FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiac disorders Common
Danish: Mave-tarm-kanalen Almindelig
English: Oedema peripheral Asthenia
Danish: Perifert ødem Asteni
English: Pulmonary function test decreased
Danish: Nedsatte resultater af lungefunktionsundersøgelser
English: Where at the 6-hour time point the ECG shows: New onset second-degree or higher AV block, or QTc interval ≥500 msec If pharmacological treatment is required, monitoring should be continued overnight and 6-hour monitoring should be repeated after the second dose.
Danish: Hvor EKG'et efter 6 timer viser: Nyopstået AV-blok af 2. grad eller derover eller QTc-interval ≥500 msek
English: - Patients with a history of second-degree Mobitz type II atrioventricular (AV) block, third-degree AV block, sino-atrial heart block or sick-sinus syndrome, if they do not wear a pacemaker (see section 4.4).
Danish: blok, sinoatrialt hjerteblok eller syg sinussyndrom, hvis de ikke anvender pacemaker (se pkt.
English: Poor metabolisers
Danish: Ekstremitetssmerter
English: • Perform liver function tests prior to initiating siponimod treatment.
Danish: • Før behandling med siponimod initieres, skal der udføres en leverfunktionsundersøgelse.
English: • Pregnancy Reminder Card for women of childbearing potential.
Danish: • Patientkort rettet specifikt mod graviditet til fertile kvinder.
English: Study month
Danish: Studiemåned
English: It must not be used by patients who:
Danish: Det må ikke anvendes af patienter, som:
English: • have or have had asthma;
Danish: • har eller har haft astma
English: • have certain heart problems;
Danish: • har bestemte hjerteproblemer
English: The suspension needs to be shaken well before use.
Danish: Suspensionen skal omrystes grundigt inden brug.
English: This is a summary of the European public assessment report (EPAR) for Azarga.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Azarga.
English: The European Commission granted a marketing authorisation valid throughout the EU for Azarga on 25 November 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Azarga den 25. november 2008.
English: The full EPAR for Azarga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Azarga findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: By lowering the pressure, Azarga reduces the risk of damage.
Danish: Ved at nedsætte trykket reducerer Azarga risikoen for skader.
English: • have severely reduced kidney function.
Danish: • har svært nedsat nyrefunktion.
English: IOP was measured in ‘millimetres of mercury' (mmHg).
Danish: IOP blev målt i "millimeter kviksølv" (mmHg).
English: Other information about Azarga
Danish: Andre oplysninger om Azarga
English: Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000.
Danish: Brinzolamid har været godkendt i EU som Azopt siden 2000.
English: In both studies, the main measure of effectiveness was the change in IOP over the first six months of treatment.
Danish: I begge undersøgelser var det primære mål for virkningen ændringen i IOP i løbet af de første seks måneders behandling.
English: A risk management plan has been developed to ensure that Azarga is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Azarga anvendes så sikkert som muligt.
English: The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
Danish: Kombinationen af de to aktive stoffer har en additiv virkning og sænker trykket inde i øjet mere end de enkelte lægemidler alene.
English: It is available as eye drops.
Danish: Det fås som øjendråber.
English: Azarga brinzolamide / timolol
Danish: Azarga brinzolamid/timolol
English: Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently.
Danish: Azarga anvendes, når behandling med et lægemiddel indeholdende kun ét aktivt stof har været forsøgt, men ikke har kunnet nedsætte IOP tilstrækkeligt.
English: The most common side effects with Azarga (seen in between 1 and 10 patients in 100) are blurred vision, eye pain and eye irritation.
Danish: De hyppigste bivirkninger ved Azarga (som optræder hos mellem 1 og 10 patienter ud af 100) er sløret syn, øjensmerter og øjenirritation.
English: If it is used with another eye medicine, the different medicines should be used at least 5 minutes apart.
Danish: Hvis det anvendes sammen med et andet øjemiddel, skal der gå mindst fem minutter mellem brugen af de forskellige lægemidler.
English: If the other eye medicine is an eye ointment it should be used last.
Danish: Er det andet øjemiddel en øjensalve, skal det anvendes til sidst.
English: What measures are being taken to ensure the safe and effective use of Azarga?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Azarga?
English: For more information about treatment with Azarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Azarga, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that combining the two active substances in Azarga simplifies therapy and helps patients to stick to their treatment.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) noterede sig, at kombinationen af de to aktive stoffer i Azarga gør behandlingen mere enkel og gør det lettere for patienterne at overholde behandlingen.
English: Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye).
Danish: Azarga anvendes til nedsættelse af det intraokulære tryk (IOP - væsketrykket i øjet).
English: Timolol is a beta blocker that has been commonly used to treat glaucoma since the 1970s.
Danish: Timolol er en betablokker, der har været almindeligt anvendt til behandling af glaukom siden 1970'erne.
