FrancophonIA/ELRC3.0 huggingface dataset:
English: Dermatitis allergic, vascular disorders, such as malaise with hypotension, with or without loss of consciousness and arterial or venous thrombosis, and hypersensitivity reactions including anaphylaxis have been reported.
Danish: Allergisk dermatitis, vaskulære forstyrrelser som f.eks. utilpashed med hypotension med eller uden bevidsthedstab og arterie- eller venetrombose samt overfølsomhedsreaktioner, herunder anafylaksi, har været indberettet.
English: The Committee considered that evidence from randomised clinical trials and observational studies support the use of tranexamic acid in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Danish: • Udvalget tog i betragtning, at evidens fra randomiserede, kliniske undersøgelser og observationsundersøgelser understøtter anvendelse af tranexamsyre til patienter, der får foretaget dentale eller kirurgiske indgreb eller er i risiko for blødningskomplikationer.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations for tranexamic acid containing medicinal products presented by the EMA
Danish: Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelserne for lægemidler indeholdende tranexamsyre fremlagt af EMA
English: The CHMP identified that information on disseminated intravascular coagulation, visual disturbances including impaired colour vision, thromboembolism, haematuria and convulsions should be appropriately reflected through warnings and recommendations in the product information.
Danish: CHMP identificerede, at information om dissemineret intravaskulær koagulation, synsforstyrrelser inklusive nedsat farvesyn, tromboemboli, hæmaturi og kramper bør være korrekt reflekteret i advarsler og anbefalinger i produktoplysningerne.
English: The Committee considered all data provided by the MAHs in writing, including data available from literature reviews.
Danish: • Udvalget tog alle skriftlige data fra indehaverne af markedsføringstilladelserne i betragtning, inklusive foreliggende data fra gennemgang af litteraturen.
English: In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of TXA, and considering the adverse reactions profile (some of which serious) associated with the use of TXA, the CHMP considered that some of these indications should be removed.
Danish: På baggrund af de identificerede, alvorlige begrænsninger ved dataene om virkningen, foreliggende ny evidens og/eller aktuel medicinsk viden om anvendelse af TXA samt bivirkningsprofilen (af hvilke nogle bivirkninger er alvorlige) for anvendelse af TXA taget i betragtning, fandt CHMP, at nogle af disse indikationer burde slettes.
English: In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of TXA, and considering the adverse reactions profile (some of which serious) associated with the use of TXA, the CHMP considered that for some of the therapeutic indications the benefits no longer outweigh the risks and therefore they should be removed.
Danish: • På baggrund af de identificerede, alvorlige begrænsninger ved dataene om virkningen, foreliggende ny evidens og/eller aktuel medicinsk viden om anvendelse af TXA samt bivirkningsprofilen (af hvilke nogle bivirkninger er alvorlige) associeret med anvendelse af TXA taget i betragtning, fandt CHMP, at for visse af de terapeutiske indikationer opvejer fordelene ikke længere risiciene, og disse indikationer bør derfor slettes.
English: Figure: 3.
Danish: Følgende noteres:
English: Grounds for amendment of the marketing authorisations of tranexamic acid containing medicinal products listed in Annex I
Danish: Begrundelser for ændring af markedsføringstilladelserne til de i bilag I anførte lægemidler indeholdende tranexamsyre
English: The MAH informed that for children, some recent pharmacokinetic studies conducted with tranexamic acid in the paediatric population should provide relevant information.
Danish: • Indehaveren af markedsføringstilladelsen informerede om, at for børn bør visse nyere farmakokinetiske undersøgelser af anvendelse af tranexamsyre til børn og unge kunne give relevante oplysninger.
English: In particular the therapeutic indications were updated to reflect current scientific knowledge on the use of TXA; other changes to the product information were inclusion information on disseminated intravascular coagulation, visual disturbances including impaired colour vision, thromboembolism, haematuria and convulsions as warnings and recommendations.
Danish: Andre ændringer til produktoplysningerne var inklusion af information om dissemineret intravaskulær koagulation, synsforstyrrelser inklusive nedsat farvesyn, tromboemboli, hæmaturi og kramper i form af advarsler og anbefalinger.
English: Allergic reactions to these substances may occasionally be serious.
Danish: Allergiske reaktioner over for disse substanser kan lejlighedsvis være alvorlige.
English: No special precautions.
Danish: Ingen særlige forholdsregler.
English: The CVMP was asked to address the following specific points:
Danish: CVMP blev bedt om at behandle følgende specifikke punkter:
English: Experimental studies have been provided to support this statement.
