FrancophonIA/ELRC3.0 huggingface dataset:
English: 12 kg to 25 kg
Danish: 12-25 kg
English: • Put down the pre-filled syringe after unscrewing the cap.
Danish: • Læg den fyldte sprøjte fra dig efter at have skruet hætten af.
English: Statistic Firazyr
Danish: Statistik
English: • Remove the pre-filled syringe from the tray.
Danish: • Fjern den fyldte sprøjte fra bakken.
English: Other Endpoints Time to Onset of Primary Symptom Relief (hrs)
Danish: Andre effektmål Tid til de primære symptomer begyndte at lindres (timer)
English: 12.0 All episodes (N = 56)
Danish: 12,0 Alle episoder (N = 56)
English: 51.0 All episodes (N = 56)
Danish: 51,0 Alle episoder (N = 56)
English: Median time to onset of symptom relief (hours)
Danish: Mediantid til begyndelse af symptomlindring (timer)
English: Hypodermic needle is included in the pack.
Danish: Med pakken følger en hypodermisk kanyle.
English: 41 kg to 50 kg
Danish: 41-50 kg
English: Tranexamic acid
Danish: Icatibant Tranexamsyre
English: Change in Composite Subject-Assessed Symptom Score at 2 hours
Danish: Ændring i patientvurderet sammensat symptomscore 2 timer efter behandling
English: In healthy young subjects, icatibant administered in doses of 0.8 mg/kg over 4 hours; 1.5 mg/kg/day or 0.15 mg/kg/day for 3 days, development of bradykinin-induced hypotension, vasodilatation and reflex tachycardia was prevented.
Danish: 1,5 mg/kg/dag i 3 dage udviklingen af bradykinininduceret hypotension, kardilatation og reflekstakykardi.
English: What you need to know before you use Firazyr 3.
Danish: Kontakt lægen, før du bruger Firazyr.
English: 7.9 All episodes (N = 56)
Danish: 7,9 Alle episoder (N = 56)
English: Firazyr 30 mg solution for injection in pre-filled syringe
Danish: Firazyr 30 mg injektionsvæske, opløsning i fyldt injektionssprøjte.
English: 6.9 All episodes (N = 56)
Danish: 6,9 Alle episoder (N = 56)
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen til råds, før du bruger dette lægemiddel.
English: Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Firazyr.
Danish: Hvis du bemærker, at dine anfaldssymptomer bliver værre, efter at du har fået Firazyr, skal du straks kontakte en læge.
English: Solution for injection
Danish: Injektion af opløsningen
English: • Screw the syringe on the needle still fixed in the needle cap.
Danish: • Skru den fyldte sprøjte fast på kanylen, mens kanylen stadig er i kanylehætten.
English: Itching
Danish: Amning
English: Time to Almost Complete Symptom Relief (hrs)
Danish: Tid før symptomerne næsten var lindret (timer)
English: Median time to onset of symptom relief: all symptoms (hours): Abdominal pain Skin swelling Skin pain
Danish: Mediantid til begyndelse af symptomlindring alle symptomer (t):
English: --1 Attenuated infectious bursal disease virus, strain 1052, live, 101.48 to 102.63 PU* per dose * PU: Potency Units
Danish: --1 Dæmpet infektiøs bursalsygdomsvirus, stamme 1052, live, 101.48 til 102.63 PU* pr. dose * PU: Potensenheder
English: Immediate packaging
Danish: Indgivelsesvej Indre emballage
English: EU/1/16/1100/001 Palonosetron Hospira
Danish: EU/1/16/1100/001
English: 250 µg Solution for injection
Danish: Injektionsvæske, opløsning
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre, at alle de betingelser eller restriktioner med hensyn til sikkerhed og effektiv brug af lægemidlet, som er beskrevet nedenunder, er implementeret:
English: • Emphasis that: o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing < 60 kg o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of age.
