FrancophonIA/ELRC3.0 huggingface dataset:
English: Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.http://www.bloodjournal.org/content/121/20/4046.full.pdf study, the FranceCoag study also found no statistically significant increased risk for any rFVIII products vs Advate when French patients (also in the RODIN/Pednet study) were excluded.
Danish: Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.http://www.bloodjournal.org/content/121/20/4046.full.pdf højtiter-) for 2. generations rFVIII octocog alfa (Kogenate FS/Helixate NexGen) end for 3. generations rFVIII octocog alfa (dette skyldtes udelukkende data for Advate).
English: Special populations
Danish: Specielle populationer Pædiatrisk population
English: Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 mL/h.Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 mL/h corresponding to 3.0 mL/h/kg (range 1.6-4.6 mL/h/kg).
Danish: Yderligere farmakokinetiske parametre for Helixate NexGen til bolusindgift er: en mean residence time [MRT (0 - 48)] på omkring 22 timer og en clerance på omkring 160 ml/time.
English: Determine the point of injection and clean the skin with an alcohol swab.
Danish: Bestem indstikssted og rengør dette med en antiseptisk swab.
English: If your or your child's bleeding is not being controlled with Helixate NexGen, tell your doctor immediately.
Danish: Fortæl det straks til lægen, hvis din eller dit barns blødning ikke holdes under kontrol med Helixate NexGen.
English: With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew counter clockwise the set carefully into two pieces.
Danish: Tag med den ene hånd fat i den del af Mix2Vial-sættet, hvor pulverhætteglasset sidder, og tag med den anden hånd fat i den del, hvor vandhætteglasset sidder, og skru forsigtigt sættet fra hinanden.
English: Helixate NexGen 250 IU powder and solvent for solution for injection Helixate NexGen 500 IU powder and solvent for solution for injection Helixate NexGen 1000 IU powder and solvent for solution for injection Helixate NexGen 2000 IU powder and solvent for solution for injection Helixate NexGen 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Danish: Helixate NexGen 250 IE pulver og solvens til injektionsvæske, opløsning Helixate NexGen 500 IE pulver og solvens til injektionsvæske, opløsning Helixate NexGen 1000 IE pulver og solvens til injektionsvæske, opløsning Helixate NexGen 2000 IE pulver og solvens til injektionsvæske, opløsning Helixate NexGen 3000 IE pulver og solvens til injektionsvæske, opløsning Rekombinant koagulationsfaktor VIII (octocog alfa)
English: What Helixate NexGen is and what it is used for What you need to know before you use Helixate NexGen How to use Helixate NexGen Possible side effects
Danish: Det skal du vide, før du begynder at bruge Helixate NexGen Sådan skal du bruge Helixate NexGen Bivirkninger
English: Helixate NexGen 250 IU powder and solvent for solution for injection Helixate NexGen 500 IU powder and solvent for solution for injection Helixate NexGen 1000 IU powder and solvent for solution for injection Helixate NexGen 2000 IU powder and solvent for solution for injection Helixate NexGen 3000 IU powder and solvent for solution for injection
Danish: Helixate NexGen 250 IE pulver og solvens til injektionsvæske, opløsning Helixate NexGen 500 IE pulver og solvens til injektionsvæske, opløsning Helixate NexGen 1000 IE pulver og solvens til injektionsvæske, opløsning Helixate NexGen 2000 IE pulver og solvens til injektionsvæske, opløsning Helixate NexGen 3000 IE pulver og solvens til injektionsvæske, opløsning
English: Detailed instructions for reconstitution and administration of Helixate NexGen using the Mix2Vial adapter:
Danish: Detaljerede instruktioner om opløsning og indgift af Helixate:
English: Finally, apply a small pressure dressing to the injection site and consider if a plaster is necessary.
Danish: Til slut lægges en lille kompressionsforbinding på såret.
