FrancophonIA/ELRC3.0 huggingface dataset:
English: In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays ‘trapped' until it is eliminated from the body in the urine.
Danish: Gadolinium binder sig i Optimark til et andet kemisk stof, så metallet ikke frigives i kroppen, men er "fanget", indtil det udskilles af kroppen i urinen.
English: It is used in adults and in children from two years of age who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken.
Danish: Det anvendes til voksne og børn fra toårsalderen, som får foretaget magnetisk resonans billeddannelse (MRI), en form for scanning, hvor der tages billeder af de indre organer.
English: Optimark allows images to be taken for up to an hour after it has been injected, although the best time to take a scan depends on the location and type of abnormality that is being examined.
Danish: Optimark giver mulighed for at foretage scanning i indtil en time, efter at det er blevet injiceret, men det bedste tidspunkt til scanning afhænger af beliggenheden og arten af den forandring, der skal undersøges.
English: NSF causes thickening of the skin and connective tissues.
Danish: NSF medfører fortykkelse af hud og bindevæv.
English: Optimark has been studied in four main studies involving a total of 804 patients who had or were thought to have abnormalities in the brain or spine (two studies in 401 patients) or in the liver (two studies in 403 patients).
Danish: Optimark blev undersøgt i fire hovedundersøgelser med i alt 804 patienter, der havde eller formodedes at have forandringer i hjernen eller rygsøjlen (to undersøgelser med 401 patienter) eller i leveren (to undersøgelser med 403 patienter).
English: MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body.
Danish: MRI er en billeddannelsesmetode, hvor man udnytter de små magnetfelter, der frembringes af vandmolekyler i kroppen.
English: The CHMP decided that Optimark's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP var af den opfattelse, at fordelene ved Optimark opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Optimark.
English: Once injected, gadolinium interacts with the water molecules.
Danish: Når gadolinium er indsprøjtet, vekselvirker det med vandmolekylerne.
English: Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver.
Danish: Optimark anvendes til at få et klarere billede ved scanning af patienter, der har eller formodes at have forandringer i hjernen, rygsøjlen eller leveren.
English: As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Danish: Denne vekselvirkning bevirker, at signalet fra vandmolekylerne bliver kraftigere, så billedet bliver klarere.
English: Optimark must not be used in people who are hypersensitive (allergic) to gadoversetamide, any of the other ingredients or other medicines containing gadolinium.
Danish: Optimark må ikke anvendes til patienter, der er overfølsomme (allergiske) over for gadoversetamid, andre af indholdsstofferne eller andre lægemidler indeholdende gadolinium.
English: In all of the studies, Optimark was as effective as the comparator contrast agent in improving the ability to see abnormalities on the scans.
Danish: I alle undersøgelserne var Optimark lige så effektivt som sammenligningskontrastmidlet til at gøre forandringerne mere synlige på scanningerne.
English: In all of the studies, the effects of Optimark were compared with those of gadopentetate dimeglumine (another contrast agent containing gadolinium).
Danish: I alle undersøgelserne blev virkningerne af Optimark sammenlignet med virkningerne af dimeglumingadopentetat (et andet kontrastmiddel, der indeholder gadolinium).
English: In the studies of liver abnormalities, both medicines increased the score by an average of 0.38 points from a baseline of 1.82 points.
Danish: I undersøgelserne af leverforandringer gav begge midler en score-forbedring på gennemsnitligt 0,38 point fra et basisniveau på 1,82 point.
English: Gadolinium is used as a ‘contrast agent' to help obtain better images with MRI scans.
Danish: Gadolinium anvendes som kontraststof for at få bedre billeder ved MRIscanning.
English: The active substance in Optimark, gadoversetamide, contains gadolinium, a ‘rare-earth' metal element.
Danish: Det aktive stof i Optimark, gadoversetamid, indeholder gadolinium, der er et grundstof i gruppen af "sjældne jordarters" metaller.
English: What is the risk associated with Optimark?
Danish: Hvilken risiko er der forbundet med Optimark?
English: Optimark is a solution for injection that contains the active substance gadoversetamide.
Danish: Optimark er en injektionsvæske, der indeholder det aktive stof gadoversetamid.
English: In the two studies of brain and spine abnormalities taken together, scans taken with Optimark had a score increase of 0.63 points on average from a ‘baseline' of 1.58 points without Optimark.
