FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, the CHMP is of the opinion that the benefit-risk balance of the vancomycin-containing products included in the scope of this procedure remains positive under normal conditions of use, taking into account the agreed changes to the product information as set out in Annex III to the opinion.
Danish: Alt i alt er CHMP af den opfattelse, at benefit/risk-forholdet for de af denne procedure omfattede produkter indeholdende vancomycin fortsat er positivt under normale anvendelsesbetingelser, forudsat at de vedtagne ændringer, som fremgår af bilag III til denne udtalelse, indarbejdes i produktinformationen.
English: The wording on therapeutic drug monitoring in section 4.2 of the SmPC has been amended accordingly by the CHMP.
Danish: CHMP har tilsvarende ændret ordlyden om terapeutisk lægemiddelovervågning i punkt 4.2 af produktresuméet.
English: In its assessment, the CHMP reviewed all available data, including submissions by the marketing authorisation holders during the procedure and consulted the Paediatric Committee (PDCO), the CHMP relevant working parties/groups: Infectious Disease working party (IDWP), the Pharmacokinetics working party (PKWP), the Quality Working Party (QWP), the Modelling and Simulation Working Group (MSWG)) and external experts (the European Committee on Antimicrobial Susceptibility Testing (EUCAST)).
Danish: CHMP gennemgik i sin vurdering alle foreliggende data, herunder oplysninger indgivet af indehaverne af markedsføringstilladelse i løbet af proceduren, og rådførte sig med det pædiatriske udvalg (PDCO) og de relevante CHMP-arbejdsgrupper: arbejdsgruppen vedrørende smitsomme sygdomme (IDWP), arbejdsgruppen vedrørende farmakokinetik (PKWP), arbejdsgruppen vedrørende kvalitet (QWP), arbejdsgruppen vedrørende modellering og simulering (MSWG) samt eksterne eksperter (European
English: The Committee, as a consequence, concluded that the benefit-risk balance of the vancomycin containing products included in the scope of this procedure remains positive under normal conditions of use, taking into account the agreed changes to the product information.
Danish: konkluderede udvalget, at benefit/risk-forholdet for de af proceduren omfattede vancomycinholdige produkter fortsat er positivt ved normale anvendelsesbetingelser, forudsat at de vedtagne ændringer indføres i produktinformationen.
English: CHMP was of the opinion that, given the fact that the use of milligram to prescribe this product was established in EU clinical practice, it is essential that the convention of labelling vancomycin products by mass, i.e. milligrams, is retained.
Danish: Da det i EU er etableret praksis at ordinere dette produkt i mg, var CHMP af den opfattelse, at det er vigtigt at fastholde konventionen om at mærke produkter indeholdende vancomycin efter masse, dvs. mg.
English: • the CHMP carried out a benefit-risk evaluation of vancomycin containing products under Article 31 of Directive 2001/83/EC, reviewing all available data, including responses submitted by the marketing authorisation holders during the procedure and recommendations from the Paediatric Committee (PDCO), the CHMP relevant working parties/groups: Infectious Disease working party (IDWP), the Pharmacokinetics working party (PKWP), the Quality Working Party (QWP), the Modelling and Simulation Working Group (MSWG)) and external experts (the European Committee on Antimicrobial Susceptibility Testing (EUCAST),
Danish: • CHMP foretog en benefit/risk-vurdering af produkter indeholdende vancomycin i henhold til artikel 31 i direktiv 2001/83/EF med gennemgang af alle foreliggende data, herunder de ved proceduren indsendte besvarelser fra indehaverne af markedsføringstilladelserne samt anbefalinger fra det pædiatriske udvalg (PDCO) og de pågældende CHMP-arbejdsgrupper: arbejdsgruppen vedrørende smitsomme sygdomme (IDWP), arbejdsgruppen vedrørende farmakokinetik (PKWP), arbejdsgruppen vedrørende kvalitet (QWP), arbejdsgruppen vedrørende modellering og simulering (MSWG) og eksterne eksperter (European Committee on Antimicrobial Susceptibility Testing (EUCAST)) (det europæiske udvalg om bestemmelse af antimikrobiel følsomhed),
English: For both infants, children aged from one month to 18 years old, the CHMP agreed that, as for adults, the vancomycin dose should be individually adapted according to weight, age and the underlying type and severity of infection and clinical response; the initial vancomycin doses should be calculated based on the body weight.
