde, at et let tryk i bunden af flasken er alt, der skal til (figur 2).
English: • General side effects: fainting, increased blood pressure
Danish: • Generelle bivirkninger: besvimelse, forhøjet blodtryk
English: Animal studies with oral brimonidine do not indicate direct harmful effects with respect to reproductive toxicity.
Danish: Dyrestudier med oral brimonidin indikerer ikke direkte skadelige virkninger, hvad angår reproduktionstoksicitet.
English: Serum electrolyte levels (particularly potassium) and blood pH levels must be monitored.
Danish: Serumelektrolytniveauer (især kalium) og blodets pH-niveau skal monitoreres.
English: In rats and monkeys, urinary metabolites accounted for 60 to 75% of oral or intravenous doses.
Danish: I rotter og aber udgjorde urinvejsmetabolitter 60 til 75 % af de orale eller intravenøse doser.
English: There are no efficacy and safety data for adjunct therapy beyond 6 weeks.
Danish: Der er ingen effekt- og sikkerhedsdata for kombinationsbehandling efter 6 ugers behandling.
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 rolig lukning af øjnene efter inddrypning kan reducere forekomsten af denne bivirkning (se afsnit 4.2).
English: Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Danish: Gør det foran et spejl, hvis det hjælper.
English: In contrast, brimonidine exhibits linear pharmacokinetics over the clinically therapeutic dose range.
Danish: Tværtimod udviser brimonidin lineær farmakokinetik over det kliniske terapeutiske dosisområde.
English: If you stop using SIMBRINZA the pressure in your eye will not be controlled, which could lead to loss of sight.
Danish: Hvis du holder op med at bruge SIMBRINZA uden at tale med din læge, vil trykket i øjet ikke blive holdt nede, hvilket kan medføre tab af synet.
English: While the duration of IOP-lowering effect for SIMBRINZA has not been studied, the IOP-lowering effect of brinzolamide is expected to last for 5-7 days.
Danish: Varigheden af den IOP-sænkende virkning af SIMBRINZA er ikke blevet undersøgt, men den IOPsænkende virkning af brinzolamid forventes at vare 5-7 dage.
English: This increase in steady-state RBC concentrations of substance-related material did not inhibit RBC carbonic anhydrase activity to levels that are associated with systemic side effects.
Danish: Stigningen i steady-state-RBC-koncentrationerne fra stof-relateret materiale hæmmede ikke aktiviteten fra RBC-karboanhydrase til niveauer, som var forbundne med systemiske bivirkninger.
English: The substance is also absorbed into the systemic circulation, where it binds strongly to carbonic anhydrase in red blood cells (RBCs).
Danish: Stoffet absorberes også i det systemiske kredsløb, hvor det bindes kraftigt til karboanhydrase i de røde blodlegemer (RBC).
English: The possible effect of brinzolamide on corneal endothelial function has not been investigated in patients with compromised corneas (particularly in patients with low endothelial cell count).
Danish: Den mulige virkning af brinzolamid på korneal endotelfunktion er ikke blevet undersøgt hos patienter med kompromitteret cornea (især hos patienter med lavt endotel celletal).
English: Following administration of SIMBRINZA, small decreases in blood pressure were observed in some patients.
Danish: Efter administration af SIMBRINZA blev der observeret et mindre fald i blodtrykket hos nogle patienter.
English: Brimonidine is rapidly absorbed into the eye following topical administration.
Danish: Brimonidin absorberes hurtigt i øjet efter topikal administration.
English: The Cmax, AUC and elimination half-life of brimonidine are similar in elderly (>65 years of age) subjects compared to young adults.
Danish: Cmax, AUC og eliminationshalveringstiden for brimonidin hos ældre (>65 år) forsøgspersoner er sammenlignelig med unge voksne.
English: Alpha adrenergic agonists (e.g. brimonidine tartrate), as a class, may reduce pulse and blood pressure.
Danish: Alfa-adrenerge agonister (f.eks. brimonidintartrat) som klasse kan nedsætte puls og blodtryk.