Danish: Hvis man tager resultaterne af de to undersøgelser af hjerne- og rygsøjleforandringer under ét, bevirkede Optimark en gennemsnitlig score-forbedring på 0,63 point (fra en "bundlinje" på 1,58 point uden Optimark).
English: The main measure of effectiveness was the difference in the ability to see the abnormalities on MRI scans taken with and without the contrast agent.
Danish: Virkningen blev hovedsagelig bedømt på forskellen i, hvor tydeligt forandringerne kunne ses ved MRIscanning med og uden kontrastmidlet.
English: Why has Optimark been approved?
Danish: Hvorfor blev Optimark godkendt?
English: The most common side effects with Optimark (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances) and feeling hot. For the full list of all side effects reported with Optimark, see the package leaflet.
Danish: De hyppigste bivirkninger ved Optimark (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, smagsforstyrrelser og varmefornemmelse.
English: What is Optimark?
Danish: Hvad er Optimark?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Optimark have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Optimark.
English: This compared with an increase of 0.66 points with the comparator contrast agent, from a baseline of 1.60 points.
Danish: Sammenligningskontrastmidlet gav en tilsvarende forbedring (0,66 point i forhold til en bundlinje på 1,60 point).
English: How has Optimark been studied?
Danish: Hvordan blev Optimark undersøgt?
English: What benefit has Optimark shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Optimark?
English: What is Optimark used for?
Danish: Hvad anvendes Optimark til?
English: It is available in prefilled syringes and in vials.
Danish: Lægemidlet fås i fyldte injektionssprøjter og i hætteglas.
English: When looking at certain abnormalities in the brain, Optimark may need to be used at a higher dose, or the dose may need to be repeated.
Danish: Til undersøgelse af visse forandringer i hjernen kan det være nødvendigt at bruge en højere dosis af Optimark eller gentage den. En gentagen dosis anbefales ikke hos børn, patienter med nyreproblemer eller ældre patienter.
English: How is Optimark used?
Danish: Hvordan anvendes Optimark?
English: How does Optimark work?
Danish: Hvordan virker Optimark?
English: Strength Pharmaceutical Form Route of Administration
Danish: (Sær)navn Styrke Lægemiddelform Administration Emballage
English: MA (EU) number Invented name Strength Pharmaceutical form
Danish: MF (EU)-nummer
English: White suspension.
Danish: Hvid suspension.
English: However, you will not get the right amount of medicine if you keep using it.
Danish: Men du vil ikke få den rette mængde medicin, hvis du fortsætter med at bruge den.
English: It is important to instruct the patient to:
Danish: Det er vigtigt at instruere patienten i følgende:
English: Always tell your doctor about other health problems.
Danish: Fortæl altid din læge om andre helbredsmæssige problemer.
English: These include:
Danish: Dette omfatter:
English: Date of first authorisation: 18 December 2018
Danish: Dato for første markedsføringstilladelse: 18. december 2018
English: Therefore, statistical significance on this comparison cannot be inferred.
Danish: Derfor kan statistisk signifikans for denne sammenligning ikke udledes.
English: • high blood sugar levels
Danish: • højt blodsukkerniveau
English: Preferred term
Danish: Foretrukken term
English: Both central and peripheral deposition were observed.
Danish: Både central og perifer deponering blev set.
English: You may need medical attention.
Danish: Du kan måske have behov for lægehjælp.
English: Note: Patients should be instructed on the correct inhalation technique.
Danish: Bemærk: Patienter bør instrueres i den korrekte inhalationsteknik.
English: • you have asthma.
Danish: • du har astma.
English: How much to use
Danish: Hvor meget skal der bruges
English: For pharmacokinetic purposes each component can therefore be considered separately.
Danish: Til farmakokinetiske formål kan hver komponent derfor betragtes separat.
English: Your inhaler may not feel empty and it may seem as though it still works.
Danish: Din inhalator føles måske ikke tom, og det kan virke som om, den stadig fungerer.
English: If there is any built-up medicine, repeat Steps 3 to 5 in the section.
Danish: Hvis der er medicinrester tilbage, gentag trin 3 til 5 i dette afsnit.
English: Clean the inhaler once each week for the first 3 weeks.
Danish: Rengør inhalatoren én gang hver uge i de første 3 uger.
English: If this occurs, do not drive or use machines.