English: It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal).
Danish: Det anvendes til voksne med åbenvinklet glaukom (en sygdom, hvor trykket i øjet stiger, fordi væsken ikke kan løbe ud af øjet) eller med okulær hypertension (hvor trykket i øjet er højere end normalt).
English: The two substances work by reducing the production of the aqueous humour (the watery fluid in the eye) in different ways.
Danish: De to stoffer virker ved at mindske produktionen af kammervæske (den vandige væske i øjet) på forskellige måder.
English: Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Danish: Forhøjet IOP medfører beskadigelse af nethinden (den lysfølsomme overflade bagest i øjet) og af synsnerven, der sender signalerne fra øjet til hjernen.
English: Azarga must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, other beta blockers (such as some heart medicines) or sulphonamides (an antibiotic).
Danish: Azarga må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for de aktive stoffer, andre af indholdsstofferne, andre betablokkere (såsom hjertemedicin) eller sulfonamider (et antibiotikum).
English: • have hyperchloraemic acidosis (excess acid in the blood caused by too much chloride);
Danish: • har hyperchloræmisk acidose (for højt syreindhold i blodet på grund af for meget klorid i blodet)
English: • have a severe allergic rhinitis (allergy affecting the nose and airways);
Danish: • har svær allergisk rhinitis (allergi, der påvirker næsen og luftvejene)
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Azarga.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Azarga skal anvendes.
English: Azarga has been studied in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension.
Danish: Azarga er blevet undersøgt i to hovedundersøgelser, der omfattede i alt 960 voksne med åbenvinket glaukom eller okulær hypertension.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Azarga, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Azarga, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide.
Danish: Azarga var mere effektivt end begge de aktive stoffer hver for sig og var lige så effektivt som kombinationen af timolol og dorzolamid.
English: Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body.
Danish: Brinzolamid er en hæmmer af karboanhydrase, som virker ved at blokere et enzym kaldet karboanhydrase, der producerer bikarbonationer i kroppen.
English: The Committee decided that Azarga's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede, at fordelene ved Azarga opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Azarga.
English: What is the risk associated with Azarga?
Danish: Hvilken risiko er der forbundet med Azarga?
English: Azarga is given as one drop into the affected eye(s) twice a day.
Danish: Azarga indgives som én dråbe i det/de berørte øje/øjne to gange dagligt.
English: This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol.
Danish: Dette tal var 5,1 til 5,6 mmHg hos de patienter, som fik brinzolamid, og 5,7 til 6,9 mmHg hos de patienter, som fik timolol.
English: The second was a 12-month study comparing Azarga with the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients.
Danish: Den anden var en 12-måneders undersøgelse, der havde til formål at sammenligne Azarga med kombinationen af timolol og dorzolamid (en anden hæmmer af karboanhydrase) hos 437 patienter.
English: In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga.
Danish: I den første undersøgelse faldt IOP fra ca. 21 mmHg med 8,0 til 8,7 mmHg hos de patienter, som fik Azarga.
English: Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses.
Danish: Azarga indeholder benzalkoniumchlorid, som vides at misfarve bløde kontaktlinser.
English: In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.
Danish: I den anden undersøgelse var IOP efter seks måneder faldet fra ca. 26 mmHg med ca. 8,3 mmHg i begge patientgrupper.
English: The first was a six-month study comparing Azarga with brinzolamide and with timolol used on their own in 523 patients.
Danish: Den første var en 6-måneders undersøgelse, der havde til formål at sammenligne Azarga med brinzolamid og med timolol alene hos 523 patienter.
English: • have severe chronic obstructive pulmonary disease (COPD, a disease causing narrowing of the airways);
Danish: • har svær kronisk obstruktiv lungesygdom (KOL, en sygdom, som forårsager forsnævring af luftvejene)
English: Why has Azarga been approved?
Danish: Hvorfor blev Azarga godkendt?
English: What is Azarga?
Danish: Hvad er Azarga?
English: For the full list of all side effects reported with Azarga, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Azarga fremgår af indlægssedlen.
English: Azarga is a medicine that contains two active substances, brinzolamide and timolol.
Danish: Azarga er et lægemiddel, der indeholder de to aktive stoffer brinzolamid og timolol.
English: Azarga contains two active substances, brinzolamide and timolol.
Danish: Azarga indeholder to aktive stoffer, nemlig brinzolamid og timolol.
English: What is Azarga used for?
Danish: Hvad anvendes Azarga til?
English: Bicarbonate is required for the production of the aqueous humour.
Danish: Kroppen kræver bikarbonat for at kunne producere kammervæsken.
English: How has Azarga been studied?
Danish: Hvordan blev Azarga undersøgt?
English: What benefit has Azarga shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Azarga?
English: How is Azarga used?
Danish: Hvordan anvendes Azarga?