Danish: Der er fremlagt eksperimentelle undersøgelser, som understøtter denne udtalelse.
English: Formula A:
Danish: Formul A:
English: After 24 hours, the levels were too low in comparison with the MIC90.
Danish: Efter 24 timer var niveauet for lavt sammenlignet med MIC90.
English: Animals were slaughtered at 12, 24, 36, 48 and 72 hours after the last treatment.
Danish: Dyrene blev slagtet 12, 24, 36, 48 og 72 timer efter den sidste behandling.
English: The benefit of prednisolone is considered as indirect and is expected to be of short term.
Danish: Fordelen ved prednisolon betragtes som indirekte og forventes at være kortvarig.
English: Do not use after the expiry date stated on the label after “EXP”.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten efter ”EXP”.
English: The tolerance of the product formulation was acceptable.
Danish: Tolerancen over for produktformuleringen var acceptabel.
English: Rzymowskiego 34 02 - 697 Warszawa Poland
Danish: Rzymowskiego 34 02 - 697 Warszawa Polen
English: The milk withdrawal period was supported by two residue depletion studies.
Danish: Tilbageholdelsesperioden for mælk blev understøttet af to restkoncentrationsundersøgelser.
English: 811 09 Bratislava Slovak Republic
Danish: 811 09 Bratislava Slovakiet
English: Milk:
Danish: Mælk:
English: No statistical difference was shown clinically and bacteriologically between both products.
Danish: Der blev ikke påvist nogen statistisk klinisk og bakteriologisk forskel mellem de to lægemidler.
English: Do not use in cases associated with Pseudomonas.
Danish: Må ikke anvendes i tilfælde associeret med Pseudomonas.
English: 1210 Wien Austria
Danish: 1210 Wien Østrig
English: The posology was supported by the two clinical trials performed in the United Kingdom and France (please see above).
Danish: Doseringen er understøttet af to kliniske undersøgelser gennemført i Det Forende Kongerige og Frankrig (se ovenfor).
English: The longer than necessary withdrawal period provides a margin of safety that covers any concerns relating to cases of prolonged duration of treatment.
Danish: Tilbageholdelsesperioden, som er længere end nødvendig, giver en sikkerhedsmargin, som dækker eventuelle betænkeligheder i forbindelse med tilfælde af forlænget behandlingsvarighed.
English: However the presence of prednisolone in the product does not represent a risk for the animal or public health.
Danish: Tilstedeværelse af prednisolon i lægemidlet udgør imidlertid ingen risiko for dyret eller for den offentlige sundhed.
English: Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Danish: Håndter ikke dette lægemiddel, hvis du ved, at du er overfølsom, eller hvis du er blevet frarådet at arbejde med sådanne præparater.
English: Hungary Pfizer Kft. Alkotás u. 53.
Danish: Ungarn Pfizer Kft. Alkotás u. 53.
English: PFIZER ITALIA Via Valbiondone 113 00188 Roma Italy
Danish: PFIZER ITALIA Via Valbiondone 113 00188 Roma Italien
English: Ramstage Road
Danish: Ramsgate Road
English: Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.
Danish: Hævelse af ansigt, læber eller øjne eller vejrtrækningsbesvær er meget alvorlige symptomer, der kræver omgående lægehjælp.
English: While these experimental studies showed a positive effect of prednisolone on udder inflammation at some time-points following treatment, there were statistical deficiencies (small numbers of cows included, no grouped statistical analyses of sets of data) that meant that conclusions could not be drawn on the significance of the observed effects.
Danish: Mens disse eksperimentelle undersøgelser viste en positiv effekt af prednisolon på yverinflammation på nogle tidspunkter efter behandling, var der statistiske mangler (et lille antal køer inkluderet, ingen grupperede, statistiske analyser af datasæt), hvilket betød, at der ikke kunne drages konklusioner om signifikansen af de observerede virkninger.
English: Since no bio-accumulation in milk has been observed, a longer duration of treatment would have no impact on the withdrawal period.
Danish: Da der ikke er observeret nogen bioakkumulering i mælk, ville en længere behandlingsvarighed ikke påvirke tilbageholdelsesperioden.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Synulox Lactating Cows and associated names and differences between the summary of product characteristics (SPC) of the product as authorised in the Member States, the issue was referred on 26 March 2010 by Belgium and Denmark to the CVMP under Article 34(1) of Directive 2001/82/EC.