Danish: Hvis dette sker, må du ikke køre bil eller betjene maskiner.
English: If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.
Danish: Hvis en dosis glemmes, skal den tages hurtigst muligt, og den næste dosis bør tages på det sædvanlige tidspunkt.
English: It will help to reduce the effects of COPD on your everyday life.
Danish: Det vil det hjælpe til at nedsætte påvirkningen fra KOL i din hverdag.
English: There were no major differences in total systemic exposure (AUC) for both compounds between healthy Japanese and Western subjects.
Danish: Der var ingen store forskelle i total systemisk eksponering (AUC) for de to forbindelser mellem japanske og vestlige forsøgspersoner.
English: SAC-TDI / TDI Focal Score
Danish: SAC-TDI/TDI fokal score
English: This medicine is for long-term use.
Danish: Denne medicin er beregnet til langtidsbrug.
English: Do not use this medicine for asthma
Danish: Brug ikke denne medicin mod astma
English: Component of a multipack, cannot be sold separately.
Danish: Del af multipakning - må ikke sælges separat.
English: These patients should be monitored for potential adverse reactions.
Danish: Disse patienter bør monitoreres for potentielle bivirkninger.
English: The frequency of adverse reactions is defined using 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 <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: Hyppigheden af bivirkninger er defineret ved hjælp af 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 <1.000); meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Danish: Hvis overdosering finder sted, skal patienten behandles understøttende med passende monitorering efter behov.
English: • you have heart problems
Danish: • du har hjerteproblemer
English: PINNACLE 4 used TDI.
Danish: PINNACLE 4 anvendte TDI.
English: Table 1Adverse reactions by frequency and system organ class (SOC)
Danish: Tabel 1Bivirkninger efter hyppighed og systemorganklasse (SOC) Systemorganklasse
English: Insufficient pharmacokinetic data are available to compare exposure for other ethnicities or races.
Danish: Utilstrækkelige farmakokinetiske data er tilgængelige til sammenligning af eksponeringen for andre etniske grupper eller racer.
English: Not for acute use
Danish: Ikke til akut anvendelse
English: • When the arrow reaches ‘0', you must stop using your inhaler.
Danish: • Når pilen når "0" skal du stoppe med at bruge inhalatoren.
English: It is important to use Bevespi Aerosphere every day, even if you have no COPD symptoms at the time.
Danish: Det er vigtigt at bruge Bevespi Aerosphere hver dag, selvom du ikke har nogen KOL-symptomer på det tidspunkt.
English: Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Danish: Patienter med klinisk signifikant ukontrolleret kardiovaskulær sygdom var ekskluderet fra kliniske studier.
English: You may hear a soft click from the dose indicator as it counts down during use.
Danish: Du kan høre et blødt klik fra dosisindikatoren, når den tæller ned under brug.
English: There was no attenuation of the bronchodilator effect over time.
Danish: Der var ingen dæmpning af bronkodilatorvirkningen over tid.
English: Effect of a spacer
Danish: Effekt med en spacerenhed
English: • Talk to your doctor or pharmacist if you have any questions about the use of your inhaler.
Danish: • Tal med lægen eller apotekspersonalet hvis du har nogle spørgsmål om brugen af din inhalator.
English: If you want to stop treatment, first talk to your doctor.
Danish: Hvis du vil stoppe behandlingen, skal du først tale med din læge.
English: Date pouch opened:__________
Danish: Dato for åbning af pose:___________
English: Your inhaler is now ready to use.
Danish: Din inhalator er nu klar til brug.
English: WEEK 12
Danish: Uge 12
English: It is unlikely that this medicine will affect your ability to drive and use machines.
Danish: Det er usandsynligt, at dette lægemiddel vil påvirke din evne til at køre bil og anvende maskiner.
English: This could cause a puff of medicine to be released.
Danish: Dette kan medføre, at et pust medicin frigives.
English: • medicines which can prolong ‘QT interval' (a change in the electrical activity of the heart).
Danish: • medicin, som kan forlænge "QT-intervallet" (en forandring i hjertets elektriske impulser).
English: No evidence of carcinogenicity was seen in 2-year studies in rats and mice.
Danish: Der blev ikke fundet tegn på karcinogenicitet i 2-årige studier med rotter og mus.
English: Other antimuscarinics and sympatomimetics
Danish: Andre antimuskariner og sympatomimetika
English: • After priming 4 times, the dose indicator should be pointing to the right of “120” and your inhaler is now ready to use.