Danish: • bør fremhæve at: o Alvorlige hæmoragiske hændelser er mere hyppige hos patienter ≥ 75 år (inklusive fatale hændelser) eller med vægt < 60 kg. o Patienter ≥ 75 år bør normalt ikke behandles med prasugrel.
English: o Patients weighing < 60 kg should have a reduced maintenance dose of 5mg o The evidence for a 5mg dose is based only on PK/PD analyses and no clinical data currently exist on the safety of this dose in the at risk sub groups.
Danish: o Patienter med en vægt < 60 kg bør have en reduceret vedligeholdelsesdosis på 5 mg. o Evidensen for en dosis på 5 mg er kun baseret på farmakodynamiske/farmakokinetiske analyser, og der er ingen tilgængelige kliniske data vedrørende sikkerheden for denne dosis for risikogrupperne.
English: The MAH provides educational material to all physicians who may be involved in treating patients with prasugrel.
Danish: Indehaveren af markedsføringstilladelsen bør give undervisningsmateriale til alle de læger, som kan blive inddraget i behandling af patienter med prasugrel.
English: The format and means of dissemination, of this material should be discussed by the MAH with the appropriate learned societies.
Danish: Indehaveren af markedsføringstilladelsen bør diskutere formatet og udbredelsesmåden af dette materiale i passende videnskabelige fora.
English: o If, after a careful individual benefit/risk evaluation by the prescribing physician, treatment is deemed necessary in the ≥ 75 years age group then following a loading dose of 60 mg, a reduced maintenance dose of 5mg should be prescribed.
Danish: 4.4), bør det ordineres som en 60 mg stabiliseringsdosis efterfulgt af en lavere vedligeholdelsesdosis på 5 mg.behandling.
English: It has been authorised in 16 EU Member States.
Danish: Det er godkendt i 16 EU-medlemsstater.
English: Eggs were sampled twice daily.
Danish: Der blev indsamlet æg to gange dagligt.
English: Manufacturer's batch number <Batch> <Lot> {number}
Danish: Fremstillerens batchnummer <Batch> <Lot> {nummer}
English: Three distinct multi-resistant strains were isolated.
Danish: 3 forskellige multiresistente stammer blev isoleret.
English: ATC vet code: QJ 01 XQ 01
Danish: ATCvet-kode: QJ 01 XQ 01
English: The resistance situation for these pathogens is considered favourable.
Danish: Resistensforholdene for disse patogener vurderes at være favorable.
English: The recommended harmonised indications and dosing regimens have not been extended and consequently the use of the product as recommended in the product information should not lead to increased exposure of the environment.
Danish: De anbefalede harmoniserede indikationer og doseringsregimer er ikke blevet udvidet, og derfor bør anvendelse af produktet som anbefalet i produktinformationen ikke føre til øget miljøeksponering.
English: These were achieved at about 2-4 hours after dosing.
Danish: Disse værdier blev opnået ca. 2-4 timer efter dosering.
English: No resistant strains were found.
Danish: Der blev ikke fundet resistente stammer.
English: Statement of the active substance (s) and other ingredients Each g contains:
Danish: Angivelse af de(t) aktive stof(fer) og andre indholdsstoffer 1 g indeholder:
English: To ensure the correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre den korrekte dosis skal kropsvægten bestemmes så nøjagtigt som muligt for at undgå underdosering.
English: Bactericidal concentrations can be reached but vary according to the bacterium.
Danish: Baktericide koncentrationer kan opnås, men varierer alt efter bakterien.
English: In these studies doses were expressed as concentrations in drinking water.
Danish: I disse undersøgelser blev doseringen udtrykt som koncentrationen i drikkevandet.
English: Mean body weight (kg) of animals to be treated
Danish: Gennemsnitlig kropsvægt (kg) af dyr, der skal behandles
English: Fresh solutions of tiamulin-medicated drinking water should be made up each day.
