FrancophonIA/ELRC3.0 huggingface dataset:
English: While reducing the maximum amount available for accidental injection of the user, this measure would increase the chances for accidental exposure of human beings.
Danish: Ganske vist ville den maksimale dosis, der uforsætligt kunne blive injiceret i brugeren, mindskes, men samtidig ville foranstaltningen øge risikoen for uforsætlig eksponering hos mennesker.
English: • Never carry a syringe loaded with Micotil with the needle attached.
Danish: • Transporter aldrig en sprøjte fyldt med Micotil med kanylen påsat.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, INDGIVELSESVEJ(E) OG INDGIVELSESMÅDE
English: Appropriate educational measures targeted at users (mainly the agricultural community) would be undertaken by the MAHs.
Danish: Passende uddannelsestiltag over for brugere (hovedsageligt landbruget) ville skulle varetages af indehaveren af markedsføringstilladelselsen.
English: The cardiovascular system is the target of toxicity, and this toxicity may be due to calcium channel blockade.
Danish: Målorganet for den toksiske virkning er det kardiovaskulære system, og denne toksicitet kan skyldes calciumkanalblokade.
English: The CVMP concurs with the representative of the MAHs that ‘the risk of fatal outcome as a result of an accidental injection/self-injection can be related to the following factors: dose, unrestrained animals, unprotected needles attached to a loaded syringe, working in isolation, the lack of accessible product information for emergency or health care professional to determine suitable treatments'.
Danish: CVMP er enig med repræsentanten for indehaveren af markedsføringstilladelsen i, at "risikoen for dødelig udgang ved uforsætlig injektion/selvinjektion kan relateres til følgende faktorer: dosis, ikkefastholdte dyr, ubeskyttede kanyler i en fyldt sprøjte, arbejde alene og manglende adgang til produktinformation, så redderen eller lægen kan finde frem til egnet behandling".
English: Netherlands Eli Lilly Nederland B.V. Postbus 379
Danish: Nederlandene Eli Lilly Nederland B.V.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE IMMEDIATE (VIAL) LABEL - ALL AUTHORISED PACK SIZES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE INDRE (HÆTTEGLAS)EMBALLAGE - ALLE GODKENDTE PAKNINGSSTØRRELSER
English: - Clear warning that injection of the product in human beings has been associated with fatalities; - Instructions for safe use of the product (use different needles for loading a syringe and injecting into an animal, always uncouple syringe from needle during transport); - Instructions to properly restrain animals (the one treated and others in the vicinity); - Instructions never to work alone; - Recommendation to provide the physician with the vial or the package leaflet in case of accidental injection; - Note to the physician in the package leaflet and SPC detailing the known effects of Micotil in human beings, treatments to be avoided and substances that may partially counter certain effects of Micotil, including telephone numbers of national poison centres.
Danish: - En tydelig advarsel om, at injektion af produktet hos mennesker har været forbundet med dødsfald; - Instruktion i sikker brug af produktet (brug forskellige kanyler til at fylde sprøjten og injicere dyret, skil altid sprøjten fra kanylen under transport); - Instruktion i korrekt fastholdelse af dyr (det behandlede og andre i nærheden); - Instrukser om aldrig at arbejde alene; - Anbefaling om at give lægen hætteglasset eller indlægssedlen i tilfælde af uforsætlig injektion; - Information til lægen på indlægssedlen og i produktresuméet med oplysninger om de kendte virkninger af Micotil, behandlinger, der skal undgås, samt stoffer, der delvis kan modvirke visse effekter af Micotil, herunder telefonnumre på medlemsstaternes forgiftningscentre.
English: - A residual risk remains that the veterinary surgeon may not fully comply with the recommended measures intended to ensure their personal safety (e.g. the user may fail to detach the needle from the syringe containing the product).
Danish: - Der er stadig en lille risiko for, at dyrlægen ikke fuldt ud efterlever de anbefalede personlige sikkerhedsforanstaltninger (f.eks. ved ikke at fjerne kanylen fra sprøjten med produktet).