Danish: For spædbørn og børn i alderen fra 1 måned til 18 år fandt CHMP, at dosis af vancomycin ligesom for voksne bør tilpasses individuelt efter vægt, alder, den underliggende infektions art og sværhedsgrad og den kliniske respons.
English: Current guidelines from the European Society of Clinical Microbiology and Infectious Diseases (ESCMID1,2) and Infectious Diseases Society of America (IDSA3) also support its role in the treatment of MRSA infections.
Danish: Dets rolle i behandlingen af MRSA-infektioner underbygges ligeledes af de gældende retningslinjer fra European Society of Clinical Microbiology and Infectious Diseases (ESCMID1,2) og Infectious Diseases Society of America (IDSA3).
English: • Treatment of: complicated skin and soft tissue infections, bone and joint infections, community acquired pneumonia, hospital acquired pneumonia including ventilator-associated pneumonia, infective endocarditis, bacteraemia that occurs in association with, or is suspected to be associated with any of the above (particularly those caused by methicillin-resistant Staphylococcus aureus (MRSA)), perioperative antibacterial prophylaxis.
Danish: • Behandling af: komplicerede hud- og bløddelsinfektioner, knogle- og ledinfektioner, samfundserhvervet pneumoni, nosokomiel pneumoni (herunder ventilationsrelateret), infektiøs endokarditis, bakteriæmi, der har sammenhæng med eller er mistænkt for at have sammenhæng med nogen af ovennævnte (navnlig dem, der er forårsaget af methicillinresistente Staphylococcus aureus (MRSA)), samt perioperativ antibakteriel profylakse.
English: • the CHMP considered that vancomycin represent a crucial therapeutic option in the context of the treatment of serious infections (complicated skin and soft tissue infections, bone and joint infections, community acquired pneumonia, hospital acquired pneumonia including ventilatorassociated pneumonia, infective endocarditis, acute bacterial meningitis, bacteraemia that occurs in association with, or is suspected to be associated with, any of the above, perioperative antibacterial prophylaxis, peritoneal dialysis-associated peritonitis and treatment of Clostridium difficile infection) caused by Gram-positive pathogens, particularly those caused by MRSA,
Danish: • CHMP vurderede, at vancomycin repræsenterer en behandlingsmulighed af afgørende betydning ved alvorlige infektioner (komplicerede hud- og bløddelsinfektioner, knogle- og ledinfektioner, samfundserhvervet pneumoni, nosokomiel pneumoni; herunder ventilationsrelateret, infektiøs endokarditis, akut bakteriel meningitis, bakteriæmi, der optræder i forbindelse med eller mistænkes for at være forbundet med nogen af ovennævnte, perioperativ antibakteriel profylakse, peritonealdialyserelateret peritonitis og behandling af infektioner med Clostridium difficile forårsaget af grampositive patogene organismer, især MRSA,
English: Furthermore, the CHMP noted that updated clinical guidelines for staphylococcal enterocolitis (diagnosis or treatment) do not mention this use of vancomycin.
Danish: CHMP bemærkede desuden, at denne anvendelse af vancomycin ikke nævnes i ajourførte kliniske retningslinjer vedrørende stafylokok-enterocolitis (diagnose eller behandling).
English: The guidance provides treatment recommendations for initial and recurrent CDI.
Danish: Vejledningen giver anbefalinger for behandling af initial og recidiverende infektion med Clostridium difficile.