Danish: Der bør tilberedes friske opløsninger af tiamulin-medicineret drikkevand hver dag.
English: The intake of medicated water depends on the clinical condition of the animals.
Danish: Indtaget af medicineret vand afhænger af dyrenes kliniske tilstand.
English: A number of isolates in Korea and Thailand may have higher iMIC figures than previously reported in the EU and USA by Wattanaphansak et al. (2009).
Danish: En række isolater i Korea og Thailand kan have højere iMIC-tal end de tal, der tidligere er blevet rapporteret i EU og USA af Wattanaphansak et al. (2009).
English: Residues in eggs were well below the MRL at all time points.
Danish: Restkoncentrationerne i æg lå langt under maksimalgrænseværdien (MRL) på alle tidspunkter.
English: Severe growth depression or death may result.
Danish: Dette kan medføre svær væksthæmning eller død.
English: The feed should be tested for the ionophores prior to use if there is any suspicion that contamination of the feed might occur.
Danish: Foderet skal undersøges for ionophor-præparater før anvendelse, hvis der foreligger en eventuel mistanke om, at foderet kan blive kontamineret.
English: EXP {month/year}
Danish: Udløbsdato EXP {måned/år}
English: Overall summary of the scientific evaluation of Denagard 45% and its associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Denagard 45% og relaterede navne (se bilag I)
English: Consequently, a withdrawal period in eggs of zero days is accepted.
Danish: Derfor kan en tilbageholdelsestid for æg på 0 dage accepteres.
English: The dosage of the product to be incorporated should be established according to the following formula:
Danish: Doseringen af produktet bør beregnes efter følgende formel:
English: Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Danish: Navn og adresse på indehaveren af markedsføringstilladelsen samt på den indehaver af virksomhedsgodkendelse, som er ansvarlig for batchfrigivelse, hvis forskellig herfra
English: It does not appear to have any adverse effect on overall performance of the birds or efficacy of the veterinary medicinal product but water intake should be monitored at frequent intervals, especially in hot weather.
Danish: Det synes ikke at have nogen skadelig indvirkning på fuglenes almene tilstand eller på veterinærlægemidlets effekt, men vandindtaget bør overvåges med hyppige mellemrum, især i varmt vejr.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Tiamulin hydrogen fumarate
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt stof: Tiamulinhydrogenfumarat
English: People with known hypersensitivity to tiamulin should administer the veterinary medicinal product with caution.
Danish: Personer med kendt overfølsomhed over for tiamulin bør administrere lægemidlet med forsigtighed.
English: • Eggs: Zero days
Danish: • Æg: 0 dage
English: Wattanaphansak et al. (2009)5, tested 10 isolates of L. intracellularis (six from USA, four from Europe).
Danish: Wattanaphansak et al. (2009)5, testede 10 isolater af L. intracellularis (6 fra USA, 4 fra Europa).
English: Users are advised to take appropriate precautions when handling the product in order to avoid exposure.
Danish: Brugerne rådes til at tage passende forholdsregler ved håndtering af produktet for at undgå eksponering.
English: The withdrawal periods have been revised following assessment of the available residue depletion data to ensure consumer safety.
Danish: Tilbageholdelsestiderne er blevet revideret efter en vurdering af de tilgængelige restkoncentrationsdata for at sikre forbrugersikkerheden.
English: Pigs were treated at the intended dose and sacrificed 24 hours, 3, 4, 5 and 6 days after last administration.
Danish: Grise blev behandlet med den fastsatte dosis og slagtet 24 timer, 3, 4, 5 og 6 dage efter sidste administration.
English: Mean daily water consumption (litre) per animal per day
Danish: Gennemsnitligt dagligt vandindtag (liter) pr. dyr pr. dag
English: The actual doses in mg/kg body weight could only be estimated.
Danish: De faktiske doser i mg/kg legemsvægt kunne kun estimeres.
