FrancophonIA/ELRC3.0 huggingface dataset:
English: Distribution: Following oral administration, tilmicosin is distributed throughout the body with especially high levels found in lungs.
Danish: Fordeling: Efter oral indgift fordeles tilmicosin i hele kroppen med særligt høje niveauer fundet i lungerne.
English: Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended
Danish: På grund af sandsynligheden for variabilitet (tid, sted) i forekomsten af bakterieresistens over for tilmicosin anbefales det at tage bakteriologiske prøver og følsomhedstest.
English: The CVMP has assessed a PK/PD approach to support use in respiratory disease in rabbit and one clinical trial, as well as bibliographic and pharmacovigilance data provided by the
Danish: CVMP har vurderet en farmakokinetisk/farmakodynamisk indfaldsvinkel til støtte af anvendelse til luftvejssygdomme hos kaniner og én klinisk undersøgelse såvel som bibliografiske oplysninger og oplysninger vedrørende lægemiddelovervågning fra indehaverne af markedsføringstilladelserne.
English: The highest concentration in the serum (0.23 ±0.08 µg/ml) was recorded on day 10 of medication, but concentrations above the limit of quantification (0.10 µg/ml) were not found in 3 out of 20 animals examined.
Danish: Den højeste serumkoncentration (0,23 ± 0,08 µg/ml) blev registreret efter 10 dages medicinering, men der blev ikke registreret koncentrationer over kvantificeringsgrænsen (0,10 µg/ml) hos 3 ud af 20 undersøgte dyr.
English: - In the case of accidental ingestion, wash out mouth immediately with water and seek medical advice.
Danish: - Ved utilsigtet indtagelse af lægemidlet, skyl straks munden med vand og søg læge.
English: A preformed block bottomed 1 kg bag constructed using a paper/polyethylene/aluminium/polyethylene/paper laminate either stitched closed or heat-sealed Not all pack sizes may be marketed.
Danish: En 1-kg-pose med fast firkantet bund konstrueret ved at anvende et papir/polyethylen/aluminium/polyethylen/papir-laminat, som enten er syet sammen eller varmeforseglet.
English: PHARMACEUTICAL FORM Premix for medicated feeding stuff.
Danish: LÆGEMIDDELFORM Premix til medicineret foder.
English: In conclusion, the recommended shelf life after incorporation into meal or pelleted feed for both target species is 1 month.
Danish: Den anbefalede opbevaringstid efter opblanding i fodermel eller foderpiller for begge målarter er således 1 måned.
English: Pigs: Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae.
Danish: Svin: Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae.
English: Efficacy in rabbits
Danish: Virkning hos kaniner
English: Elimination: Following oral administration, tilmicosin is excreted mainly via the bile into the faeces but a small proportion is excreted via the urine.
Danish: Eliminering: Efter oral indgift udskilles tilmicosin overvejende via galden til fæces, mens en mindre mængde udskilles via urinen.
English: When administered at a dose of 200 mg tilmicosin/kg feed (equivalent to approximately 11.0 mg/kg/day), plasma concentrations above the limit of quantification (0.10 µg/ml) were found in 3 out of 20 animals examined.
Danish: Ved indgift ved en dosis på 200 mg tilmicosin/kg foder (svarende til cirka 11,0 mg/kg/dag) blev der fundet plasmakoncentrationer over kvantificeringsgrænsen (0,10 µg/ml) hos 3 ud af 20 undersøgte dyr.
English: After 5 days of treatment with medicated feed at a dosage of 200 ppm of Pulmotil, tilmicosin concentrations in lung tissues were of 192 ± 103 µg/g.
Danish: Efter behandling med medicineret foder ved en dosis på 200 ppm Pulmotil i 5 dage, var koncentrationen af tilmicosin i lungevæv 192 ± 103 µg/g.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Danish: EVENTUELLE SÆRLIGE FORSIGTIGHEDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALDSMATERIALER FRA SÅDANNE
English: The maximum concentration in lung tissue (2.59±1.01 µg/ml) was recorded on day 10 of medication.
Danish: Den højeste koncentration i lungevæv (2,59 ± 1,01 µg/ml) blev opnået efter 10 dages medicinering.
English: 8-16 mg/kg bodyweight/day
Danish: 8-16 mg/kg kropsvægt/dag
English: • Include a new statement in relation to the prudent use: due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended;
Danish: • Der medtages en ny erklæring om forsigtig brug: Da forekomsten af bakterieresistens over for tilmicosin sandsynligvis varierer (tidsmæssigt og geografisk), anbefales det, at der foretages bakteriologiske prøver og følsomhedsbestemmelse.
English: Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin related substances.
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr Ukorrekt brug af lægemidlet kan øge forekomsten af bakterier, der er resistente over for tilmicosin, og kan reducere effektiviteten af behandlingen med tilmicosin-lignende stoffer.
English: For products containing 200g tilmicosin/kg:
Danish: For produkter indeholdende 200 g tilmicosin/kg:
English: the CVMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names.
Danish: anbefalede CVMP, at de markedsføringstilladelser for Pulmotil 40 Vet. premix, Pulmotil 100 Vet. premix, Pulmotil 200 Vet. premix og tilknyttede navne ændres.
English: Therefore, to protect soil and ground water, pig manure not to be spread onto the grass land and when spread onto arable land plough to a depth of 30 cm. Environmental assessments have demonstrated that the use of Pulmotil Premix as indicated is not expected to have any impact on the environment.
Danish: For at beskytte jord og grundvand undgå derfor at sprede gødningsstof fra svin på jord med græs og pløj til en dybde på 30 cm ved spredning på dyrkningsarealer.
English: In respect of the benefit/risk balance for target species rabbit, the CVMP considers that benefit/risk balance is positive: - notwithstanding the fact that the clinical field study using dosage of the product have some shortcomings, the pre-clinical studies and the recent MICs data suggest the effective dosage in feed is 12.5 mg/kg for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in rabbits; - rabbit is minor species, with specific problems on availability of authorised veterinary products; - the history of use and the various management steps now set out in the harmonised SPC (bacteriological sampling and susceptibility testing are recommended).
Danish: Med hensyn til benefit/risk-forholdet for kaniner som målart vurderer CVMP, at benefit/risk-forholdet er positivt: - Til trods for visse mangler i forbindelse med den anvendte dosis af lægemidlet i den kliniske feltundersøgelse antyder de prækliniske undersøgelser og de nye MIC-data, at den effektive dosis i foder er 12,5 mg/kg i 7 dage ved forebyggelse og behandling af luftvejssygdomme forårsaget af Pasteurella multocida og Bordetella bronchiseptica hos kaniner.
English: The CVMP accepts that a claim for efficacy at a dose of 8 to 16 mg/kg bw/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days for prevention and treatment of respiratory infections in pigs has been demonstrated.
Danish: CVMP accepterer, at en påstand om virkning ved en dosis på 8-16 mg/kg kropsvægt/dag af tilmicosin (svarende til 200-400 ppm i foderet) i 15-21 dage til forebyggelse og behandling af luftvejsinfektioner hos svin er blevet påvist.
English: 12 mg/kg bodyweight/day
Danish: 12 mg/kg kropsvægt/dag
English: Product containing 200g tilmicosin/kg is packed in either:
Danish: Produkter indeholdende 200 g tilmicosin/kg er pakket i enten:
English: SPC harmonisation
Danish: Harmonisering af produktresuméet
English: Paper/polyethylene/aluminium/polyethylene/paper bags containing 2 kg, 5 kg or 10 kg of product.
Danish: Papir/polyethylen/aluminium/polyethylen/papir-poser med 2 kg, 5 kg eller 10 kg produkt.
English: Shelf life after first opening the immediate packaging: 3 months is not included in the Marketing Authorisation Holders' proposal, but it is part of the marketing authorisation in 3 Member States.
Danish: Dette er ikke en del af forslaget fra indehaverne af markedsføringstilladelserne, men indgår i markedsføringstilladelsen i tre medlemsstater.
English: Absorption: When administered to pigs via the oral route at a dose of 400 mg tilmicosin/kg feed (equivalent to approximately 21.3 mg tilmicosin/kg bodyweight/day), tilmicosin moves rapidly out of the serum into areas of low pH.
Danish: Absorption: Ved peroral indgivelse til svin af 400 mg tilmicosin/kg foder (svarende til cirka 21,3 mg tilmicosin/kg kropsvægt/dag) opnås hurtigt en lav serumkoncentration, men højere koncentrationer i væv, der har en lavere pH.