English: 1 ESCMID guidelines: https://www.escmid.org/escmid_publications/medical_guidelines/escmid_guidelines/ 2 ESCMID guideline https://www.escmid.org/fileadmin/src/media/PDFs/4ESCMID_Library/2Medical_Guidelines/ESCMID_Guidelines/Eu_Rec_Antimicrobal.pdf 3 IDSA guideline http://www.idsociety.org/Guidelines/Patient_Care/IDSA_Practice_Guidelines/Antimicrobial_Agent_Use/Vancomycin/Vancomycin/ 4 Bacterial meningitis:ESCMID guideline for bacterial meningitis: http://www.clinicalmicrobiologyandinfection.com/article/S1198743X(16)00020-3/abstract
Danish: http://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(16)00020-3/abstract
English: Currently, there is no evidence that medical prophylaxis for CDI is efficacious and therefore there is not recommended prophylactic antibiotics.
Danish: https://www.britishinfection.org/files/5614/5674/2938/McGill_meningitis_guidelines_Final_published_proof.pdf profylakse af infektion med Clostridium difficile er effektiv, hvorfor der ikke anbefales nogen profylaktiske antibiotika.
English: It is currently made clear that TDM frequency needs to be individualised based on the clinical situation and response to treatment; specific recommendations are made for hemodynamically stable and unstable patients, patients with normal renal function and patients on intermittent haemodialysis.
Danish: Der er særlige anbefalinger for hæmodynamisk stabile og ustabile patienter, patienter med normal nyrefunktion og patienter i intermitterende hæmodialyse.
English: However, increases in the rates of heteroresistance and tolerance to vancomycin, combined with its pharmacodynamic (i.e. slow bactericidal activity, variable tissue penetration) and clinical (clinical failures reported in patients with invasive infections produced by Staphylococcus aureus with a MIC above 1 mcg/mL) shortcomings have questioned the current role of vancomycin for the treatment of these infections.
Danish: Vancomycins nuværende rolle i behandlingen af sådanne infektioner er dog blevet betvivlet på grund af en stigning i hyppigheden af heteroresistens og tolerance over for vancomycin, dets farmakodynamiske mangler (dvs. langsom baktericid aktivitet, forskelligartet vævspenetrering) og kliniske mangler (klinisk svigt indberettet hos patienter med invasive infektioner frembragt af Staphylococcus aureus med MIC over 1 µg/ml).
English: The CHMP noted that no update of the EUCAST breakpoints is warranted at this time.
Danish: CHMP bemærkede, at der på nuværende tidspunkt ikke behøves ajourføring af afskæringspunkterne i henhold til EUCAST (European Committee on Antimicrobial Susceptibility Testing) (den europæiske komité vedrørende antimikrobiel følsomhedsbestemmelse).
English: However, the CHMP noted that the 2 g/day dose often results in Ctrough values below the target of 10 to 20 mg/l; therefore in order to achieve the optimal target concentration, the CHMP agreed that the vancomycin dose should be individually adapted according to weight, age and the underlying type and severity of infection and clinical response; the initial vancomycin doses should be calculated based on the body weight.
Danish: For at opnå den optimale målkoncentration fandt CHMP derfor, at dosis af vancomycin bør tilpasses individuelt efter vægt, alder og underliggende art og sværhedsgrad af infektionen og den kliniske respons.
English: In view of the importance of ensuring the availability of efficacious antibiotics for the EU patients, in the interest of public health and in order to contribute to tackling the threat posed by the spread of antimicrobial resistance, a critical review of the benefit-risk of vancomycin containing products in the approved indications, including the relevant posology, was considered needed.
Danish: Det blev fundet påkrævet at foretage en kritisk gennemgang af benefit/risk-forholdet for produkter indeholdende vancomycin til de godkendte indikationer, herunder den pågældende dosering, på baggrund af vigtigheden af at sikre adgang til effektive antibiotika for patienter i EU, hensynet til folkesundheden og ønsket om at bidrage til imødegåelse af truslen fra udbredelsen af antimikrobiel resistens.
