FrancophonIA/ELRC3.0 huggingface dataset:
English: There are also isolated reports of ototoxicity with gentamicin.
Danish: Der er desuden enkeltstående beskrivelser af ototoksicitet med gentamicin.
English: Based on all available evidence, the CVMP considered that a single daily dose of 6.6 mg gentamicin/kg bw, administered intravenously, would provide an efficacious dose, taking into account the desired PK/PD characteristics for a concentration-dependent antibiotic, i.e. optimal maximum serum concentration (Cmax) to MIC ratio of 8-10, and assuming a bacterial MIC ≤2 µg/ml.
Danish: På grundlag af al foreliggende evidens fandt CVMP, at en enkelt daglig dosis på 6,6 mg gentamicin/kg kropsvægt administreret intravenøst vil være en effektiv dosis i forhold til de ønskede farmakokinetiske/farmakodynamiske egenskaber for et koncentrationsafhængigt antibiotikum, dvs. et optimalt forhold mellem den maksimale serumkoncentration (Cmax) og MIC på 8-10 under forudsætning af en bakteriel MIC ≤2 µg/ml.
English: Latvia KELA N.V. St. Lenaartseweg 48 2320 Hoogstraten Belgium
Danish: St. Lenaartseweg 48 2320 Hoogstraten Belgien
English: Single dose of 6.6 mg/kg body weight given intravenously once daily for 3-5 consecutive days.
Danish: En enkeltdosis på 6,6 mg/kg kropsvægt intravenøst én gang dagligt i 3-5 på hinanden følgende dage.
English: Gentamicin is de-activated in the presence of inflammatory debris, low oxygen environments and low pH.
Danish: gentamicin deaktiveres ved tilstedeværelse af inflammatorisk debris, lav iltkoncentration og lavt pH.
English: Therapeutic blood monitoring of gentamicin concentration is also recommended because of known individual animal variations in peak and trough gentamicin plasma concentrations.
Danish: Terapeutisk overvågning af blodkoncentrationen af gentamicin anbefales ligeledes pga. de kendte individuelle variationer i maksimum- og minimumværdierne af plasmakoncentrationen af gentamicin.
English: Product name
Danish: Lægemiddelnavn
English: Horses declared as not being intended for slaughter for human consumption.
Danish: Heste ikke bestemt til slagtning til konsum
English: 31303 Burgdorf Germany
Danish: 31303 Burgdorf Tyskland
English: Gentamicin does not distribute to the cerebrospinal fluid.
Danish: Gentamicin går ikke over i cerebrospinalvæsken.
English: Do not exceed the proposed dosing regimen.
Danish: Overskrid ikke det angivne dosisregime.
English: Gentamicin is best considered as a narrow-spectrum Gram-negative bactericidal antimicrobial (e.g. E. coli, Proteus, Pseudomonas).
Danish: gentamicin kan bedst betragtes som et smalspektret antibiotikum med baktericid virkning på gramnegative bakterier (f.eks. E. coli, Proteus, Pseudomonas).
English: The target animal safety of injectable gentamicin products for horses is considered not proven for use in foals.
Danish: Sikkerheden af injektionspræparater indeholdende gentamicin til anvendelse hos heste anses ikke for at være godtgjort for føl.
English: The product should therefore only be used based on the benefit-risk assessment by the responsible veterinary surgeon for each individual horse, taking into account alternative available treatment.
Danish: Lægemidlet bør derfor kun anvendes på grundlag af den ansvarlige dyrlæges benefit/risk-vurdering for den enkelte hest under hensyntagen til foreliggende behandlingsalternativer.
English: The Committee therefore concluded that a single dose of 6.6 mg gentamicin/kg bw given intravenously once daily for 3-5 consecutive days would provide an efficacious dose for adult horses, when used according to the SPC.
Danish: Udvalget konkluderede derfor, at en enkelt dosis på 6,6 mg gentamicin/kg kropsvægt indgivet intravenøst én gang dagligt i 3-5 på hinanden følgende dage til voksne heste vil være en effektiv dosering ved anvendelse i henhold til produktresuméet.
English: WITHDRAWAL PERIOD Not authorised for use in horses producing meat or milk for human consumption.
Danish: TILBAGEHOLDELSESTID Ikke til anvendelse hos heste, der producerer kød eller mælk til menneskeligt konsum.
English: Gentamicin sulphate exerts concentration-dependent bacterial killing characteristics.
Danish: Gentamicinsulfat har koncentrationsafhængige baktericide egenskaber.
English: This is primarily due to its fast bacteriocidal effect against Gram-negative bacteria for which there are only limited treatment choices available, its chemical stability and synergy with betalactam antibiotics.
Danish: Dette skyldes hovedsagelig dets hurtige baktericide virkning mod gramnegative bakterier, som der kun foreligger begrænsede behandlingsmuligheder mod, dets kemiske stabilitet og dets synergetiske virkning med ß-lactamantibiotika.
English: Particular caution should be taken when administering gentamicin with other potential nephrotoxic medicinal products (containing e.g. NSAIDs, furosemide, and other aminoglycosides).
Danish: Særlig forsigtighed bør udvises ved administration af gentamicin sammen med andre potentielt nefrotoksiske lægemidler (f.eks. NSAID, furosemid samt andre aminoglykosider).
English: Where blood monitoring is available, target peak plasma gentamicin concentrations should be approximately 16-20 µg/ml.
Danish: Når overvågning af blodværdier er mulig, bør maksimalkoncentrationerne af gentamicin i plasma være 16-20 µg/ml.
English: Gentamicin does not have effects on anaerobe bacteria and mycoplasmas.
Danish: gentamicin har ingen virkning på anaerobe bakterier eller Mycoplasma.
English: It is therefore not recommended to use the product in foals.
Danish: Det frarådes derfor at anvende lægemidlet hos føl.
English: This is primarily due to its fast bacteriocidal effect against Gram-negative bacteria, its chemical stability and synergy with beta-lactam antibiotics.
Danish: Dette skyldes først og fremmest dets hurtige baktericide virkning mod gramnegative bakterier, dets kemiske stabilitet og dets synergetiske virkning med ß-lactamantibiotika.
English: Calves, foals and piglets at the age of one month
Danish: Kalve, føl og pattegrise op til 1 måned gamle
English: This monitoring includes assessing relevant kidney parameters in blood (e.g. creatinine and urea) and urinalysis (e.g. gamma glutamyl transferase/creatinine ratio).
Danish: Til overvågningen hører bestemmelse af relevante nyreparametre i blodet (f.eks. kreatinin og urinstof) og urinanalyse (f.eks. forholdet gammaglutamyltransferase/kreatinin).
English: Current knowledge suggests that foals, especially neonates, are at a higher risk of gentamicin-induced nephrotoxicity compared to adults.
Danish: Den nuværende viden tyder på, at føl, navnlig nyfødte dyr, har større risiko for gentamicininduceret nefrotoksicitet end voksne dyr.
English: Spain Laboratorios e Industrias IVEN, S.A
Danish: Spanien Laboratorios e Industrias IVEN, S.A
English: Another mechanism predominates at low concentrations in which amino acid codons are misread by tRNA and proof-reading is impaired.
Danish: Ved lave koncentrationer dominerer en anden mekanisme, hvor codonerne for aminosyrerne læses forkert af tRNA, og kontrollen af kodningen er hæmmet.
English: Lithuania Dopharma Research B.V. Zalmweg 24m 4941 VX Raamsdonksveer the Netherlands
Danish: Zalmweg 24m 4941 VX Raamsdonksveer
English: Gentamicin is primarily distributed within extracellular fluids.
Danish: Gentamicin fordeles primært i ekstracellulærvæsken.
English: N-Acetyltransferases (AAC) - catalyses acetyl CoA-dependent acetylation of an amino group
Danish: N-acetyltransferaser (AAC) - katalyserer acetyl-CoA-afhængig acetylering af en aminogruppe
English: Use only based on the benefit-risk assessment by the responsible veterinarian.
Danish: Lægemidlet bør kun anvendes på grundlag af den ansvarlige dyrlæges benefit/riskvurdering.
English: Bovine (calves up to 250 kg), porcine (suckling pigs), equine not intended for human consumption, dogs and cats
Danish: Kvæg (kalve op til 250 kg), svin (pattegrise), heste ikke bestemt til konsum, hunde, katte
English: Spain Laboratorios e Industrias IVEN, S.A.
Danish: Spanien Laboratorios e Industrias IVEN, S.A.
English: • on the basis of the available data, the CVMP considered that the indication as provided in Annex III
Danish: • CVMP fandt indikationen som angivet i bilag III begrundet i de foreliggende data.
English: The CVMP considered that the lack of data and limited scientific evidence would only support a narrow indication, i.e. “For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.”
Danish: CVMP fandt pga. de manglende data og den begrænsede videnskabelig evidens kun støtte for den snævre indikation “behandling af nedre luftvejsinfektioner hos heste forårsaget af gentamicinfølsomme aerobe gramnegative bakterier”.
English: For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.
Danish: Behandling af nedre luftvejsinfektioner hos heste forårsaget af gentamicinfølsomme aerobe gramnegative bakterier.
English: Latvia Bela-pharm GmbH & Co.KG Lohner Str. 19
Danish: Letland Bela-pharm GmbH & Co.KG Lohner Str. 19
English: O-Phosphotransferases (APH) - catalyses ATP-dependent phosphorylation of a hydroxyl group
Danish: O-fosfotransferaser (APH) - katalyserer ATP-afhængig fosforylering af en hydroxylgruppe
English: Nephrotoxicity is especially a concern in foals.
Danish: Nefrotoksicitet giver anledning til særlig betænkelighed vedrørende føl.
English: Lithuania Bela-pharm GmbH & Co.KG Lohner Str. 19
Danish: Litauen Bela-pharm GmbH & Co.KG Lohner Str. 19
English: However, no target animal safety studies using a substantiated scientific study design, as recommended in the VICH guideline 431 on target animal safety have been conducted covering the authorised dosing regimens and routes of administration in adult horses and foals, in particular in regard to gentamicin-induced nephrotoxicity.
Danish: Der er ikke udført undersøgelser som anbefalet i VICH retningslinje 431 med et velunderbygget videnskabeligt design af sikkerheden hos måldyrearten med de godkendte doseringsregimer og
English: FATRO S.p.A.
Danish: Tjekkiet FATRO S.p.A.
English: Their rate of killing increases as the gentamicin concentration increases above the minimum concentration (MIC) for a given Gram-negative pathogen, with optimal maximum serum concentration (Cmax) to MIC ratio of 8
Danish: Den baktericide virkning forstærkes, når koncentrationen af gentamicin øges ud over MIC (mindste hæmmende koncentration) for en given gramnegativ patogen.
English: Horses (non food producing horse).
Danish: Heste (ikkefødevareproducerende heste).
English: O-Adenyltransferases (ANT) - catalyses ATP-dependent adenylation of hydroxyl group
Danish: O-adenyltransferaser (ANT) - katalyserer ATP-afhængig adenylering af en hydroxylgruppe
English: Gentamicin is a narrow-spectrum Gram-negative bactericidal antimicrobial, without effects on anaerobe bacteria and mycoplasmas.
Danish: gentamicin er et smalspektret antimikrobielt middel med baktericid virkning på gramnegative bakterier og uden virkning på anaerobe bakterier og Mycoplasma.
English: Therefore, the use of the products in foals is not recommended.
Danish: Derfor frarådes anvendelse af lægemidlerne hos føl.
English: Indications
Danish: INDIKATIONER
English: Differences between neonatal foal kidneys and adults include a slower clearance of gentamicin in foals.
Danish: Hos nyfødte føl adskiller nyrerne sig fra nyrerne hos voksne dyr bl.a. ved langsommere clearance af gentamicin.
English: 4.11 Withdrawal period(s) Not authorised for use in horses producing meat or milk for human consumption.
Danish: Tilbageholdelsestid Ikke til anvendelse hos heste, der producerer kød eller mælk til menneskeligt konsum.
English: Nephrotoxicity is the main risk to the target animal from gentamicin that could occur within therapeutic doses.
Danish: Nefrotoksicitet er hovedrisikoen ved gentamicin for måldyrearten og kan optræde ved terapeutiske doser.
English: Use of the product deviating from the instructions given in the SPC increases the risk of nephrotoxicity, and may increase the prevalence of bacteria resistant to gentamicin.
Danish: Hvis anvendelsen af lægemidlet ikke følger vejledningen i produktresuméet, kan det øge risikoen for nefrotoksicitet og forekomst af gentamicinresistente bakterier.
English: Enzymatic modification is the most common type of aminoglycoside resistance.
Danish: Enzymatisk modifikation er den almindeligste form for resistens mod aminoglykosider Der er identificeret over 50 forskellige enzymer.
English: Cattle, horses (non-food producing), pigs, dogs and cats
Danish: Kvæg, heste (ikke fødevareproduce rende), svin, hunde og katte
English: Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog
Danish: Kvæg, svin, heste ikke bestemt til slagtning til konsum, katte, hunde
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
Danish: anbefalede CVMP ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende gentamicin leveret som injektionsvæske, opløsning, til anvendelse hos heste med henblik på at rette produktresuméerne, etiketteringen og indlægssedlerne som angivet i bilag III.
English: Cattle, horse, swine
Danish: Kvæg, heste, svin
English: The use of gentamicin in foals and neonates is not recommended.