Danish: På grund af de divergerende nationale beslutninger truffet af medlemsstaterne vedrørende godkendelse af Synulox Lactating Cow og relaterede navne og divergenser mellem de nationalt godkendte produktresuméer i medlemsstaterne blev sagen den 26. marts 2010 indbragt for CVMP af Belgien og Denmark i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF.
English: Values were below the maximum residue limits from the 5th milking and the half-life was estimated to be less than 12 hours.
Danish: Værdierne lå under de maksimale restgrænser fra den femte malkning, og halveringstiden blev bedømt til at ligge under 12 timer.
English: Regarding the risk to prednisolone, tolerance of the product formulation is acceptable.
Danish: Med hensyn til risikoen ved prednisolon er tolerancen over for produktformuleringen acceptabel.
English: While a withdrawal period of 3 days could have been derived from the dataset, a withdrawal time of 7 days was recommended by the marketing authorisation holders.
Danish: Mens en tilbageholdelsesperiode på 3 dage kunne have været udledt af datasættet, anbefalede indehaverne af markedsføringstilladelsen en tilbageholdelsesperiode på 7 dage.
English: Veterinární divizeAnumal Health Stroupežnického 17 150 00 Praha 5
Danish: Veterinární divizeAnumal Health Stroupežnického 17 150 00 Praha 5 Tjekkiet
English: Benefit-risk assessment
Danish: Risk/benefit-vurdering
English: After the third infusion, the MIC90 of Escherichia coli was covered well for 10 hours and the levels were partially acceptable at 12 hours.
Danish: Efter den tredje infusion var MIC90 for Escherichia coli godt dækket i 10 timer, og niveauet var delvis acceptabelt ved 12 timer.
English: The Minimum Inhibitory Concentration (MIC) of a number of different mastitis pathogens from a range of EU Member States and therefore from a range of husbandry conditions were reviewed.
Danish: Den mindste hæmmende koncentration (MIC) af et antal forskellige mastitispatogener fra en række EU-medlemsstater og således fra en række avlsvilkår blev gennemgået.
English: This combination is effective against -lactamase producing organisms.
Danish: Denne kombination er effektiv mod -lactamaseproducerende organismer.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, withdrawal period, marketing authorisation holders in the member states
Danish: Liste over navne, lægemiddelform, styrker af de veterinære lægemidler, dyreart, tilbageholdelsestid, indehaverne af markedsføringstilladelsen i medlemslandene
English: Efficacy against the target pathogens
Danish: Virkning mod målpatogener
English: Discussion of the data available
Danish: Drøftelse af de foreliggende data
English: If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.
Danish: Hvis du udvikler symptomer efter kontakt med dette lægemiddel, så som hududslæt, skal du søge lægehjælp og vise lægen denne advarsel.
English: No adverse reactions are to be expected from an accidental overdose.
Danish: Der kan ikke forventes bivirkninger ved en utilsigtet overdosis.
English: Therefore the marketing authorisation holders' proposal to remove such a recommendation from the product information was accepted by the CVMP.
Danish: Derfor blev forslaget fra indehaveren af markedsføringstilladelsen om at slette en sådan anbefaling fra produktresuméet accepteret af CVMP.
English: Notwithstanding the conclusions on the efficacy of prednisolone, the combination was deemed efficacious against the claimed pathogens.
Danish: På trods af konklusionerne vedrørende virkningen af prednisolon blev kombinationen bedømt som effektiv mod de anførte patogener.
English: By using the most conservative method of calculating the time to safe concentration and including the 5th milking in the calculations, a withdrawal period of 6.1 milkings or 73.4 hours was calculated which is rounded to 7 milkings or 84 hours.
Danish: Ved at anvende de mest konservative beregningsmetoder for tiden til sikker koncentration og inkludere den femte malkning i beregningerne blev der beregnet en tilbageholdelsesperiode på 6,1 malkninger eller 73,4 timer, hvilket afrundes til 7 malkninger eller 84 timer.
English: Regarding the efficacy against Escherichia coli, it is recognised that the product may not be indicated in case of self-cure.
Danish: Med hensyn til virkningen mod Escherichia coli anerkendes det, at lægemidlet måske ikke er indiceret i tilfælde af selvhelbredelse.
English: One syringe (3 g) contains:
Danish: 1 sprøjte (3 g) indeholder:
English: SYNULOX L.C. (200mg + 50mg + 10mg)/3g, zawiesina dowymieniowa, bydło
Danish: SYNOLUX L.C. (200mg + 50mg + 10mg)/3g, zawiesina dowymieniowa, bydło
English: Overall summary of the scientific evaluation of Synulox Lactating Cow and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Synulox Lactating Cow og relaterede navne (se bilag I)
English: No immune modulating effects of prednisolone were observed.