Danish: • Efter 4 gange klargøring bør dosisindikatoren pege direkte på ”120”, og din inhalator er nu klar til brug.
English: Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Danish: Brug ikke denne medicin til at behandle et pludseligt anfald af vejrtrækningsbesvær eller hvæsen.
English: The combination of these substances with different mechanisms of action results in additive efficacy compared to use with either component alone.
Danish: Kombinationen af disse stoffer med forskellige virkningsmekanismer resulterer i additiv effekt sammenlignet med anvendelse af hvert stof alene.
English: Patients should be advised not to take more than 2 inhalations twice daily.
Danish: Patienterne bør instrueres i ikke at tage mere end 2 inhalationer to gange dagligt.
English: • The colour in the dose indicator display window will change to red, as shown in the shaded area, when there are only 20 puffs of medicine left in your inhaler (See Figure 2d).
Danish: • Farven i dosisindikatorvinduet ændres til rød, som vist med det mørktfarvede område, når der kun er 20 doser lægemiddel tilbage i din inhalator (se figur 2d).
English: The recommended dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening).
Danish: Den anbefalede dosis er to inhalationer to gange dagligt (to inhalationer om morgenen og to inhalationer om aftenen).
English: Hold your breath as long as you comfortably can, up to 10 seconds (See Figure 11).
Danish: Hold vejret så længe du kan, uden det bliver ubehageligt, op til 10 sekunder (se figur 11).
English: o Throw away the pouch and the drying packet.
Danish: o Smid posen og tørrepakken ud.
English: Concurrent use of either non-selective or selective β-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Danish: Samtidig brug af enten ikke-selektive eller selektive β-adrenerge blokkere bør undgås medmindre der er tungtvejende årsager til at bruge dem.
English: OUTER CARTON, MULTIPACK - WITH BLUE BOX
Danish: YDRE KARTON, MULTIPAKNING - MED BLUE BOX
English: Step 6: When you have finished breathing in, remove the mouthpiece from your mouth.
Danish: Trin 6: Når du er færdig med at trække vejret ind, skal du fjerne mundstykket fra munden.
English: These belong to a group of medicines called long-acting bronchodilators.
Danish: Disse tilhører en gruppe lægemidler, der kaldes langtidsvirkende bronkodilatorer.
English: This information should be used alongside a discussion with your doctor about your medical condition and treatment.
Danish: Anvisningen skal bruges sammen med en samtale med din læge angående din sygdom og behandling.
English: Then stop pressing the dose indicator.
Danish: Stop derefter med at trykke på dosisindikatoren.
English: Step 3: Hold the actuator under the tap and run warm water through it for about 30 seconds.
Danish: Trin 3: Hold plasthylsteret under vandhanen og lad varmt vand løbe igennem det i cirka 30 sekunder.
English: COPD is a long-term disease of the airways in the lungs, which is often caused by smoking.
Danish: KOL er en langvarig sygdom i luftvejene i lungerne, som ofte skyldes rygning.
English: Step 4: Shake off as much water from the actuator as you can.
Danish: Trin 4: Ryst så meget vand som muligt af plasthylsteret.
English: A puff of medicine is released each time you press the centre of the dose indicator.
Danish: En dosis medicin frigives hver gang, du trykker midt på dosisindikatoren.
English: The safety profile is characterised by anticholinergic and β2-adrenergic class effects related to the individual components of the combination.
Danish: Sikkerhedsprofilen er karakteriseret ved antikolinerge og β2-adrenerge klasseeffekter relateret til de enkelte komponenter i kombinationen.
English: Figure 1 - Mean Change from Baseline in FEV1 over Time on Day 1 and at Week 12
Danish: Figur 1 - Gennemsnitsændring fra baseline i FEV1 over tid på dag 1 og ved uge 12
English: - you are allergic to glycopyrronium, formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).
Danish: - du er allergisk over for glycopyrronium, formoterolfumaratdihydrat eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: The individual studies were not specifically designed to evaluate the effect of treatments on COPD exacerbations and patients were withdrawn from the studies if a severe exacerbation or more than 2 moderate exacerbations occurred.