English: • The shelf life after incorporation into meal or pelleted feed: 1 month;
Danish: • Opbevaringstid efter opblanding i fodermel eller foderpiller: 1 måned.
English: MARKETING AUTHORISATION NUMBER(S) {For national implementation}
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) {Til national gennemførelse}
English: Pigs, Rabbits
Danish: Svin, kaniner
English: Pharmaceutical form Strength
Danish: Lægemiddelform
English: A yellowish tan to reddish tan free-flowing granular material.
Danish: Et gulbrunt til rødbrunt fritflydende kornet materiale.
English: Under practical conditions, the management of respiratory disease outbreaks recognises that acutely ill animals are inappetant and require parenteral therapy.
Danish: 4.4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til I praksis erkendes det, at akut syge dyr ingen appetit har, og at behandling af udbrud af luftvejsinfektion derfor kræver parenteral behandling.
English: MARKETING AUTHORISATION HOLDER {For national implementation}
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN {Til national gennemførelse}
English: b) The amounts to be administered and administration route: administered in the feed at 12 mg/kg bodyweight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Danish: b) Dosering og indgivelsesvej: indgives i foderet i en dosis på 12 mg/kg kropsvægt/dag af tilmicosin (svarende til 200 ppm i foderet) i 7 dage.
English: The following indication can be accepted: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin in pigs.
Danish: Følgende indikation kan godkendes: Forebyggelse og behandling af luftvejssygdomme forårsaget af Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida og andre tilmicosin-følsomme organismer hos svin.
English: Rabbits: Prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Danish: Kaniner: Forebyggelse og behandling af luftvejsinfektion forårsaget af Pasteurella multocida og Bordetella bronchiseptica, som er følsomme over for tilmicosin.
English: Pigs Rabbits
Danish: Svin Kaniner
English: Polyethylene/polyamide/polyethylene (inner layer) bag containing 10 kg of product, or, 2.
Danish: Polyethylen/polyamid/polyethylen (indvendigt lag) pose med 10 kg produkt, eller 2.
English: Fattening pigs
Danish: Svin til opfedning
English: Shelf life after incorporation into meal or pelleted feed: 1 month.
Danish: Opbevaringstid efter opblanding i fodermel eller foderpiller: 1 måned.
English: Do not use in case of hypersensitivity to tilmicosin or to any of the excipients 4.4 Special warnings for each target species
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for tilmicosin eller et eller flere af hjælpestofferne.
English: Distribution: Following oral administration, tilmicosin is distributed throughout the body with especially high levels found in the lung and in lung tissue macrophages.
Danish: Fordeling: Efter peroral indgift fordeles tilmicosin overalt i kroppen, men særligt høje niveauer findes i lungerne og i lungevævsmakrofager.
English: Polyethylene/polyamide/polyethylene (inner layer) bags containing 10 kg of product, or, 2.
Danish: Polyethylen/polyamid/polyethylen (indvendigt lag) poser med 10 kg produkt eller 2.
English: a) The indication for use in rabbits: prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica susceptible to tilmicosin.
Danish: a) Terapeutiske indikationer hos kaniner: forebyggelse og behandling af luftvejssygdomme forårsaget af tilmicosin-følsom Pasteurella multocida og Bordetella bronchiseptica.
English: Administer in the feed at a dose of 8 to 16 mg/kg body weight/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days.
Danish: Giv iblandet foder ved en dosis på 8 til 16 mg/kg kropsvægt/dag af tilmicosin (svarende til 200 til 400 ppm i foderet) i en periode på 15 til 21 dage.
English: Administer in the feed at 12 mg/kg body weight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Danish: Giv iblandet foder ved en dosis på 12 mg/kg kropsvægt/dag af tilmicosin (svarende til 200 ppm i foderet) i 7 dage.
English: Pigs: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Danish: Svin: Forebyggelse og behandling af luftvejsinfektion forårsaget af Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida og andre organismer, som er følsomme over for tilmicosin.
English: 2 kg Pulmotil 100Vet Premix/tonne
Danish: 2 kg Pulmotil 100Vet premix/ton
English: 5-10 kg Pulmotil 40 Vet Premix/tonne
Danish: 5-10 kg Pulmotil 40 Vet premix/ton
English: In case of accidental ingestion seek medical advice immediately and show the label to the physician.