English: Helixate NexGen 250 IU powder for solution for injection Helixate NexGen 500 IU powder for solution for injection Helixate NexGen 1000 IU powder for solution for injection Helixate NexGen 2000 IU powder for solution for injection Helixate NexGen 3000 IU powder for solution for injection
Danish: Helixate NexGen 250 IE pulver til injektionsvæske, opløsning Helixate NexGen 500 IE pulver til injektionsvæske, opløsning Helixate NexGen 1000 IE pulver til injektionsvæske, opløsning Helixate NexGen 2000 IE pulver til injektionsvæske, opløsning Helixate NexGen 3000 IE pulver til injektionsvæske, opløsning
English: 250 IU (octocog alfa) (100 IU/mL after reconstitution).
Danish: 250 IE octocog alfa (100 IE/ml efter opløsning).
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting by screwing clockwise.
Danish: Hold pulverhætteglasset lodret og skru sprøjten på Mix2Vial-sættet Luer-lås.
English: 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
Danish: 3000 IE octocog alfa (600 IE/ml efter opløsning).
English: 500 IU (octocog alfa) (200 IU/mL after reconstitution).
Danish: 500 IE octocog alfa (200 IE/ml efter opløsning).
English: 2000 IU (octocog alfa) (400 IU/mL after reconstitution).
Danish: 2000 IE octocog alfa (400 IE/ml efter opløsning).
English: How to use Helixate NexGen
Danish: Sådan skal du bruge Helixate NexGen
English: 1000 IU (octocog alfa) (400 IU/mL after reconstitution).
Danish: 1000 IE octocog alfa (400 IE/ml efter opløsning).
English: • One mL Helixate NexGen 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Danish: • 1 ml Helixate NexGen 250 IE indeholder ca. 100 IE (250 IE / 2,5 ml) human koagulationsfaktorVIII (INN: octocog alfa) efter rekonstitution.
English: • One mL Helixate NexGen 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Danish: • 1 ml Helixate NexGen 3000 IE indeholder ca. 600 IE (3000 IE / 5 ml) human koagulationsfaktorVIII (INN: octocog alfa) efter rekonstitution.
English: • One mL Helixate NexGen 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Danish: • 1 ml Helixate NexGen 1000 IE indeholder ca. 400 IE (1000 IE / 2,5 ml) human koagulationsfaktorVIII (INN: octocog alfa) efter rekonstitution.
English: • One mL Helixate NexGen 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Danish: • 1 ml Helixate NexGen 2000 IE indeholder ca. 400 IE (2000 IE / 5 ml) human koagulationsfaktorVIII (INN: octocog alfa) efter rekonstitution.
English: • One mL Helixate NexGen 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Danish: • 1 ml Helixate NexGen 500 IE indeholder ca. 200 IE (500 IE / 2,5 ml) human koagulationsfaktorVIII (INN: octocog alfa) efter rekonstitution.
English: How Helixate NexGen is given
Danish: Sådan forberedes Helixate NexGen til anvendelse
English: However, please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Enyglid is taken before meals, normally up to 15 minutes before each main meal.
Danish: Enyglid tages inden et måltid, normalt op til 15 minutter inden hvert hovedmåltid.
English: Enyglid repaglinide
Danish: Enyglid repaglinid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Enyglid on 14 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Enyglid den 14. oktober 2009.
English: The full EPAR for Enyglid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Enyglid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Enyglid.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Enyglid.
English: Other information about Enyglid
Danish: Andre oplysninger om Enyglid
English: What are the benefits and risks of Enyglid?
Danish: Hvilken fordel og risiko er der forbundet med Enyglid?
English: Enyglid is a ‘generic medicine'.
Danish: Enyglid er et »generisk lægemiddel«.
English: It is available as tablets (0.5, 1 and 2 mg).
Danish: Det fås som tabletter (0,5 mg, 1 mg og 2 mg).
English: This means that Enyglid is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
Danish: Det betyder, at Enyglid er identisk med et »referencelægemiddel«, som allerede er godkendt i Den Europæiske Union (EU), og som hedder NovoNorm.