English: How does Azarga work?
Danish: Hvordan virker Azarga?
English: This summary was last updated in 12-2008.
Danish: Dette sammendrag blev sidst ajourført i 12-2008.
English: The injection site is changed for each injection.
Danish: Der skiftes indstikssted for hver injektion.
English: This medicine is the same as Insuman, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Insuman, som allerede er godkendt i Den Europæiske Union.
English: The full list of these medicines is available in the Package Leaflet.
Danish: Den fuldstændige liste over disse lægemidler fremgår af indlægssedlen.
English: The patient's blood glucose should be tested regularly to find the lowest effective dose.
Danish: Patientens blodglukose skal kontrolleres regelmæssigt, så man kan finde den laveste dosis, der er effektiv.
English: The European Commission granted a marketing authorisation valid throughout the EU for Insulin Human Winthrop to Sanofi-Aventis Deutschland GmbH on 17 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Insulin Human Winthrop til Sanofi-Aventis Deutschland GmbH den 17. januar 2007.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose.
Danish: Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at regulere blodglukoseniveauet.
English: By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Danish: Ved at holde blodglukoseniveauet under kontrol mindskes sukkersygesymptomerne og -komplikationerne.
English: The desired blood glucose levels, the type of Insulin Human Winthrop to be used, and the dose and timing of injections are determined by the doctor for each patient individually, and are adjusted to suit the patient's diet, physical activity and lifestyle.
Danish: Det ønskede blodglukoseniveau, hvilken type Insulin Human Winthrop der skal anvendes, samt dosis og tidspunktet for injektionerne besluttes af lægen for den enkelte patient og tilpasses patientens diæt, fysiske aktivitet og livsstil.
English: Insulin Human Winthrop has been studied in two trials in 611 patients with either type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Danish: Insulin Human Winthrop er blevet undersøgt i to undersøgelser med 611 patienter, enten med type 1 diabetes (hvor kroppen ikke kan producere insulin) eller type 2 diabetes (hvor kroppen ikke kan udnytte insulinet effektivt).
English: Insulin Human Winthrop Rapid may also be given into a vein, but only in hospital where the patient can be closely monitored.
Danish: Insulin Human Winthrop Rapid kan desuden indgives i en vene, men kun i hospitalsomgivelser, hvor patienten kan overvåges nøje.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Insulin Human Winthrop's benefits are greater than its risks for the treatment of diabetes mellitus.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Insulin Human Winthrop er større end risiciene til behandling af sukkersyge (diabetes mellitus).
English: Insulin Human Winthrop was effective for both type 1 and type 2 diabetes.
Danish: Insulin Human Winthrop var effektivt til behandling af både type 1 og type 2 diabetes.
English: The active substance in Insulin Human Winthrop, insulin human, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin.
Danish: Det aktive stof i Insulin Human Winthrop, insulin human, produceres via en metode, der er kendt som ”rekombinant dna-teknologi”: det produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere insulin.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) INSULIN HUMAN WINTHROP RAPID INSULIN HUMAN WINTHROP BASAL INSULIN HUMAN WINTHROP COMB (15, 25, 30, 50) INSULIN HUMAN WINTHROP INFUSAT EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) INSULIN HUMAN WINTHROP RAPID INSULIN HUMAN WINTHROP BASAL INSULIN HUMAN WINTHROP COMB (15, 25, 30, 50) INSULIN HUMAN WINTHROP INFUSAT EPAR - sammendrag for offentligheden
English: Insulin Human Winthrop doses might need to be adjusted when it is given with other medicines that may have an effect on blood glucose levels.
Danish: Det kan være nødvendigt at justere Insulin Human Winthrop-doserne, når det gives sammen med andre lægemidler, der kan påvirke blodglukoseniveauet.
English: The studies measured the ‘fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours), or the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I undersøgelserne måltes det ”fastende” blodglukoseniveau (målt, når patienten ikke havde spist i mindst otte timer) eller koncentrationen af et stof i blodet kaldet glykosyleret hæmoglobin (HbA1c), der giver et fingerpeg om, hvor velreguleret blodglukosen er. I undersøgelserne måltes også antallet af patienter, som udviklede hypoglykæmi (lavt blodglukoseniveau).
English: Insulin Human Winthrop should not be used in people who may be hypersensitive (allergic) to insulin human or any of the other ingredients.
Danish: Insulin Human Winthrop må ikke anvendes hos personer, der kan være overfølsomme (allergiske) over for insulin human eller andre af indholdsstofferne.
English: Insulin Human Winthrop Rapid can also be used for the treatment of hyperglycaemic coma (coma caused by too much blood glucose [sugar]) and ketoacidosis (high levels of ketones [acids] in the blood), and to control blood glucose before, during or after an operation.