Danish: Det frarådes at anvende gentamicin til føl og nyfødte dyr.
English: The dosing regimen must not be exceeded.” The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses negative for use in foals.
Danish: CVMP anså benefit/risk-forholdet for at være negativt for veterinære injektionspræparater indeholdende gentamicin til heste ved anvendelse hos føl.
English: Equine not intended for human consumption, dogs, cats
Danish: Heste ikke bestemt til konsum, hunde, katte
English: The lack of data and limited scientific evidence would only support a narrow indication, i.e. “For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gram-negative bacteria susceptible to gentamicin.” This indication is consistent with the distribution pattern of gentamicin, which is primarily in the extracellular fluid.
Danish: Pga. manglende data og begrænset videnskabelig evidens er der kun dokumentation for en snæver indikation, dvs. “behandling af nedre luftvejsinfektioner hos heste forårsaget af gentamicinfølsomme aerobe gramnegative bakterier”.
English: Only one proprietary study in support of the approved dosing regimen for a product included in the scope of this referral was provided.The CVMP considered this study was of limited value to their assessment.
Danish: Der blev kun forelagt en enkelt ikkepubliceret undersøgelse til dokumentation af det godkendte doseringsregime for et lægemiddel omfattet af denne indbringelse.
English: United Kingdom
Danish: Forenede Kongerig e
English: Horses (non-food producing)
Danish: Heste (ikkefødevarepro ducerende)
English: Non foodproducing horses, cattle and pigs
Danish: Ikkefødevarepro ducerende heste, kvæg, svin
English: The CVMP also considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive when the posology for adult horses (with appropriate warnings and advice on dosing) is changed to: “Single dose of 6.6 mg/kg bw given intravenously once daily for 3-5 consecutive days.
Danish: CVMP fandt desuden benefit/risk-forholdet positivt for veterinære injektionspræparater indeholdende gentamicin til heste, når doseringen til voksne heste (med passende advarsler og anvisninger for dosering) ændres til:
English: Non foodproducing horses, cattle, dogs and cats
Danish: Ikkefødevarepro ducerende heste, kvæg, hunde, katte
English: The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive for the following indication: “For the treatment of infections of the lower respiratory tract in horses caused by Gram-negative bacteria susceptible to gentamicin.”
Danish: CVMP anså benefit/risk-forholdet for at være positivt for veterinære injektionspræparater indeholdende gentamicin til heste ved følgende indikation:
English: Dog, cat, pig, piglets, cattle, calves, horses
Danish: Hunde, katte, svin, smågrise, kvæg, kalve, heste
English: 4.1 Target species Horses (non food-producing horses).
Danish: Dyrearter, som lægemidlet er beregnet til Heste (ikkefødevareproducerende heste).
English: Cats, cattle, dogs, horses
Danish: Katte, kvæg, hunde, heste
English: Cats, dogs, cattle, pigs, horses
Danish: Katte, hunde, kvæg, svin, heste
English: Cattle, calves, pigs, piglets, horses, cats and dogs.
Danish: Kvæg, kalve, svin, smågrise, heste, katte, hunde
English: Non foodproducing horses, cattle, pigs, dogs and cats
Danish: Ikkefødevarepro ducerende heste, kvæg, svin, hunde, katte
English: Ireland Franklin Pharmaceuticals Ltd. Athboy Road
Danish: Irland Franklin Pharmaceuticals Ltd. Athboy Road
English: Pigs, cats, cattle, dogs, horses
Danish: Svin, katte, kvæg, hunde, heste
English: Belgium Franklin Pharmaceuticals Ltd. Athboy Road
Danish: Belgien Franklin Pharmaceuticals Ltd. Athboy Road
English: Pigs, cattle, dogs, horses
Danish: Svin, kvæg, hunde, heste
English: Cattle, pigs, horses, dogs, cats
Danish: Kvæg, svin, heste, hunde, katte
English: Sweden Franklin Pharmaceuticals Ltd. Athboy Road
Danish: Sverige Franklin Pharmaceuticals Ltd. Athboy Road
English: Horse, foal, cattle, calf, pig, piglet, weaner, dog and cat
Danish: Heste, føl, kvæg, svin, kalve, svin, smågrise, fravænnede grise, hunde, katte
English: Denmark Franklin Pharmaceuticals Ltd. Athboy Road
Danish: Danmark Franklin Pharmaceuticals Ltd. Athboy Road
English: Horses, cattle, pigs, dogs and cats
Danish: Heste, kvæg, svin, hunde, katte
English: Iceland Franklin Pharmaceuticals Ltd. Athboy Road
Danish: Island Franklin Pharmaceuticals Ltd. Athboy Road
English: Spain Franklin Pharmaceuticals Ltd. Athboy Road
Danish: Spanien Franklin Pharmaceuticals Ltd. Athboy Road
English: Horses, cattle, dogs and cats
Danish: Heste, kvæg, hunde, katte
English: Cattle, horses, dogs and cats
Danish: Kvæg, heste, hunde, katte
English: Horse, foal, cattle, calf, pig, dog, cat
Danish: Heste, føl, kvæg, svin, hunde, katte
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Danish: * Relativ styrke bestemt ved en styrketest med mus, som blev sammenlignet med referencevaccine, der blev vist virksom hos kvæg
English: Intramuscular Type II hydrolytic glass vial with butyl stopper and aluminium seal
Danish: Intramuskulær Type II hydrolytisk hætteglas af glas med butylprop og aluminiumshæt te
English: Intramuscular Type I hydrolytic glass vial with butyl stopper and aluminium seal.