English: Use of the product should be based on susceptibility testing of the bacteria isolated from the animal.
Danish: Anvendelsen af produktet bør være baseret på følsomhedsbestemmelse af bakterier isoleret fra dyret.
English: When medicating large volumes of water, prepare a concentrated solution first and then dilute to the required final concentration.
Danish: Ved medicinering af store mængder drikkevand tilberedes først en koncentreret opløsning, som efterfølgende fortyndes til den ønskede koncentration.
English: There was some variation in the clinical results and there was a reported reduction in water intake with tiamulin in the drinking water.
Danish: Der var en vis variation i de kliniske resultater, og der blev rapporteret om reduceret vandindtagelse ved tiamulin i drikkevandet.
English: Tiamulin, which has not been absorbed or metabolised, passes down the intestines to the colon.
Danish: Tiamulin, som ikke er absorberet eller omsat, passerer ned gennem tarmene til tyktarmen.
English: = ___ mg product per litre of drinking water
Danish: = ___ mg produkt pr. liter drikkevand
English: Tiamulin has been shown to act at the 70S ribosome level and the primary binding sites are on the 50S subunit.
Danish: Det er blevet påvist, at tiamulin fungerer på 70S-ribosomniveauet, og det primære bindingssted er på 50Sunderenheden.
English: Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to tiamulin.
Danish: Uhensigtsmæssig anvendelse af veterinærlægemidlet kan øge prævalensen af bakterier, der er resistente over for tiamulin.
English: Guidance for preparing product solutions:
Danish: Vejledning i tilberedning af opløsninger:
English: In case of exposure or accidental spillage onto skin the affected area should be washed with soap and water.
Danish: I tilfælde af eksponering eller utilsigtet spild på huden bør det berørte område vaskes med sæbe og vand.
English: The in vitro susceptibility data available to support the indication are limited.
Danish: Der foreligger kun begrænsede in vitro-følsomhedsdata til understøttelse af indikationen.
English: Excretion is mainly via the bile (55-65%) and kidney (15-30%) as mainly microbiologically inactive metabolites and is quite rapid, 99% of the dose within 48 hours.
Danish: Udskillelsen sker hovedsagligt via galden (5565 %) og nyrerne (15-30 %) som primært mikrobiologisk inaktive metabolitter og er ganske hurtig, 99 % af dosis inden for 48 timer.
English: Animals with reduced water intake and/or in a debilitated condition should be treated parenterally.
Danish: Dyr med reduceret vandindtag og/eller i svækket tilstand bør behandles parenteralt.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelform, styrke, dyrearter, indgivelsesmåde, indehavere af markedsføringstilladelse i medlemsstaterne
English: See section 4.8 for information regarding interaction between tiamulin and ionophores.
Danish: 4.8 for oplysninger vedrørende interaktion mellem tiamulin og ionophor-præparater.
English: Based on the residue depletion data available the following withdrawal periods are recommended:
Danish: Ud fra de tilgængelige restkoncentrationsdata anbefales følgende tilbageholdelsestider:
English: The harmonised product information of Denagard 45% contains the necessary information to ensure the safe and effective use of the product.
Danish: Den harmoniserede produktinformation for Denagard 45% indeholder de nødvendige oplysninger til at sikre risikofri og effektiv anvendelse af lægemidlet.
English: It has been noted that Denagard 45% and its associated names do not have the same product information across the Member States with respect to e.g. target species, indications, posology and withdrawal periods
Danish: Det bemærkes, at Denagard 45% og relaterede navne ikke har samme produktinformation i medlemsstaterne, hvad angår f.eks. målarter, indikationer, dosering og tilbageholdelsestid.
English: Susceptibility testing of L. intracellularis is challenging since this is an obligate intracellular organism.
Danish: Følsomhedstest af L. intracellularis er en udfordring, da der er tale om en obligat intracellulær organisme.