English: These results suggest that intravenous epinephrine may be contraindicated.
Danish: Resultaterne tyder på, at intravenøs adrenalin er kontraindiceret.
English: - the Committee, having considered the referral question whether the wording of the Micotil product literature should be harmonised with regard to the volume to deliver per syringe with regard to the safety of users, unanimously did not consider such a restriction to be an appropriate measure in order to ensure appropriate user safety throughout the EU;
Danish: - Efter at have overvejet det indbragte spørgsmål om, hvorvidt ordlyden af produktlitteraturen til Micotil skulle harmoniseres med hensyn til mængden pr. sprøjte af hensyn til brugersikkerheden, mente et enstemmigt udvalg ikke, at en sådan begrænsning ville være et passende tiltag for at sikre brugersikkerhed i hele EU.
English: NOTE TO THE PHYSICIAN
Danish: INFORMATION TIL LÆGEN
English: Beta adrenergic antagonists such as propanolol exacerbated the negative inotrophy of tilmicosin in dogs.
Danish: Beta-adrenerge antagonister som propranolol forstærkede den negative inotrope virkning af tilmicosin hos hunde.
English: Under paragraph 4.4 “Special warnings for each target species”
Danish: 4.4 "Særlige advarsler for de enkelte dyrearter, lægemidlet er beregnet til"
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG III ÆNDRINGER I PRODUKTRESUMÉET
English: If a group of animals is to be treated, leave the needle in the vial as a draw-off needle for subsequent doses.
Danish: Skal flere dyr behandles, bør kanylen blive siddende i hætteglasset til brug ved udtrækning af de efterfølgende doser.
English: Under paragraph 4.9 “Amounts to be administered and administration route”
Danish: 4.9 "Dosering og indgivelsesvej"
English: Two fatalities following accidental injection of Micotil were reported in the United States but no accidental human fatality has ever been reported in Europe since the introduction of Micotil.
Danish: I USA er der indberettet to dødsfald efter uforsætlig injektion af Micotil siden introduktionen af præparatet, hvorimod der aldrig er indberettet dødsfald i Europa.
English: Doses of 2-3 ml have been reported to induce adverse effects.
Danish: Der er rapporteret om bivirkninger efter doser på 2-3 ml.
English: Dobutamine partially offset the negative inotrophic effects induced by tilmicosin in dogs.
Danish: Dobutamin ophævede delvis den negative inotrope virkning af tilmicosin hos hunde.
English: Certain others (e.g. dobutamine) have partially countered cardiac effects of tilmicosin in animal experiments (pigs and dogs).
Danish: Visse andre (f.eks. dobutamin) har i dyreforsøg (svin og hunde) delvis modvirket effekten af tilmicosin på hjertet.
English: Overall risk assessment
Danish: Samlet risikovurdering
English: Connect the syringe to the needle and inject into the base of the skin fold.
Danish: Sæt sprøjten på kanylen, og injicer i bunden af hudfolden.
English: Pneumonia: 10 mg/kg bw Interdigital necrobacillosis: 5 mg/kg bw subcutaneous use
Danish: Pneumoni: 10 mg/kg kropsvægt Interdigital necrobacillose: 5 mg/kg kropsvægt subkutan anvendelse
English: Iris mednarodna trgovina d.o.o Cesta v Gorice 8, SI-1000 Ljubljana, Slovenija
Danish: Slovenien Iris mednarodna trgovina d.o.o Cesta v Gorice 8,
English: Product trade name
Danish: Lægemidlets handelsnavn
English: Appropriate educational measures for veterinary surgeons in practice would be required of the MAH to ensure awareness of veterinary surgeons to the changed evaluation of the product.
Danish: Der vil blive stillet krav til indehaveren af markedsføringstilladelsen om passende uddannelsestiltag over for praktiserende dyrlæger for at sikre, at de er opmærksomme på produktets ændrede status.