Danish: Intramuskulær Type I hydrolytisk hætteglas af glas med butylprop og aluminiumshæt te
English: The dose may be adjusted depending on body weight.
Danish: Dosis kan tilpasses afhængigt af kropsvægten.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arixtra on 21 March 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Arixtra den 21. marts 2002.
English: This document is a summary of the European public assessment report (EPAR) for Arixtra.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Arixtra.
English: Other information about Arixtra:
Danish: Andre oplysninger om Arixtra:
English: Arixtra fondaparinux sodium
Danish: Arixtra fondaparinuxnatrium
English: For patients having surgery, the first dose should be given six hours after the end of the operation.
Danish: Til operationspatienter skal den første dosis gives seks timer efter af operations afslutning.
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 Arixtra.
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 Arixtra.
English: The full EPAR for Arixtra can be found here.
Danish: Den fuldstændige EPAR for Arixtra findes her.
English: As with other anticoagulant medicines, the most common side effect of Arixtra is bleeding.
Danish: Som for andre antikoagulerende lægemidler er den hyppigste bivirkning ved Arixtra blødning.
English: The CHMP decided that Arixtra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Arixtra er større end risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: Treatment should be started as soon as possible after diagnosis and continued for up to eight days or until the patient is discharged from hospital.
Danish: Behandlingen bør indledes hurtigst muligt efter, at diagnosen er stillet, og bør fortsætte i op til otte dage eller indtil patienten udskrives fra hospitalet.
English: However, these results were insufficient to show whether Arixtra was more effective than unfractionated heparin or not.
Danish: Disse resultater var dog ikke tilstrækkelige til at vise, hvorvidt Arixtra var mere effektivt end ufraktioneret heparin.
English: In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots).
Danish: I alle undersøgelserne var hovedmålet for virkningen den samlede hyppighed af trombotiske hændelser (problemer forårsaget af blodpropper).
English: For more information about treatment with Arixtra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Arixtra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Blood clotting can be a problem when blood flow is disturbed in any way.
Danish: Blodpropper kan være et problem, når blodcirkulationen forstyrres.
English: Treatment should be started as soon as possible following exclusion of DVT, and should be continued for between 30 and 45 days.
Danish: Behandlingen bør indledes hurtigst muligt efter, at dyb venetrombose er udelukket, og bør fortsætte i 30-45 dage.
English: The main measure of effectiveness was the proportion of patients who died or had an ‘ischaemic event' (restriction of blood supply to an organ, including the heart).
Danish: Hovedmålet for virkningen var andelen af patienter, som døde eller var ude for en ‘iskæmisk hændelse' (begrænsning af blodforsyningen til et organ, herunder hjertet).
English: Arixtra contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Danish: Arixtra indeholder det aktive stof fondaparinuxnatrium (1,5, 2,5, 5, 7,5 eller 10 mg pr. injektionssprøjte).
English: By reducing blood clots, Arixtra can also help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack.
Danish: Ved at reducere blodpropperne kan Arixtra også medvirke til at opretholde blodtilførslen til hjertet hos patienter med angina, eller som får et hjerteanfald.
English: What is the risk associated with Arixtra?
Danish: Hvilken risiko er der forbundet med Arixtra?
English: Arixtra has also been studied in two main studies of patients with unstable angina or myocardial infarction.
Danish: Arixtra blev desuden undersøgt i to hovedundersøgelser af patienter med ustabil angina eller myokardieinfarkt.