English: Marketing authorisation holders
Danish: Indehaver af markedsføringstilladelsen
English: Personal protective equipment consisting of safety glasses or goggles and gloves should be worn when handling the veterinary medicinal product in order to avoid contamination of the user's eyes and topical exposure of skin.
Danish: Personligt beskyttelsesudstyr i form af sikkerhedsbriller eller beskyttelsesbriller og handsker bør anvendes ved håndtering af lægemidlet for at undgå kontaminering af brugerens øjne og topisk eksponering af huden.
English: On very rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin.
Danish: I meget sjældne tilfælde kan der forekomme erytemer eller milde ødemer på huden hos grise efter brug af tiamulin.
English: Recent M. meleagridis-isolates are difficult to obtain as it was eradicated from most breeding flocks and only rarely occurs in the field.
Danish: Det er vanskeligt at skaffe M. meleagridis-isolater af nyere dato, da denne stamme er elimineret fra de fleste besætninger og kun sjældent ses i felten.
English: The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable
Danish: Teksten “Til dyr” samt betingelser eller begrænsninger for udlevering og brug, om nødvendigt Til dyr.
English: Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro.
Danish: På grund af tekniske begrænsninger er det vanskeligt at teste følsomheden af Lawsonia intracellularis in vitro.
English: The susceptibility patterns determined in these studies were of a wild-type pattern indicating that no resistance had developed in the period investigated.
Danish: De følsomhedsmønstre, der sås i disse undersøgelser, svarede til vildtype-mønstre, hvilket peger på, at der ikke er udviklet resistens i den periode, som undersøgelserne omfatter.
English: Special warnings for each target species: Animals with reduced water intake and/or in a debilitated condition should be treated parenterally.
Danish: Særlige advarsler for hver dyreart: Dyr med reduceret vandindtag og/eller i svækket tilstand bør behandles parenteralt.
English: Dose (mg product per kg body weight per day)
Danish: Dosis (mg produkt pr. kg kropsvægt dagligt)
English: The presence of the disease in the flock must be established before the product is used.
Danish: Sygdommens tilstedeværelse i besætningen skal være fastslået, før produktet anvendes.
English: Denagard 45% is generally well tolerated in the target species and appropriate information is included in the product information.
Danish: Denagard 45% tåles generelt godt af målarterne, og relevante oplysninger er anført i produktinformationen.
English: Shelf life after first opening the immediate packaging: 3 months.
Danish: Efter første åbning af den indre emballage: 3 måneder.
English: The main areas of disharmony in the existing product information relate to target species, indications, posology and withdrawal periods.
Danish: De områder, der især er uenighed om i de eksisterende produktresuméer, vedrører målarter, indikationer, dosering og tilbageholdelsestider.
English: Currently further isolates have been tested from Korea (Yeh et al., 2011)6, Brazil and from Thailand (MAH proprietary data, 2016).
Danish: Der er desuden testet yderligere isolater fra Korea (Yeh et al., 2011)6, Brasilien og Thailand (virksomhedsinterne data fra markedsføringsindehaverne fra 2016).
English: The in vitro susceptibility of M. gallisepticum and M. synoviae from chickens and turkeys was tested intwo studies with isolates from European Member States collected from 2005-2007, and 2010-2013, and in one study with global isolates collected before 1997.
Danish: In vitro-følsomheden hos M. gallisepticum og M. synoviae fra kyllinger og kalkuner blev testet i 2 undersøgelser med isolater fra EU-medlemsstater indsamlet mellem 2005 og 2007 og mellem 2010 og 2013 samt i 1 undersøgelse med globale isolater indsamlet før 1997.
English: It has been shown to concentrate in the lung, polymorphonuclear leucocytes and also in liver, where it is metabolised and excreted (70-85%) in the bile, the remainder is excreted via the kidney (15-30%).