Danish: De individuelle studier var ikke specifikt designet til at evaluere effekten af behandlinger af KOL-eksacerbationer, og patienter blev ekskluderet fra studierne, hvis der opstod en alvorlig eksacerbation eller flere end 2 moderate eksacerbationer.
English: It is very important to keep your inhaler clean so that medicine does not build-up and block the spray through the mouthpiece (See Figure 14).
Danish: Det er meget vigtigt at holde din inhalator ren, så medicinen ikke samler sig og blokerer sprayen gennem mundstykket (se figur 14).
English: Stop using Bevespi Aerosphere and seek immediate medical care if you notice any of the following symptoms:
Danish: Stop straks med at bruge Bevespi Aerosphere og søg omgående lægehjælp, hvis du bemærker nogle af følgende symptomer:
English: Figure 2d
Danish: Figur 2d
English: • Repeat the priming steps 3 more times (See Figure 4 and Figure 5).
Danish: • Gentag klargøringen 3 gange mere (se figur 4 og figur 5).
English: If paradoxical bronchospasm does occur, treatment with the medicinal product should be stopped and other treatments considered.
Danish: Hvis paradoks bronkospasme forekommer, bør behandling med lægemidlet seponeres og anden behandling overvejes.
English: How to use
Danish: Hvordan skal den bruges
English: Single-dose studies in humans found that very small amounts of glycopyrronium passed the placental barrier.
Danish: Enkeltdosis-studier hos mennesker viste, at meget små mængder af glycopyrronium passerede placenta-barrieren.
English: CYP2D6 and CYP2C have been identified as being primarily responsible for Odemethylation.
Danish: CYP2D6 og CYP2C er blevet identificeret som primært ansvarlige for O-demethylering.
English: The dose indicator display window shows how many puffs of medicine you have left.
Danish: Dosisindikatorvinduet viser hvor mange doser medicin, du har tilbage.
English: INNER CARTON, MULTIPACK - WITH NO BLUE BOX
Danish: INDRE KARTON, MULTIPAKNING - UDEN BLUE BOX
English: Based on literature, and an in-vitro human hepatocyte study, metabolism plays a minor role in the overall elimination of glycopyrronium.
Danish: Baseret på litteratur og et in vitro humant hepatocyt-studie spiller metabolismen en mindre rolle i den samlede eliminering af glycopyrronium.
English: It will only be effective as long as you are using it. Do not stop unless your doctor tells you to, even if you feel better, as your symptoms may get worse.
Danish: Stop ikke, medmindre din læge fortæller dig, at du skal, også selvom du føler dig bedre tilpas, da dine symptomer kan blive værre.
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Danish: Reduktion af serumkalium er typisk midlertidig og kræver ikke supplering.
English: Secondary metabolic pathways include deformylation and sulfate conjugation.
Danish: Sekundære metaboliske veje omfatter deformylering og sulfatkonjugering.
English: The active ingredients are present in a pressurised suspension inside the pressurised container.
Danish: De aktive ingredienser er indeholdt i en suspension under tryk i trykbeholderen.
English: In that study, 62% of the radiolabelled formoterol was excreted in the urine while 24% was eliminated in the faeces.
Danish: I det studie blev 62 % af den radioaktivt mærkede formoterol udskilt i urinen, mens 24 % blev udskilt i fæces.
English: • Carefully read the instructions for use in the patient information leaflet, which is packed together with each inhaler.
Danish: • Læs omhyggeligt brugsvejledningen i indlægssedlen, som er pakket sammen med hver inhalator.
English: Renal function was found not to affect exposure to formoterol.
Danish: Nyrefunktionen viste sig ikke at påvirke eksponeringen for formoterol.
English: • medicines that lower potassium in your blood.
Danish: • medicin, der nedsætter mængden af kalium i dit blod.
English: The inhaler can be used for up to 3 months after first opening the pouch.
Danish: Inhalatoren kan bruges i op til 3 måneder efter første åbning af posen.
English: • fast or irregular heart beat
Danish: • hurtig eller uregelmæssig puls
English: CARTON - SINGLE INHALER
Danish: KARTON - ENKEL INHALATOR
English: • Prime the inhaler by shaking it and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, has been exposed to low temperatures, or has been dropped.
Danish: • Klargør inhalatoren ved at ryste den og pumpe ud i luften fire gange før første anvendelse eller to gange, når inhalatoren ikke har været anvendt i mere end syv dage, har været udsat for lave temperaturer eller har været tabt.