English: will enter into force, the limits of the impurities in the drug substance and final drug products will need to be revised accordingly, where applicable.
Danish: revidere grænserne for urenheder i det aktive stof og i de færdige præparater i overensstemmelse hermed.
English: 8 ISPD recommendations for paediatric patients (Warady BA et al., 2012) - https://ispd.org/media/pdf/Consensus__Change_20_.pdf 9https://www.escmid.org/fileadmin/src/media/PDFs/4ESCMID_Library/2Medical_Guidelines/ESCMID_Guidelines/fulltext_treatment_guidance_ Clostridium_difficile_infection.pdf
Danish: 2 ESCMID's retningslinjer https://www.escmid.org/fileadmin/src/media/PDFs/4ESCMID_Library/2Medical_Guidelines/ESCMID_Guidelines/Eu_Rec_Ant imicrobal.pdf
English: Once vancomycin monograph in the Ph.Eur.
Danish: Når Ph.Eur.-monografien for vancomycin træder i kraft, bliver det, hvor det er relevant, nødvendigt at
English: 10 Bauer MP. et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI).
Danish: Committee on Antimicrobial Susceptibility Testing (EUCAST)) (det europæiske udvalg om bestemmelse af antimikrobiel følsomhed).
English: Food enhances the absorption.
Danish: Mad fremskynder absorptionen.
English: 1210 Vienna
Danish: 1210 Wien
English: Each carton box contains 1 or 2 pipettes.
Danish: Hver æske indeholder 1 eller 2 pipetter.
English: Individual variation in Cmax and t1/2 was observed.
Danish: Der blev observeret individuel variation i Cmax og t1/2.
English: Date of first authorisation: 11/02/2014
Danish: Dato for første markedsføringstilladelse: 11/02/2014
English: If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth.
Danish: Hvis hunden ikke frivilligt indtager tabletten, kan den også gives sammen med mad eller direkte i munden.
English: Do not eat, drink or smoke while handling the product.
Danish: Spis, drik og ryg ikke samtidig med, at dette produkt håndteres.
English: Renal clearance is the minor route of elimination.
Danish: Renal udskillelse er den sekundære eliminationsvej.
English: Wash hands thoroughly with soap and water immediately after use of the product.
Danish: Vask hænderne grundigt med vand og sæbe straks efter håndtering af produktet.
English: No treatment-related clinical signs were observed.
Danish: Der sås ingen behandlingsrelaterede kliniske symptomer.
English: Hypersensitivity reactions to the product have been reported in a small number of people.
Danish: Overfølsomhedsreaktioner over for produktet er blevet rapporteret hos et lille antal personer.
English: Dimethylacetamide Glycofurol
Danish: Dimethylacetamid Glycofurol
English: The chewable tablets should not be broken or divided.
Danish: Tyggetabletterne må ikke knuses eller deles.
English: Major incompatibilities: None known.
Danish: Væsentlige uforligeligheder: Ingen kendte.
English: Lot:{number}
Danish: Lot: {nummer}
English: Use with caution in dogs with pre-existing epilepsy.
Danish: Skal anvendes med forsigtighed til hunde med allerede eksisterende epilepsi.
English: A plateau is seen in plasma between 7 and 63 days post administration, after which concentrations decline slowly.
Danish: Et forhøjet niveau ses i plasma fra 7 til 63 dage efter administration, hvorefter koncentrationerne falder langsomt.
English: Hypersensitivity reactions in humans have been reported.
Danish: Der er rapporteret om overfølsomhedsreaktioner hos mennesker.
English: Date of first authorisation: 11/02/2014 Date of last renewal:
Danish: Dato for første markedsføringstilladelse: 11/02/2014 Dato for seneste fornyelse af markedsføringtilladelse:
English: Pharmacotherapeutic group: Ectoparasiticides for systemic use.