Danish: Det er påvist, at det koncentrerer sig i lungerne, de polymorfnukleære leukocytter og også i leveren, hvor det omsættes og udskilles (70-85 %) i galden, resten udskilles via nyrerne (1530 %).
English: The MIC50 was considered high, but the isolates presented a wild-type susceptibility pattern suggesting lack of resistance.
Danish: MIC50 ansås for at være høj, men isolaterne udviste et vildtype-følsomhedsmønster, hvilket taler for, at der ikke er udviklet resistens.
English: This includes the specification of target pathogens, replacement of the prevention claim by metaphylaxis and clear dose recommendations based on mg tiamulin hydrogen fumarate/kg body weight for each target species and indication as well as prudent use recommendations for antimicrobial veterinary medicinal products authorised in the EU.
Danish: Dette omfatter en specificering af målpatogener, en udskiftning af indikationen forebyggelse med indikationen metafylakse og tydelige dosisanbefalinger angivet i mg tiamulinhydrogenfumarat/kg legemsvægt for den enkelte målart og den enkelte indikation samt anbefalinger vedrørende forsvarlig anvendelse af antibiotiske veterinærlægemidler, der er godkendt i EU.
English: Ninety three isolates of B. pilosicoli collected in Sweden (Pringle et al. 20061), 33 isolates collected in UK, Spain and Germany (MAH proprietary data 2008) as well as 324 isolates collected in Sweden between 2002 and 2010 (Pringle et al. 20122) were tested.
Danish: 93 isolater af B. pilosicoli indsamlet i Sverige (Pringle et al. 20061), 33 isolater indsamlet i Det Forenede Kongerige, Spanien og Tyskland (interne data fra markedsføringsindehaverne fra 2008) samt 324 isolater indsamlet i Sverige mellem 2002 og 2010 (Pringle et al. 20122) blev testet.
English: Tiamulin hydrogen fumarate is well absorbed in the pig (over 90%) following oral administration and widely distributed through the body.
Danish: Tiamulinhydrogenfumarat absorberes godt hos grise (over 90 %) efter peroral administration og fordeles ud i hele kroppen.
English: The epidemiological cut-off value was considered at 16 µg/ml which corresponds to the current Clinical and Laboratory Standards Institute (CLSI) standard (S ≤16 µg/ml, R ≥32 µg/ml).
Danish: Der sås en epidemiologisk cut-off-værdi på 16 µg/ml, hvilket svarer til den nuværende CLSI-standard (Clinical and Laboratory Standards Institute) (S ≤ 16 µg/ml, R ≥ 32 µg/ml).
English: It distributes widely through the body and has been shown to concentrate in the liver and kidney (sites of excretion) and in the lung (30 times serum level).
Danish: Tiamulin fordeles ud i hele kroppen, og det er påvist, at det koncentrerer sig i leveren og nyrerne (udskillelsessteder) og i lungerne (30 gange serumniveau).
English: Lesion score reduction and reduction in microbiological re-isolation varied from 55% to 100% for prevention/metaphylaxis but were as low as 33% to 67% for treatment of M. gallisepticum.
Danish: Reduktionen i læsionsscore og reduktionen i mikrobiologisk reisolering varierede mellem 55 % og 100 %, hvad angår forebyggelse/metafylakse af M. gallisepticum, men var helt nede på 33-67 %, hvad angår behandling af M. gallisepticum.
English: The LD5 is 1090 mg/kg body weight for chickens and 840 mg/kg body weight for turkeys.
Danish: LD5 er 1090 mg/kg kropsvægt for kyllinger og 840 mg/kg kropsvægt for kalkuner.
English: Germany referred the issue due to divergent national decisions having been taken by the EU Member States resulting in discrepancies in the product information for Denagard 45%.
Danish: Tyskland indbragte sagen, fordi der som følge af divergerende nationale afgørelser er uoverensstemmelse mellem produktinformationen for Denagard 45% og relaterede navne i de forskellige EU-medlemsstater.