Danish: Der bør bæres personligt beskyttelsesudstyr Ved utilsigtet indtagelse skal der straks søges lægehjælp, og etiketten skal vises til lægen.
English: 5kg Pulmotil 40 Vet Premix /tonne
Danish: 5 kg Pulmotil 40 Vet premix/ton
English: 2-4 kg Pulmotil 100 Vet Premix /tonne
Danish: 2-4 kg Pulmotil 100 Vet premix/ton
English: Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52-Bte Stoofstraat 52
Danish: Elanco Animal Health Rue de l'Etuve 52-Bte Stoofstraat 52
English: 1 kg Pulmotil 200 Vet Premix /tonne
Danish: 1 kg Pulmotil 200 Vet premix/ton
English: 40 g tilmicosin per 1000 g Member State Marketing Authorisation Holder
Danish: 40 g tilmicosin pr. 1000 g
English: 1-2 kg Pulmotil 200 Vet Premix /tonne
Danish: 1-2 kg Pulmotil 200 Vet premix/ton
English: 200 g/kg For a full list of excipients see section 6.1
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: EXP Once opened, use within 3 months Once incorporated into meal or pelleted feed, use within 1 month
Danish: Efter opblanding i fodermel eller foderpiller anvendes inden 1 måned.
English: Luxembourg Eli Lilly Benelux N.V. Elanco Animal Health Rue del'Etuve 52-Bte 1Stoofstraat 52
Danish: Elanco Animal Health Rue del'Etuve 52-Bte Stoofstraat 52
English: 100 g tilmicosin per 1000 g Member State Marketing Authorisation Holder
Danish: 100 g tilmicosin pr. 1000 g
English: 4.2 Indications for use, specifying the target species Pigs: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin Rabbits: Prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Svin: Forebyggelse og behandling af luftvejsinfektion forårsaget af Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida og andre organismer, som er følsomme over for tilmicosin.
English: Tilmicosin (as phosphate)
Danish: Tilmicosin (som fosfat) 200 g/kg
English: The safety of tilmicosin has not been established in boars used for breeding purposes.
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning Lægemidlets sikkerhed hos orner, der bruges som avlsdyr, er ikke fastlagt.
English: Route of administration
Danish: Dyreart Indgivelsesvej
English: Absorption: When administered orally to rabbits at a dose of 12 mg tilmicosin/kg b.w.
Danish: Absorption: Ved peroral indgift af en dosis på 12 mg tilmicosin kg/kropsvægt til kaniner som en enkelt dosis absorberes veterinærlægemidlet hurtigt.
English: 6.5 Nature and composition of immediate packaging Products containing 40 and 100g tilmicosin/kg are packed in either:
Danish: Produkter indeholdende 40 og 100 g tilmicosin/kg er pakket i enten:
English: Pulmotil G 100 AMV Premix for medicated feeding stuff
Danish: Pulmotil G 100 AMV Premix til medicineret foder 100 g tilmicosin pr. 1000 g
English: Pulmotil G 20% AMV Premix for medicated feeding stuff
Danish: Pulmotil G 20% AMV Premix til medicineret foder 200 g tilmicosin pr. 1000 g
English: Pulmotil G 200 premix Premix for medicated feeding stuff
Danish: Pulmotil G 200 premix Premix til medicineret foder 200 g tilmicosin pr. 1000 g
English: Pulmotil 40 VET Premix Premix for medicated feeding stuff
Danish: Pulmotil 40 VET Premix Premix til medicineret foder 40 g tilmicosin pr. 1000 g
English: Dose of tilmicosin
Danish: Dosis af tilmicosin Behandlingsvarighed Inklusionsmængde i foder
English: Pulmotil G 40 AMV Premix for medicated feeding stuff
Danish: Pulmotil G 40 AMV Premix til medicineret foder 40 g tilmicosin pr. 1000 g
English: Pulmotil G 20% Premix for medicated feeding stuff
Danish: Pulmotil G 20% Premix til medicineret foder 200 g tilmicosin pr. 1000 g
English: Active substance: Tilmicosin (as phosphate)
Danish: Tilmicosin (som fosfat) 40 g/kg Aktivt stof:
English: Pulmotil Prämix 20% Premix for medicated feeding stuff
Danish: Pulmotil Prämix 20% Premix til medicineret foder 200 g tilmicosin pr. 1000 g
English: The European Commission granted a marketing authorisation valid throughout the European Union for Byetta on 20 November 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Byetta den 20. november 2006.