Danish: Insulin Human Winthrop Rapid kan desuden anvendes til behandling af hyperglykæmisk koma (bevidstløshed forårsaget af for høj blodglukose (blodsukker)) og ketoacidose (høje koncentrationer af ketoner [syrer] i blodet) samt til regulering af blodglukosen før, under og efter en operation.
English: The company that makes Insuman has agreed that its scientific data can be used for Insulin Human Winthrop.
Danish: Virksomheden, som fremstiller Insuman, har givet tilladelse til, at dens videnskabelige oplysninger må anvendes for Insulin Human Winthrop.
English: Insulin Human Winthrop led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with semi-synthetic human insulin.
Danish: Insulin Human Winthrop bevirkede et fald i indholdet af HbA1c som tegn på, at blodglukoseniveauet var blevet reguleret til et niveau svarende til det, der opnås med halvsyntetisk humant insulin.
English: In one of the studies, Insulin Human Winthrop was used in an insulin pump.
Danish: I den ene af undersøgelserne blev Insulin Human Winthrop anvendt i en insulinpumpe.
English: In the other study, Insulin Human Winthrop Comb 25 was compared with semi-synthetic human insulin.
Danish: I den anden undersøgelse blev Insulin Human Winthrop Comb 25 sammenlignet med halvsyntetisk humant insulin.
English: Insulin Human Winthrop is given by injection under the skin, generally in the abdominal wall (tummy) or the thigh, according to the doctor's recommendations.
Danish: Insulin Human Winthrop indgives ved injektion under huden, sædvanligvis i bugvæggen (maveskindet) eller i låret, som anbefalet af lægen.
English: It is supplied in vials, cartridges, or pre-filled disposable pens (OptiSet and SoloStar).
Danish: Det leveres i hætteglas, cylinderampuller og færdigfyldte injektionspenne til engangsbrug (OptiSet og SoloStar).
English: Insulin Human Winthrop contains the active substance insulin human.
Danish: Insulin Human Winthrop indeholder det aktive stof insulin human.
English: Insulin Human Winthrop can cause hypoglycaemia.
Danish: Insulin Human Winthrop kan medføre hypoglykæmi.
English: Insulin Human Winthrop is used in patients with diabetes who need treatment with insulin.
Danish: Insulin Human Winthrop anvendes til behandling af patienter med diabetes mellitus (sukkersyge), der har behov for behandling med insulin.
English: Insulin Human Winthrop contains insulin in various forms: the soluble form, which acts quickly (within 30 minutes of injection), and the isophane and crystallineprotamine forms, which are absorbed much more slowly during the day, giving them a longer duration of action.
Danish: Insulin Human Winthrop indeholder forskellige former for insulin: den opløselige form, der er hurtigtvirkende (inden for 30 minutter efter injektion), og "isophan"- og krystallinske protaminformer, der optages meget langsommere dagen igennem, hvorved de virker længere.
English: The Insulin Human Winthrop range is comprised of fast-acting insulin solutions (Insulin Human Winthrop Rapid and Insulin Human Winthrop Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insulin Human Winthrop Basal) that contains isophane insulin, and combinations of fast- and intermediateacting in various proportions (Insulin Human Winthrop Comb):
Danish: Insulin Human Winthrop-serien består af hurtigtvirkende insulinopløsninger (Insulin Human Winthrop Rapid og Insulin Human Winthrop Infusat), der indeholder opløseligt insulin, en middellangt virkende insulinsuspension (Insulin Human Winthrop Basal), der indeholder isophaninsulin, og kombinationer af hurtigt- og middelangtvirkende insulin i forskellige blandingsforhold (Insulin Human Winthrop Comb):
English: Insulin Human Winthrop is a replacement insulin that is identical to the insulin made by the body.
Danish: Insulin Human Winthrop er et erstatningsinsulin, der er identisk med det insulin, der produceres af kroppen.
English: The full EPAR for Insulin Human Winthrop is available here.
Danish: Den fuldstændige EPAR for Insulin Human Winthrop findes her.
English: Other information about Insulin Human Winthrop:
Danish: Andre oplysninger om Insulin Human Winthrop:
English: Insulin Human Winthrop is a range of insulin solutions and suspensions for injection.
Danish: Insulin Human Winthrop er en række forskellige opløsninger og suspensioner af insulin til injektion.
English: Insulin Human Winthrop Infusat is specially prepared ready to be used in infusion pumps.
Danish: Insulin Human Winthrop Infusat er specielt fremstillet til anvendelse i infusionspumper.
English: For the full list of all side effects reported with Insulin Human Winthrop, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Insulin Human Winthrop fremgår af indlægssedlen.
English: The Committee recommended that Insulin Human Winthrop be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Insulin Human Winthrop.
English: Why has Insulin Human Winthrop been approved?
Danish: Hvorfor blev Insulin Human Winthrop godkendt?