English: For more information about treatment with Enyglid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Enyglid, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Enyglid.
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 Enyglid skal anvendes.
English: If patients are transferred from another diabetes medicine, the recommended starting dose is 1 mg.
Danish: Hvis patienten er skiftet fra et andet diabeteslægemiddel, er den anbefalede startdosis 1 mg.
English: The Committee recommended that Enyglid be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Enyglid.
English: Enyglid is a diabetes medicine that contains the active substance repaglinide.
Danish: Enyglid er et diabeteslægemiddel, der indeholder det aktive stof repaglinid.
English: The CHMP concluded that, in accordance with EU requirements, Enyglid has been shown to have comparable quality and to be bioequivalent to NovoNorm.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Enyglid er af sammenlignelig kvalitet og er bioækvivalent med NovoNorm.
English: What is Enyglid?
Danish: Hvad er Enyglid?
English: Why has Enyglid been approved?
Danish: Hvorfor blev Enyglid godkendt?
English: Because Enyglid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Danish: Da Enyglid er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) is not adequately controlled by diet, weight reduction and exercise.
Danish: Det anvendes sammen med diæt og motion til at sænke niveauet af blodglukose (sukker) hos patienter, hvis hyperglykæmi (højt blodglukoseniveau) ikke kan kontrolleres tilstrækkeligt med diæt, vægttab og motion.
English: Enyglid is used in adults who have type 2 diabetes.
Danish: Enyglid anvendes hos voksne, som lider af type 2-diabetes.
English: Therefore, the CHMP's view was that, as for NovoNorm, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for NovoNorm.
English: Enyglid helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Danish: Enyglid får bugspytkirtlen til at producere mere insulin i forbindelse med måltider og anvendes til behandling af type 2- diabetes.
English: Enyglid may also be used with metformin (another diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Danish: Enyglid kan også anvendes i kombination med metformin (et andet diabeteslægemiddel) til patienter med type 2diabetes, hvis glukoseniveau ikke er tilstrækkeligt kontrolleret med metformin alene.
English: Because Enyglid is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, NovoNorm.
Danish: Da Enyglid er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet NovoNorm.
English: What is Enyglid used for?
Danish: Hvad anvendes Enyglid til?
English: How has Enyglid been studied?
Danish: Hvordan blev Enyglid undersøgt?
English: How is Enyglid used?
Danish: Hvordan anvendes Enyglid?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom hvis blodglukoseniveau normalt kontrolleres tilfredsstillende med diæt, men hvor blodglukosen midlertidigt ikke er under kontrol.
English: These effects are mild and temporary.
Danish: Disse bivirkninger er lette og forbigående.
English: The marketing authorisation was renewed on 13 June 2005.
Danish: Denne tilladelse blev fornyet den 13 juni 2005.
English: Ibaflin is given by mouth.
Danish: Ibaflin gives gennem munden.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CVMP's anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
English: Ibaflin is available as tablets (30, 150, 300 and 900 mg) and as oral gels (3 and 7.5%).
Danish: Ibaflin leveres som tabletter (30, 150, 300 og 900 mg) og som oral gel (3 og 7,5 %).
English: Other information about Ibaflin:
Danish: Andre oplysninger om Ibaflin:
English: Cats are treated using the 3% oral gel.
Danish: Katte behandles med oral gel, 3 %.
English: The standard dose is 15 mg per kilogram body weight once a day for the length of time determined by your veterinarian.
Danish: Standarddosis er 15 mg pr. kg legemsvægt én gang dagligt.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IBAFLIN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) IBAFLIN EPAR - sammendrag for offentligheden
English: People who are hypersensitive (allergic) to quinolones should avoid any contact with Ibaflin.
Danish: Personer, der er overfølsomme (allergiske) over for quinoloner, bør undgå kontakt med Ibaflin.
English: This enzyme is only found in bacterial cells, and does not have a similar function in animal cells.