Danish: Farmakoterapeutisk gruppe: Ectoparasiticider til systemisk brug.
English: Following oral administration, fluralaner is readily absorbed reaching maximum plasma concentrations within 1 day.
Danish: Efter oral administration absorberes fluralaner hurtigt, og maksimal plasmakoncentration nås inden for 1 dag.
English: Intervet UK Limited Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ United Kingdom
Danish: Intervet UK Limited Walton Manor, Walton Milton Keynes Buckinghamshire, MK7 7AJ Storbritannien
English: Strength and number of pipettes to be administered
Danish: Styrke og antal pipetter, der skal gives
English: The major route of elimination is the excretion of unchanged fluralaner in faeces (~90% of the dose).
Danish: Den primære eliminationsvej er udskillelse af uomdannet fluralaner i fæces (~90% af dosis).
English: Light to dark brown tablet with a smooth or slightly rough surface and circular shape.
Danish: Lysebrun til mørkebrun tablet med en glat eller let ru overflade og cirkulær form.
English: Intervet GesmbH Siemensstrasse 107 1210 Vienna AUSTRIA
Danish: Intervet GesmbH Siemensstrasse 107 1210 Wien Østrig
English: Incubation of fluralaner in the presence of carprofen or warfarin in dog plasma at maximum expected plasma concentrations did not reduce the protein binding of fluralaner, carprofen or warfarin.
Danish: Inkubation af fluralaner ved samtidig tilstedeværelse af carprofen eller warfarin i hundeplasma ved forventet maksimal plasmakoncentration reducerede ikke fluralaners, carprofens eller warfarins proteinbinding.
English: Do not wash or allow the dog to become immersed in water or swim in water courses within 3 days after treatment.
Danish: Hunden må ikke vaskes og skal afholdes fra at gå i vandet eller på anden måde udsættes for vand de første 3 dage efter behandlingen.
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af behov/risiko.
English: Strength and number of tablets to be administered
Danish: Styrke og antal tabletter, der skal indgives
English: Fluralaner is systemically distributed and reaches the highest concentrations in fat, followed by liver, kidney and muscle.
Danish: Fluralaner optages systemisk og når de højeste koncentrationer i fedt, efterfulgt af lever, nyrer og muskler.
English: Fluralaner is readily absorbed from the topical administration site into the hair, skin and subjacent tissues, from where it is slowly absorbed into the vascular system.
Danish: Fluralaner absorberes hurtigt fra det topikale administrationssted til pelsen, huden og underliggende væv, hvorfra det langsomt absorberes i det vaskulære system.
English: Bravecto is a chewable tablet and is well accepted by most dogs.
Danish: Bravecto er en tyggetablet, som de fleste hunde synes godt om.
English: Unchanged fluralaner is excreted in feces and to a very low extent in urine.
Danish: Uomdannet fluralaner udskilles i fæces og i meget lav grad i urinen.
English: and Rhipicephalus sanguineus) and fleas (Ctenocephalides spp.)
Danish: og Rhipicephalus sanguineus) og lopper (Ctenocephalides spp.)
English: Pregnancy, lactation and fertility:
Danish: Drægtighed, diegivning og fertilitet
English: The sachets should only be opened immediateley prior to use.
Danish: Brevene må først åbnes umiddelbart før brug.
English: The dog should be observed during administration to confirm that the tablet is swallowed.
Danish: Hunden bør iagttages under indgivelsen for at sikre, at den synker tabletten.
English: If skin contact does occur, wash the affected area immediately with soap and water.
Danish: I tilfælde af kontakt med huden skal området straks vaskes med vand og sæbe.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter forkortelsen 'EXP'.
English: Place the pipette tip vertically against the skin between the shoulder blades of the dog.
Danish: Placér pipettespidsen lodret på huden mellem hundens skulderblade.
English: Each ml contains 280 mg fluralaner.
Danish: 1 ml indeholder 280 mg fluralaner.