English: Recommendation of harmonised, stringent EU user safety warnings including advice to the physician on appropriate treatment, and appropriate educational measures for users, without further restrictions
Danish: Anbefaling af strenge, harmoniserede EU-brugersikkerhedsadvarsler, herunder råd til lægen om den rette behandling, og passende uddannelsestiltag over for brugere, uden yderligere begrænsninger.
English: Additional operator safety warnings:
Danish: Supplerende brugersikkerhedsadvarsler:
English: Administration of intravenous calcium chloride should only be considered if there is positive confirmation of exposure to tilmicosin.
Danish: Intravenøs injektion af calciumchlorid bør kun overvejes, når det vides med sikkerhed, at patienten er blevet eksponeret til tilmicosin.
English: Although the actual role of CaCl2 infusion following tilmicosin exposure in humans is inconclusive because of the limited data available, it is suggested that CaCl2 infusion may help to reverse the induced changes in blood pressure and heart rate in humans.
Danish: Skønt der ud fra de begrænsede foreliggende oplysninger ikke kan drages konklusioner om den faktiske betydning af CaCl2-infusion efter tilmicosin eksponering hos mennesker, formodes CaCl2infusion at kunne modvirke de påførte ændringer i blodtryk og hjertefrekvens hos mennesker.
English: A significant number of such users is likely to not fully understand the implications of the warnings and: o may not fully apply the measures intended to ensure their personal safety (i.e. the warning not to work alone is likely to be ignored; users may fail to detach the needle from the syringe containing the product and not fully understand the risks of accidental injection); o improperly store the product, potentially leading to easier availability for misuse and abuse; o may inappropriately use any product remaining following treatment of the original animal(s) at a later time point with consequential risks.
Danish: Et væsentligt antal sådanne brugere vil sandsynligvis ikke fuldt ud forstå implikationerne af advarslerne og: o vil muligvis ikke træffe alle de nødvendige personlige sikkerhedsforanstaltninger (f.eks. ved at tilsidesætte advarslen om ikke at arbejde alene eller ved ikke at fjerne kanylen fra sprøjten med produktet eller ikke fuldt ud at forstå risikoen ved uforsætlig injektion); o vil opbevare produktet forkert, så det potentielt bliver lettere at anvende det forkert eller misbruge det; o vil måske på et senere tidspunkt bruge eventuelle produktrester efter behandling af de(t) oprindelige dyr på en forkert måde, med de risici det medfører.
English: Pre-clinical data and an isolated clinical report suggest that calcium chloride infusion may help to reverse tilmicosin induced changes in blood pressure and heart rate in humans.
Danish: Prækliniske data og et indberettet isoleret klinisk tilfælde tyder på, at infusion af calciumchlorid kan modvirke de tilmicosin-inducerede ændringer i blodtryk og hjertefrekvens hos mennesker.
English: Belgium Eli Lilly Benelux Stoofstraat 52
Danish: Eli Lilly Benelux Stoofstraat 52 1000 Brussels Belgien
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS:
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET
English: Appropriate educational measure targeted at users (veterinary surgeons and the agricultural community) would be undertaken by the MAHs.
Danish: Passende uddannelsestiltag over for brugere (dyrlæger og landbruget) ville skulle varetages af indehaveren af markedsføringstilladelsen.
English: Operator Safety Warnings:
Danish: Brugersikkerhedsadvarsler:
English: METHOD AND ROUTE OF ADMINISTRATION
Danish: INDGIVELSESMÅDE OG INDGIVELSESVEJ
English: However, serious adverse reactions after accidental injection have been reported.
Danish: Der er imidlertid indberettet svære, og i nogle tilfælde indlæggelseskrævende, bivirkninger efter uforsætlig injektion,
English: - the Committee, having considered the referral question whether the wording with regard to the safety of users of the Micotil product literature should be harmonised in respect of a restriction to use by veterinary surgeons only, by majority considered that the condition of use be harmonised to ‘For use by veterinary surgeons only'; this condition was considered essential for the safe use of the veterinary medicinal product;
Danish: - Efter at have overvejet det indbragte spørgsmål om, hvorvidt ordlyden med hensyn til brugersikkerhed i produktlitteraturen til Micotil skulle harmoniseres, således at anvendelsen blev begrænset til dyrlæger, mente et flertal i udvalget, at betingelsen skal harmoniseres til "må kun anvendes af dyrlæger".