Danish: Enzymet findes kun i bakterieceller og har ikke en tilsvarende funktion i dyreceller.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ibaflin to Intervet International B.V. on 13 June 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ibaflin til Intervet International B.V.
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelser for produktet findes på etiketten/kartonen.
English: The dose and duration of treatment depend on the nature and severity of the infection, the weight and species of the animal being treated, and the animal's response to treatment.
Danish: Dosis og behandlingsvarighed afhænger af betændelsens art og sværhed, det behandlede dyrs vægt og art samt behandlingens virkning.
English: Why has Ibaflin been approved?
Danish: Hvorfor blev Ibaflin godkendt?
English: By blocking DNA gyrase, ibafloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Danish: Ved at blokere dna-gyrase forhindrer ibafloxacin bakterierne i at producere dna og standser deres proteinproduktion og vækst, så de dør.
English: Ibaflin is used to treat the infections in dogs and cats:
Danish: Ibaflin anvendes til behandling af infektioner hos hunde og katte:
English: The use of ibafloxacin may result in an increase in the prevalence of resistant strains in the target species although this risk is likely to be less of a concern due to the treatment of individual animals with this product.
Danish: Anvendelse af ibafloxacin kan føre til øget forekomst af resistente stammer, men dette skulle ikke give grund til særlig betænkelighed, da produktet anvendes til behandling af individuelle dyr.
English: Dogs are treated using the tablets, except for skin infection, where in addition to the tablets either strengths of the oral gel may be used.
Danish: Til hunde anvendes tabletter, dog bortset fra hudinfektioner, hvor der ud over tabletterne kan anvendes en af de to styrker af den orale gel.
English: It works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Danish: Det virker ved at blokere enzymet dna-gyrase, der er vigtigt for bakterierne, da det gør dem i stand til at kopiere deres dna.
English: What is Ibaflin?
Danish: Hvad er Ibaflin?
English: Medical advice should be sought if the tablets are swallowed accidentally, particularly by a child.
Danish: Ved utilsigtet indtagelse af tabletterne bør der søges lægehjælp, navnlig hvis der tale om et barn.
English: In these studies, the effects of Ibaflin were compared with those of other antibiotics (marbofloxacin, enrofloxacin or amoxicillin/clavulanic acid).
Danish: I undersøgelserne blev virkningerne af Ibaflin sammenlignet med virkningerne af andre antibiotika (marbofloxacin, enrofloxacin og amoxicillin/clavulansyre).
English: Ibaflin contains ibafloxacin, which belongs to a class of medicines having an antibiotic action.
Danish: Ibaflin indeholder ibafloxacin, der tilhører en klasse lægemidler med antibiotisk virkning.
English: Diarrhoea, soft faeces, vomiting, dullness (lack of responsiveness) and anorexia (loss of appetite) occur with low frequency in dogs and cats given Ibaflin.
Danish: Diarré, blød afføring, opkastning, sløvhed (manglende interesse) og manglende ædelyst forekommer med lav hyppighed hos hunde og katte, der får Ibaflin.
English: What are the side-effects associated with Ibaflin?
Danish: Hvilke bivirkninger er forbundet med Ibaflin?
English: A strain which is resistant to one type of fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
Danish: Hvis en bakteriestamme er resistent over for ét fluorquinolon, vil den også være resistent over for andre stoffer i gruppen af fluorquinoloner.
English: • upper respiratory tract infections caused by Staphylococci, E. coli and Klebsiella species.
Danish: • øvre luftvejsinfektioner forårsaget af Staphylococci, E. coli og Klebsiella.
English: The indication for treatment of urinary infections in cats was not accepted.
Danish: Produktet blev ikke godkendt til behandling af urinvejsinfektioner hos katte.