English: Pharmacotherapeutic group: Ectoparasiticides for systemic use ATCvet code: QP53B E02
Danish: Farmakoterapeutisk gruppe: Ectoparasiticider til systemisk brug ATCvet-kode: QP53BE02
English: Interaction with other medicinal products and other forms of interaction: None known.
Danish: Interaktion med andre lægemidler og andre former for interaktion Ingen kendte.
English: Care should be taken to avoid contact with the eyes of the animal.
Danish: Der skal træffes passende foranstaltninger for at undgå, at produktet kommer i kontakt med dyrets øjne.
English: The pipettes should be kept in the outer packaging to prevent solvent loss or moisture uptake.
Danish: Pipetterne skal opbevares i den ydre pakning for at undgå fordampning af solvensen eller optagelse af fugt.
English: The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Danish: Produktet kan anvendes som del af en behandlingsstrategi til kontrol af loppebetinget allergisk dermatitis (FAD).
English: Unit dose pipette made of laminated aluminium/polypropylene foil closed with an HDPE cap and packed in a laminated aluminium foil sachet.
Danish: Enkeltdosispipette fremstillet af lamineret aluminium/polypropylen-folie lukket med en HDPE-hætte og pakket i et lamineret aluminiumsfoliebrev.
English: Cardboard box with 1 aluminium foil blister sealed with PET aluminium foil lid stock containing 1, 2 or 4 chewable tablets.
Danish: Æske med 1 blisterkort af aluminiumsfolie, som er forseglet med PET aluminiumsfolielåg, med 1, 2 eller 4 tyggetabletter.
English: and fleas (Ctenocephalides spp.)
Danish: og lopper (Ctenocephalides spp.)
English: Make sure that your animal's application site is no longer noticeable before resuming contact with the site of application.
Danish: Det skal sikres, at applikationsstedet på dyret ikke længere er synligt, før applikationsstedet igen berøres.
English: Sodium lauryl sulfate Disodium embonate monohydrate Magnesium stearate Aspartame
Danish: Natriumlaurylsulfat Dinatriumembonatmonohydrat Magnesiumstearat Aspartam
English: For optimal control of flea infestation, the veterinary medicinal product should be administered at intervals of 12 weeks.
Danish: For at opnå optimal kontrol af loppeangreb skal veterinærlægemidlet administreres med 12 ugers interval.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Sikkerheden af veterinærlægemidlet under drægtighed og diegivning er ikke fastlagt.
English: Avoid the application of more than 1 ml of solution at any one spot as it could cause some of the solution to run or drip off the dog.
Danish: Undgå at påføre mere end 1 ml opløsning på et enkelt applikationssted, idet der ellers er risiko for, at noget af opløsningen vil løbe eller dryppe ned fra hunden.
English: Skin rashes tingling or numbness have been reported in a small number of individuals after skin contact.
Danish: Hududslæt, prikken eller følelsesløshed er rapporteret hos et lille antal personer efter hudkontakt.
English: Manufacturer responsible for batch release: Intervet GesmbH
Danish: Fremstiller ansvarlig for batchfrigivelse: Intervet GesmbH
English: Parasites need to start feeding on the host to become exposed to fluralaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded.
Danish: Parasitten skal have startet indtag af føde fra værten, før den udsættes for fluralaner; derfor kan risikoen for sygdomme overført fra parasitter ikke udelukkes.
English: Step 3: Squeeze the pipette gently and apply the entire contents directly to the dog's skin in one (when volume is small) or several spots along the dog's dorsal line from the shoulder to the base of the tail.
Danish: Trin 3: Klem forsigtigt på pipetten og påfør hele indholdet på et eller flere steder (afhængigt af mængden) direkte på hundens hud lang ryggens midterlinje fra skulderbladene til starten af halen.
English: It is efficacious against ticks (Ixodes spp., Dermacentor spp.
Danish: Det er effektivt mod flåter (Ixodes spp., Dermacentor spp.