English: CaCl2 treatment showed a positive inotropic effect on the left ventricular inotropic state after tilmicosin administration in beagle dogs.
Danish: CaCl2-behandling viste sig at have positiv inotrop virkning på venstre ventrikels inotrope tilstand efter administration af tilmicosin til beaglehunde.
English: Intravenous injection of 4.5 to 5.6 mg tilmicosin/kg followed by intravenous injection of 1 ml epinephrine (1/1000) 2 to 6 times resulted in death of all 6 injected pigs.
Danish: Intravenøs injektion af 4,5 til 5,6 mg tilmicosin/kg efterfulgt af intravenøs injektion af 1 ml epinephrin (1/1000) 2 til 6 gange medførte døden for alle seks svin, der fik injektionen.
English: For animal treatment only to be supplied only on veterinary prescription.
Danish: Må kun udleveres efter dyrlægeordination.
English: Cattle, sheep and rabbit Single dose 10 mg tilmicosin/kg bw (1 ml/30 kg bw) subcutaneous use
Danish: Kvæg, får og kaniner Enkeltdosis 10 mg tilmicosin/kg kropsvægt (1 ml/30 kg kropsvægt) subkutan anvendelse
English: Recommendation of harmonised, stringent EU user safety warnings including advice to the physician on appropriate treatment, restriction of use to veterinary surgeons only, and appropriate educational measures for users
Danish: Anbefaling af strenge, harmoniserede EU-brugersikkerhedsadvarsler, herunder råd til lægen om korrekt behandling, begrænsning af anvendelsen til dyrlæger samt passende uddannelsestiltag over for brugere
English: Recommendation of harmonised, stringent EU user safety warnings including advice to the physician on appropriate treatment, restriction of use to veterinary surgeons and other suitably qualified persons (as judged by the veterinary surgeons), and appropriate educational measures for users
Danish: Anbefaling af strenge, harmoniserede EU-brugersikkerhedsadvarsler, herunder råd til lægen om passende behandling, begrænsning af anvendelsen til dyrlæger og andre efter dyrlægens skøn kvalificerede personer samt passende uddannelsestiltag over for brugere
English: For use by veterinary surgeons only.
Danish: Må kun anvendes af dyrlæger.
English: the CVMP recommends by a majority of 18 out of 27 votes that the warnings relative to user safety of the nationally granted Marketing Authorisations be harmonised and that the conditions of use be harmonised to ‘For use by veterinary surgeons only'; the revised aspects of the Summary of Product Characteristics are set out in Annex III and the conditions considered essential for the safe use of the product, as referred to in Article 36(4) of Directive 2001/82/EC as amended, are set out in Annex IV.
Danish: anbefaler CVMP med et flertal på 18 stemmer ud af 27, at advarslerne vedrørende brugersikkerhed i de nationale markedsføringstilladelser harmoniseres, og at betingelserne for anvendelse harmoniseres til "må kun anvendes af dyrlæger".
English: Discussion of risk management options
Danish: Redegørelse for risikostyringsscenarier
English: 1ml Micotil per 30 kg bw (equivalent to 10mg tilmicosin per kg bw).
Danish: 1 ml Micotil pr. 30 kg kropsvægt (svarende til 10 mg tilmicosin pr. kg kropsvægt)
English: NOTE TO THE PHYSICIAN: Please see inside part of label or package leaflet for details.
Danish: INFORMATION TIL LÆGEN: Nærmere information findes på indersiden af etiketten eller indlægssedlen.
English: In dogs, treatment with intravenous calcium chloride showed a positive effect on the left ventricular inotropic state and some improvements in vascular blood pressure and tachycardia.
Danish: Hos hunde har intravenøs injektion af calciumchlorid udvist positiv virkning på den inotrope tilstand af venstre ventrikel og resulteret i nogen bedring i vaskulært blodtryk og takykardi.
English: Single dose 10 mg Tilmicosinum/ kg bw equivalent to 1 ml per 30 kg bw, during 3-4 days subcutaneous use.
Danish: Enkeltdosis 10 mg Tilmicosinum/kg kropsvægt svarende til 1 ml pr. 30 kg kropsvægt i 3-4 dage subkutan anvendelse
English: Pigs given 4.5 to 5.6 mg tilmicosin/kg intravenously with no epinephrine all survived.
Danish: Svin, der fik 4,5 til 5,6 mg tilmicosin/kg intravenøst uden adrenalin, overlevede alle.
English: Single dose 10 mg tilmicosin per kg bw, corresponding to 1 ml Micotil 300 per 30 kg bw subcutaneous use
Danish: Enkeltdosis 10 mg tilmicosin pr. kg kropsvægt, svarende til 1 ml Micotil 300 pr. 30 kg kropsvægt subkutan anvendelse
English: In dog studies, tilmicosin induced a negative inotropic effect with consequent tachycardia, and a reduction in systemic arterial blood pressure and arterial pulse pressure.
Danish: I forsøg med hunde har tilmicosin medført en negativ inotrop virkning med deraf følgende takykardi og fald i det systemiske arterielle blodtryk og arterielle pulstryk.
English: In dogs, CaCl2 treatment showed a positive effect on the left ventricular inotrophic state after tilmicosin administration and some changes in vascular blood pressure and heart rate.
Danish: Hos hunde udviste CaCl2-behandling positiv virkning på den inotrope tilstand af venstre ventrikel efter administration af tilmicosin, samt nogen virkning på det vaskulære blodtryk og hjertefrekvensen.
English: In pigs, intramuscular injection of 10 mg tilmicosin/kg caused increased respiration, emesis and convulsions; 20 mg/kg resulted in mortality in 3 of 4 pigs, and 30 mg/kg caused the death of all 4 pigs tested.
Danish: 20 mg/kg var dødelig hos tre af fire svin, og 30 mg/kg medførte døden hos alle fire svin i forsøget.
English: Single dose 1 ml/30 kg bw subcutaneous use
Danish: Enkeltdosis 1 ml/30 kg kropsvægt subkutan anvendelse
English: Single dose 1 ml Micotil 300 per 30 kg bw (10 mg tilmicosin/kg bw) subcutaneous use
Danish: Enkeltdosis 1 ml Micotil 300 pr. 30 kg kropsvægt (10 mg tilmicosin/kg kropsvægt) subkutan anvendelse
English: However, the fact that the attending veterinary surgeon needs to ascertain the competence of the user, with both parties signing a form, is likely to minimise the risk of failure of this part of the measures; - While with this option the users of Micotil are more likely to understand the implications of the recommended warnings, a risk, though arguably lower than for option number 3, remains that: o the recommended measures intended to ensure their personal safety are not fully applied (i.e. the warning not to work alone is likely to be ignored; users may fail to detach the needle from the syringe containing the product and not fully understand the risks of accidental injection); o the product is not stored properly, potentially leading to easier availability for misuse and abuse; o any product remaining following treatment of the original animal(s) may be inappropriately used at a later time point with consequential risks.
Danish: Der består dog stadig en risiko, om end den er lavere end for mulighed 3, for, at: o de anbefalede personlige sikkerhedsforanstaltninger ikke overholdes fuldt ud (f.eks. ved at advarslen om ikke at arbejde alene tilsidesættes, eller ved at kanylen ikke fjernes fra sprøjten med produktet, eller risikoen ved uforsætlig injektion ikke fuldt ud forstås) o produktet opbevares forkert, så det potentielt bliver lettere at anvende det forkert eller misbruge det o eventuelle produktrester efter behandling af de(t) oprindelige dyr måske på det senere tidspunkt bruges på en forkert måde, med de risici det medfører.
English: 0.5 - 1ml Micotil per 30 kg bw (equivalent to 5-10mg tilmicosin per kg bw) subcutaneous use
Danish: Interdigital necrobacillose hos kvæg: 0,5-1 ml Micotil pr. 30 kg kropsvægt (svarende til 5-10 mg tilmicosin pr. kg kropsvægt) subkutan anvendelse
English: 1000 Brussels
Danish: SI-1000 Ljubljana, Slovenien
English: Single dose 1 ml for 30 kg bw (i.e. 10 mg of tilmicosin/kg bw) subcutaneous use
Danish: Enkeltdosis 1 ml til 30 kg kropsvægt (dvs. 10 mg tilmicosin/kg kropsvægt) subkutan anvendelse
English: - the Committee unanimously considered it necessary that the user safety warnings for the products concerned be harmonised throughout the EU in order to ensure appropriate user safety, in consideration of the referral question whether the wording with regard to the safety of users of the Micotil product literature should be harmonised;
Danish: - Efter at have overvejet det indbragte spørgsmål om, hvorvidt ordlyden vedrørende brugersikkerhed i produktlitteraturen til Micotil skulle harmoniseres, mente et enstemmigt udvalg, at det er nødvendigt at harmonisere brugersikkerhedsadvarslerne på de berørte produkter i hele EU af hensyn til brugersikkerheden..
English: Single dose 10 mg tilmicosin per kg bw (1ml per 30 kg bw) subcutaneous use
Danish: Enkeltdosis 10 mg tilmicosin pr. kg kropsvægt (1 ml pr. 30 kg kropsvægt) subkutan anvendelse
English: Single dose 10 mg of tilmicosin/kg bw subcutaneous use
Danish: Enkeltdosis 10 mg tilmicosin/kg kropsvægt subkutan anvendelse
English: • In case of human injection SEEK IMMEDIATE MEDICAL ATTENTION and take the vial or the package leaflet with you.
Danish: • Ved injektion i mennesker: SØG STRAKS LÆGEHJÆLP, og medbring hætteglasset eller indlægssedlen.
English: • In case of human injection SEEK IMMEDIATE MEDICAL ATTENTION and take this package leaflet or the vial with you.
Danish: • Ved injektion i mennesker: SØG STRAKS LÆGEHJÆLP, og medbring denne indlægsseddel eller hætteglasset.
English: In pigs, tilmicosin-induced lethality is potentiated by adrenalin.
Danish: Adrenalin potentierer den dødelige virkning af tilmicosin hos svin.
English: Single dose 10 mg/kg bw subcutaneous use
Danish: Enkeltdosis 10 mg/kg kropsvægt subkutan anvendelse
English: Single dose Sheep: 10 mg/kg bw
Danish: 10 mg/kg kropsvægt Kvæg:
English: This overview was last updated in February 2018.
Danish: Dette sammendrag blev senest ajourført i februar 2018.
English: Pregnant or breast-feeding women should not handle this medicine.
Danish: Gravide eller ammende kvinder bør ikke håndtere dette lægemiddel.
English: Clevor must not be used in dogs:
Danish: Clevor må ikke anvendes hos hunde:
English: Further information on Clevor can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Clevor findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Clevor received a marketing authorisation valid throughout the EU on 13 April 2018.
Danish: Clevor fik en markedsføringstilladelse med gyldighed i hele EU den 13/04/2018.
English: Other information about Clevor
Danish: Andre oplysninger om Clevor
English: It contains the active substance ropinirole.
Danish: Det indeholder det aktive stof ropinirol.
English: If the dog does not vomit within 15 minutes of treatment, treatment may be repeated.
Danish: Kaster hunden ikke op i løbet af 15 minutter efter behandlingen, kan behandlingen gentages.
English: The European Medicines Agency decided that Clevor's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Clevor opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: People who are hypersensitive (allergic) to ropinirole should avoid contact with Clevor.
Danish: Personer, som er overfølsomme (allergiske) over for ropinirol, bør undgå kontakt med Clevor.
English: An overview of Clevor and why it is authorised in the EU
Danish: En oversigt over Clevor og hvorfor det er godkendt i EU