English: • skin infections, including shallow and deep ‘pyoderma', infected wounds and abscesses caused by bacteria such as Staphylococci, E. coli, Proteus species and Pasteurella species,
Danish: • hudinfektioner, herunder overfladiske og dybe pusdannende hudinfektioner, inficerede sår og bylder forårsaget af bakterier som Staphylococci, E. coli, Proteus og Pasteurella,
English: It is also used in dogs to treat acute (short-lived), uncomplicated infections of the urinary tract caused by Staphylococci, Proteus species, Enterobacter species, E. coli and Klebsiella species.
Danish: Det anvendes desuden hos hunde til behandling af akut (kortvarig), ukompliceret urinvejsbetændelse forårsaget af Staphylococci, Proteus, Enterobacter, E. coli og Klebsiella.
English: What is Ibaflin used for?
Danish: Hvad anvendes Ibaflin til?
English: How has Ibaflin been studied?
Danish: Hvordan blev Ibaflin undersøgt?
English: Ibafloxacin, is an antibiotic belonging to the class ‘fluoroquinolones'.
Danish: Ibafloxacin er et antibiotikum tilhørende gruppen af fluorquinoloner.
English: What benefit has Ibaflin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Ibaflin?
English: The tablets and oral gel were of comparable effectiveness in treating skin infections in dogs.
Danish: Tabletterne og den orale gel var lige effektive til behandling af hudinfektioner hos hunde.
English: The oral gel was also at least as effective as the comparator antibiotic (amoxicillin/clavulanic acid) in treating skin and upper respiratory tract infections in cats.
Danish: Den orale gel var også mindst lige så effektiv som sammenligningsprodukterne (amoxicillin/clavulansyre) til behandling af hud- og øvre luftvejsinfektioner hos katte.
English: Ibaflin oral gel is indicated in dogs for the treatment of skin infections (pyoderma - superficial and deep, wounds, abscesses).
Danish: Ibaflin oral gel kan anvendes til behandling af hudinfektioner hos hunde (pusdannende infektioner - overfladiske og dybe, sår, bylder).
English: Salivation can also occur with the oral gel.
Danish: Den orale gel kan desuden give spytflåd.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ibaflin exceed the risks for the treatment of skin infections, and respiratory tract infections (upper tract) in dogs and cats, and acute, uncomplicated urinary tract infections in dogs, and recommended that Ibaflin be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Ibaflin opvejer risiciene til behandling af hudinfektioner og øvre luftvejsinfektioner hos hunde og katte samt akutte, ukomplicerede urinvejsinfektioner hos hunde.
English: Ibaflin tablets have been studied in dogs, looking at their effectiveness in treating skin, urinary tract and respiratory tract infections.
Danish: Ibaflin tabletter blev undersøgt hos hunde med henblik på behandling af hud-, urinvejs- og luftvejsinfektioner.
English: The oral gel has been studied in cats looking at skin, respiratory tract and urinary tract infections.
Danish: Den orale gel blev undersøgt hos katte til behandling af hud-, luftvejs- og urinvejsinfektioner.
English: Ibaflin tablets were at least as effective as the comparator antibiotics in treating skin, urinary tract and upper tract respiratory infections in dogs.
Danish: Ibaflin i tabletform var mindst lige så effektivt som de antibiotika, det blev sammenlignet med, til behandling af hud-, urinvejs- og øvre luftvejsinfektioner hos hunde.
English: How does Ibaflin work?
Danish: Hvordan virker Ibaflin?
English: From data of two different clinical trials, comparable efficacy was shown between the Ibaflin gel formulations and a positive control to support the claims for skin (soft tissue infections - wounds, abscesses) and upper respiratory tract infections in cats for the oral gel formulations.
Danish: Resultaterne underbyggede, at de orale geler kan anvendes hos katte til behandling af hudinfektioner (bløddelsinfektioner - sår, bylder) og øvre luftvejsinfektioner.
English: However, the results were insufficient to support the use of Ibaflin in the treatment of urinary tract infections in cats.
Danish: Til urinvejsinfektioner hos katte var resultaterne for Ibaflin imidlertid utilstrækkelige til, at denne anvendelse kan godkendes.