English: Write down the date of opening on the carton in the space provided.
Danish: Skriv åbningsdatoen, hvor der er gjort plads til dette på kartonen.
English: This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).
Danish: Dette kan nedsætte forekomsten af systemiske bivirkninger og give en øget lokal aktivitet (se pkt.
English: Gently press on the base of the bottle to release one drop of SIMBRINZA.
Danish: Tryk let på flaskens bund for at frigøre en dråbe SIMBRINZA.
English: OUTER CARTON 5 ml BOTTLE
Danish: YDERKARTON 5 ml FLASKE
English: 2, insomnia
Danish: 2, insomni
English: If you are using other eye drops as well as SIMBRINZA, wait at least five minutes between using SIMBRINZA and the other drops.
Danish: Hvis du bruger andre øjendråber udover SIMBRINZA, så vent mindst 5 minutter mellem SIMBRINZA og de andre øjendråber.
English: Delayed ocular hypersensitivity reactions have been reported with brimonidine tartrate, with some reported to be associated with an increase in IOP.
Danish: Forsinkede okulære overfølsomhedsreaktioner er blevet rapporteret med brimonidintartrat, hvoraf nogle er blevet rapporteret til at være forbundne med en stigning i IOP.
English: Only use SIMBRINZA for your eyes.
Danish: SIMBRINZA må kun bruges i øjnene.
English: The systemic pharmacokinetics of brinzolamide and brimonidine, alone or in combination, in paediatric patients have not been studied.
Danish: Den systemiske farmakokinetik for brinzolamid og brimonidin, alene eller i kombination, i pædiatriske patienter er ikke blevet undersøgt.
English: 2, alopecia
Danish: 2, alopeci
English: The use of brimonidine has been associated with minimal decreases in blood pressure.
Danish: Brugen af brimonidin er blevet forbundet med minimale blodtryksfald.
English: Patients should be instructed not to swallow SIMBRINZA.
Danish: Patienterne skal instrueres i ikke at indtage SIMBRINZA oralt.
English: The potential effects following cessation of treatment with SIMBRINZA have not been studied.
Danish: Den potentielle virkning efter seponering af behandling med SIMBRINZA er ikke blevet undersøgt.
English: SIMBRINZA may also cause dizziness, drowsiness or tiredness in some patients.
Danish: SIMBRINZA kan også medføre svimmelhed, døsighed eller træthed hos nogle patienter.
English: You may find that your vision is blurred or abnormal for a time just after using SIMBRINZA.
Danish: Dit syn kan blive sløret eller unormalt umiddelbart efter anvendelse af SIMBRINZA.
English: This medicine contains 0.15 mg benzalkonium chloride in each 5 ml, which is equivalent to 0.03 mg/ml.
Danish: Dette lægemiddel indeholder 0,15 mg benzalkoniumchlorid pr. 5 ml, svarende til 0,03 mg/ml.
English: If you are breast-feeding, SIMBRINZA may pass into your milk.
Danish: Hvis du ammer, kan SIMBRINZA gå over i modermælken.
English: SIMBRINZA is absorbed systemically and this may therefore occur with topical administration (see section 4.7).
Danish: SIMBRINZA absorberes systemisk, og dette kan derfor forekomme ved topikal administration (se pkt.
English: SIMBRINZA can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
Danish: SIMBRINZA kan påvirke eller påvirkes af andre lægemidler, du tager, herunder andre øjendråber til behandling af glaukom (grøn stær).
English: Not known (frequency cannot be estimated from the available data)
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data)
English: To prevent contamination of the dropper tip and solution, 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: Treatment of children 2 years and above (especially those in the 2-7 age range and/or weighing <20 kg) is not recommended because of the potential for central nervous system-related side effects (see section 4.9).
Danish: Behandling af børn fra 2 år og opefter (især børn i alderen 2-7 år og/eller med en kropsvægt på <20 kg) anbefales ikke, idet der er risiko for bivirkninger, der påvirker centralnervesystemet (se pkt.