Danish: Der blev ikke observeret immunmodulerende virkninger af prednisolon.
English: The overall review indicates that over the six years covered by the data from the Netherlands, there was no evidence of significant and consistent increases in MIC levels of amoxycillin/clavulanic acid and cephalosporins.
Danish: Den samlede gennemgang tyder på, at der i løbet af de seks år, som dataene fra Holland dækker, ikke er tegn på signifikante eller konsekvente stigninger i MIC-niveauer for amoxycillin/clavulansyre og cefalosporiner.
English: Prednisolone administered before Escherichia coli endotoxin challenge may reduce the quarter size at some time points within 8 hours.
Danish: Prednisolon administreret før Escherichia coli endotoxin-eksponering kan reducere områdets størrelse på nogle tidspunkter inden for 8 timer.
English: The comparator product had a different composition (cloxacillin-ampicillin combination).
Danish: Sammenligningslægemidlet havde en anden sammensætning (kombination af cloxacillin og ampicillin).
English: Appropriate recommendations for prudent use of the product were recommended.
Danish: Der er givet relevante anbefalinger for forsigtig anvendelse af lægemidlet.
English: Low density polyethylene syringes packed in cartons containing 3, 12, 24 or 300 syringes.
Danish: Sprøjter af lavdensitetspolyethylen pakket i æsker indeholdende 3, 12, 24 eller 300 sprøjter.
English: Rivium Westlaan 142 2909 LD Capelle a/d Ijssel
Danish: Holland Pfizer Rivium Westlaan 142 2909 LD Capelle a/d Ijssel
English: In the first study performed in 8 lactating dairy cows, amoxicillin was the limiting active substance to determine the withdrawal period which, according to these data, should be set at 7 milkings (84 hours).
Danish: I den første undersøgelse med 8 diegivende malkekøer var amoxicillin det begrænsende aktive stof, der bestemte tilbageholdelsesperioden, som i henhold til disse data skulle være 7 malkninger (84 timer).
English: As a conclusion, the marketing authorisation holders could not demonstrate the efficacy of prednisolone when included in the combination.
Danish: Som konklusion kunne indehaverne af markedsføringstilladelsen ikke påvise prednisolons virkning, når den var inkluderet i kombinationen.
English: Harmonisation of the withdrawal periods
Danish: Harmonisering af tilbageholdelsesperioderne
English: 3 syringes 12 syringes 24 syringes 300 syringes 350 syringes
Danish: 3 sprøjter 12 sprøjter 24 sprøjter 300 sprøjter
English: The identified isolates of ESBL carrying strains, particularly from mastitis pathogens does not appear to be increasing at a rate to cause major concern.
Danish: De identificerede isolater af ESBL-bærende stammer, primært fra mastitispatogener, ser ikke ud til at stige med en hastighed, som giver anledning til alvorlig bekymring.
English: After intramammary infusion, prednisolone can lead to a reduction in the local signs of inflammation (swelling and subsequent size of the infected quarter)” to be replaced with “Prednisolone is an anti-inflammatory corticosteroid.”.
Danish: Efter intramammær infusion kan prednisolon medføre reduktion af lokale tegn på inflammation (hævelse og efterfølgende størrelse af det inficerede område)” erstattes med “Prednisolon er et antiinflammatorisk kortikosteroid.”
English: Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa.
Danish: Overfølsomhed over for penicilliner kan medføre krydsreaktioner over for cephalosporiner og omvendt.
English: Based on the two clinical trials described above it was not possible to draw a conclusion on the added value of prednisolone, because there was no comparison with a product including amoxicilline/cavulanic acid without prednisolone.
Danish: På basis af de to kliniske forsøg, som er beskrevet ovenfor, var det ikke muligt at drage en konklusion om merværdien af prednisolon, da der ikke var nogen sammenligning med et lægemiddel, som inkluderede amoxicillin/clavulansyre uden prednisolon.
English: Intramammary emulsion
Danish: Intramammær emulsion
English: Meat: 42 days.
Danish: Kød: 42 dage.
English: A pharmacokinetic study demonstrated that prednisolone does not have a prolonged residence time in the milk/udder (about 8-10 hours post infusion, levels of prednisolone were less than 1µg/ml).
Danish: En farmakokinetisk undersøgelse har påvist, at prednisolon ikke har en forlænget opholdstid i mælken/yveret (cirka 8-10 timer efter infusion var niveauet af prednisolon mindre end 1 µg/ml).