English: Byetta should never be given after a meal.
Danish: Byetta bør aldrig gives efter et måltid.
English: Byetta exenatide
Danish: Byetta exenatid
English: This document is a summary of the European public assessment report (EPAR) for Byetta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Byetta.
English: The full EPAR for Byetta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Byetta findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The pen has a user manual.
Danish: Med pennen følger en brugervejledning.
English: Byetta is used to treat type 2 diabetes.
Danish: Byetta anvendes til behandling af type 2 diabetes.
English: The first dose of the day is administered within the one hour before the morning meal, and the second dose within the one hour before the evening meal.
Danish: Dagens første dosis gives højst en time inden morgenmaden, den anden højst en time inden aftensmaden.
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 Byetta.
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 anvendelsesbetingelserne for Byetta.
English: At the start of the studies, the patients' HbA1c levels were around 8.4%.
Danish: Ved undersøgelsernes start lå patienternes HbA1c-niveauer på omkring 8,4 %.
English: Byetta was as effective as injected insulin.
Danish: Byetta var lige så effektivt som indsprøjtninger af insulin.
English: Patients were also taking either metformin or pioglitazone, or a combination of both.
Danish: Patienterne fik også enten metformin eller pioglitazon eller en kombination af begge.
English: Patients being treated with Byetta should continue to follow their diet and exercise plans.
Danish: Patienter, der er i behandling med Byetta, skal fortsætte med deres diæt og motionsplan.
English: For more information about treatment with Byetta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Byetta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Byetta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Byetta opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Byetta must not be used in people who are hypersensitive (allergic) to exenatide or any of the other ingredients.
Danish: Byetta må ikke anvendes hos personer, der er overfølsomme (allergiske) over for exenatid eller andre af indholdsstofferne.
English: The active substance in Byetta, exenatide, is an ‘incretin mimetic'.
Danish: Det aktive stof i Byetta, exenatid, er et ‘inkretinmimetikum'.
English: The dose can then be increased to 10 micrograms twice a day.
Danish: Derefter kan dosis øges til 10 mikrogram to gange dagligt.
English: Other information about Byetta:
Danish: Andre oplysninger om Byetta
English: This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food.
Danish: Det vil sige, at det virker på samme måde som inkretiner (hormoner, der produceres af tarmen) ved at få bugspytkirtlen til at afgive mere insulin som reaktion på fødeindtagelse.
English: It is used together with other antidiabetes medicines in patients whose blood glucose (sugar) levels are not adequately controlled with the maximum tolerated doses of the other medicines.
Danish: Det anvendes sammen med andre lægemidler mod diabetes hos patienter, hvis blodglukoseniveauer (blodsukker) ikke er under tilstrækkelig kontrol med de maksimale tolererede doser af andre lægemidler.
English: Treatment with Byetta should start at a dose of 5 micrograms twice a day for at least a month.
Danish: Man bør begynde behandlingen med Byetta med en dosis på 5 mikrogram to gange dagligt i mindst en måned.
English: It is available as prefilled injection pens that provide either 5 or 10 micrograms of exenatide in each dose.
Danish: Det fås som fyldte injektionspenne med enten 5 eller 10 mikrogram exenatid i hver dosis.
English: Little or no effect was seen with placebo.
Danish: Placebo havde ingen eller ringe effekt.
English: Byetta has been studied in eight main studies involving a total of around 3,000 patients whose blood glucose was not adequately controlled with other antidiabetes medicines.
Danish: Byetta blev undersøgt i otte hovedundersøgelser, som omfattede i alt ca. 3 000 patienter, hvis blodglukose ikke blev tilstrækkeligt reguleret med andre lægemidler mod diabetes.
English: Byetta is a solution for injection that contains the active substance exenatide.
Danish: Byetta er en injektionsvæske, der indeholder det aktive stof exenatid.
English: Byetta was more effective than placebo in reducing the levels of HbA1c when used in combination with other antidiabetes medicines.
Danish: Byetta var mere effektivt end placebo til at nedsætte mængden af HbA1c, når det blev brugt i kombination med andre lægemidler mod sukkersyge.