English: In a Streptococcus uberis challenge, a single administration of the product reduced the udder swelling 4 and 6 hours post treatment, but no significant action was seen on the cellular response.
Danish: Ved et tilfælde af Streptococcus uberis reducerede en enkelt administration af lægemidlet yverets hævelse med 4 og 6 timer efter behandlingen, men der blev ikke set nogen signifikant virkning på cellereaktionen.
English: Recommendations for prudent use
Danish: Anbefalinger for forsvarlig anvendelse
English: However, the self-cure effect for the Escherichia coli infections was not considered.
Danish: Den selvhelbredende virkning med hensyn til Escherichia coli-infektionerne blev imidlertid ikke taget i betragtning.
English: Therefore the CVMP has recommended the variation of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Synulox Lactating Cow and associated names (see Annex I).
Danish: Derfor anbefalede CVMP ændringen af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Synulox Lactating Cow og relaterede navne (se bilag I).
English: According to the provided pharmacodynamic data, the claimed pathogens are sensitive to the clavulanic acid / amoxicillin combination.
Danish: I henhold til de fremlagte farmakodynamiske data er de angivne patogener følsomme over for kombinationen af clavulansyre/amoxicillin.
English: MANUFACTURER'S BATCH NUMBER Batch
Danish: FREMSTILLERENS BATCHNUMMER
English: The withdrawal periods of 84 hours for milk and 7 days for meat and offal were adequately justified.
Danish: Tilbageholdelsesperioden på 84 timer for mælk og 7 dage for kød og indmad er tilstrækkeligt begrundet.
English: Amoxicillin residues were the limiting factor in liver and kidney.
Danish: Rester af amoxicillin var den begrænsende faktor i lever og nyre.
English: The reason for divergent national decisions regarding the authorisation of the products was mainly the justification of the combination of amoxicilline/clavulanic acid/prednisolone for the treatment of bovine mastitis.
Danish: Årsagen til de divergerende nationale beslutninger vedrørende lægemidlets godkendelse var primært begrundelsen for kombinationen af amoxicillin/clavulansyre/prednisolon til behandling af bovin mastitis.
English: Based on the past and recent data, the incidence of pathogens producing β-lactamase, i.e. Staphylococcus aureus and Escherichia coli from cases of bovine mastitis can be considered as high in some regions.
Danish: På baggrund af tidligere og nyere data kan forekomsten af patogener, som producerer β-lactamase, dvs. Staphylococcus aureus og Escherichia coli, fra tilfælde af bovin mastitis betragtes som høj i visse regioner.
English: For Escherichia coli MIC90 (16 µg/ml), individual milk levels in amoxicillin were above the MIC90 for the period covering the first 2 infusions.
Danish: For Escherichia coli MIC90 (16 µg/ml) lå de individuelle mælkeniveauer i amoxicillin over MIC90 i den periode, som dækker de første 2 infusioner.
English: As a conclusion, the residue depletion data support the withdrawal periods of 84 hours for milk and 7 days for meat and offal.
Danish: Som konklusion understøtter restkoncentrationsdataene tilbageholdelsesperioden på 84 timer for mælk og 7 dage for kød og indmad.
English: The use of the product should preferably be based on susceptibility tests.
Danish: Anvendelsen af produktet bør fortrinsvis baseres på følsomhedstests.
English: There is little evidence of a real increase in amoxycillin/clavulanic acid resistance among the mastitic E. coli isolated in a number of European countries.
Danish: Der er kun ringe evidens for en ægte stigning i resistens over for amoxycillin/clavulansyre hos E.coli ved mastitis, som er isoleret i et antal europæiske lande.
English: Since the product has been shown to be efficacious for the claimed indication and no risk has been identified to its use from clinical trials and pharmacovigilance, the benefit/risk balance is deemed positive.
Danish: Da lægemidlet har vist sig at være effektivt ved den indikation, der ansøges om, og da kliniske undersøgelser og lægemiddelovervågning ikke har påvist nogen risiko ved brugen, anses risk/benefitforholdet for at være positivt.
English: Handle this product with great care to avoid exposure, taking all recommended precautions.
Danish: Håndter dette lægemiddel med stor forsigtighed og under iagttagelse af alle fornødne forholdsregler for at undgå eksponering.
English: Two clinical trials have been provided for Synulox Lactating Cow and associated names:
Danish: To kliniske undersøgelser er fremlagt for Synulox Lactating Cow og relaterede navne: