natgillin/translations-raw huggingface dataset:
• 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, 
• 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,
CHMP bemærkede desuden, at denne anvendelse af vancomycin ikke nævnes i ajourførte kliniske retningslinjer vedrørende stafylokok-enterocolitis (diagnose eller behandling). 
Furthermore, the CHMP noted that updated clinical guidelines for staphylococcal enterocolitis (diagnosis or treatment) do not mention this use of vancomycin.
Vejledningen giver anbefalinger for behandling af initial og recidiverende infektion med Clostridium difficile. 
The guidance provides treatment recommendations for initial and recurrent CDI.
http://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(16)00020-3/abstract 
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
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. 
Currently, there is no evidence that medical prophylaxis for CDI is efficacious and therefore there is not recommended prophylactic antibiotics.
Der er særlige anbefalinger for hæmodynamisk stabile og ustabile patienter, patienter med normal nyrefunktion og patienter i intermitterende hæmodialyse. 
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.
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). 
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.
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). 
The CHMP noted that no update of the EUCAST breakpoints is warranted at this time.
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. 
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.
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. 
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.
revidere grænserne for urenheder i det aktive stof og i de færdige præparater i overensstemmelse hermed. 
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.
2 ESCMID's retningslinjer https://www.escmid.org/fileadmin/src/media/PDFs/4ESCMID_Library/2Medical_Guidelines/ESCMID_Guidelines/Eu_Rec_Ant imicrobal.pdf 
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
Når Ph.Eur.-monografien for vancomycin træder i kraft, bliver det, hvor det er relevant, nødvendigt at 
Once vancomycin monograph in the Ph.Eur.
Committee on Antimicrobial Susceptibility Testing (EUCAST)) (det europæiske udvalg om bestemmelse af antimikrobiel følsomhed). 
10 Bauer MP. et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI).
Mad fremskynder absorptionen. 
Food enhances the absorption.
1210 Wien 
1210 Vienna
Hver æske indeholder 1 eller 2 pipetter. 
Each carton box contains 1 or 2 pipettes.
Der blev observeret individuel variation i Cmax og t1/2. 
Individual variation in Cmax and t1/2 was observed.
Dato for første markedsføringstilladelse: 11/02/2014 
Date of first authorisation: 11/02/2014
Hvis hunden ikke frivilligt indtager tabletten, kan den også gives sammen med mad eller direkte i munden. 
If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth.
Spis, drik og ryg ikke samtidig med, at dette produkt håndteres. 
Do not eat, drink or smoke while handling the product.
Renal udskillelse er den sekundære eliminationsvej. 
Renal clearance is the minor route of elimination.
Vask hænderne grundigt med vand og sæbe straks efter håndtering af produktet. 
Wash hands thoroughly with soap and water immediately after use of the product.
Der sås ingen behandlingsrelaterede kliniske symptomer. 
No treatment-related clinical signs were observed.
Overfølsomhedsreaktioner over for produktet er blevet rapporteret hos et lille antal personer. 
Hypersensitivity reactions to the product have been reported in a small number of people.
Dimethylacetamid Glycofurol 
Dimethylacetamide Glycofurol
Tyggetabletterne må ikke knuses eller deles. 
The chewable tablets should not be broken or divided.
Væsentlige uforligeligheder: Ingen kendte. 
Major incompatibilities: None known.
Lot: {nummer} 
Lot:{number}
Skal anvendes med forsigtighed til hunde med allerede eksisterende epilepsi. 
Use with caution in dogs with pre-existing epilepsy.
Et forhøjet niveau ses i plasma fra 7 til 63 dage efter administration, hvorefter koncentrationerne falder langsomt. 
A plateau is seen in plasma between 7 and 63 days post administration, after which concentrations decline slowly.
Der er rapporteret om overfølsomhedsreaktioner hos mennesker. 
Hypersensitivity reactions in humans have been reported.
Dato for første markedsføringstilladelse: 11/02/2014 Dato for seneste fornyelse af markedsføringtilladelse: 
Date of first authorisation: 11/02/2014 Date of last renewal:
Farmakoterapeutisk gruppe: Ectoparasiticider til systemisk brug. 
Pharmacotherapeutic group: Ectoparasiticides for systemic use.
Efter oral administration absorberes fluralaner hurtigt, og maksimal plasmakoncentration nås inden for 1 dag. 
Following oral administration, fluralaner is readily absorbed reaching maximum plasma concentrations within 1 day.
Intervet UK Limited Walton Manor, Walton Milton Keynes Buckinghamshire, MK7 7AJ Storbritannien 
Intervet UK Limited Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ United Kingdom
Styrke og antal pipetter, der skal gives 
Strength and number of pipettes to be administered
Den primære eliminationsvej er udskillelse af uomdannet fluralaner i fæces (~90% af dosis). 
The major route of elimination is the excretion of unchanged fluralaner in faeces (~90% of the dose).
Lysebrun til mørkebrun tablet med en glat eller let ru overflade og cirkulær form. 
Light to dark brown tablet with a smooth or slightly rough surface and circular shape.
Intervet GesmbH Siemensstrasse 107 1210 Wien Østrig 
Intervet GesmbH Siemensstrasse 107 1210 Vienna AUSTRIA
Inkubation af fluralaner ved samtidig tilstedeværelse af carprofen eller warfarin i hundeplasma ved forventet maksimal plasmakoncentration reducerede ikke fluralaners, carprofens eller warfarins proteinbinding. 
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.
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. 
Do not wash or allow the dog to become immersed in water or swim in water courses within 3 days after treatment.
Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af behov/risiko. 
Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Styrke og antal tabletter, der skal indgives 
Strength and number of tablets to be administered
Fluralaner optages systemisk og når de højeste koncentrationer i fedt, efterfulgt af lever, nyrer og muskler. 
Fluralaner is systemically distributed and reaches the highest concentrations in fat, followed by liver, kidney and muscle.
Fluralaner absorberes hurtigt fra det topikale administrationssted til pelsen, huden og underliggende væv, hvorfra det langsomt absorberes i det vaskulære system. 
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.
Bravecto er en tyggetablet, som de fleste hunde synes godt om. 
Bravecto is a chewable tablet and is well accepted by most dogs.
Uomdannet fluralaner udskilles i fæces og i meget lav grad i urinen. 
Unchanged fluralaner is excreted in feces and to a very low extent in urine.
og Rhipicephalus sanguineus) og lopper (Ctenocephalides spp.) 
and Rhipicephalus sanguineus) and fleas (Ctenocephalides spp.)
Drægtighed, diegivning og fertilitet 
Pregnancy, lactation and fertility:
Brevene må først åbnes umiddelbart før brug. 
The sachets should only be opened immediateley prior to use.
Hunden bør iagttages under indgivelsen for at sikre, at den synker tabletten. 
The dog should be observed during administration to confirm that the tablet is swallowed.
I tilfælde af kontakt med huden skal området straks vaskes med vand og sæbe. 
If skin contact does occur, wash the affected area immediately with soap and water.
Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter forkortelsen 'EXP'. 
Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Placér pipettespidsen lodret på huden mellem hundens skulderblade. 
Place the pipette tip vertically against the skin between the shoulder blades of the dog.
1 ml indeholder 280 mg fluralaner. 
Each ml contains 280 mg fluralaner.
Farmakoterapeutisk gruppe: Ectoparasiticider til systemisk brug ATCvet-kode: QP53BE02 
Pharmacotherapeutic group: Ectoparasiticides for systemic use ATCvet code: QP53B E02
Interaktion med andre lægemidler og andre former for interaktion Ingen kendte. 
Interaction with other medicinal products and other forms of interaction: None known.
Der skal træffes passende foranstaltninger for at undgå, at produktet kommer i kontakt med dyrets øjne. 
Care should be taken to avoid contact with the eyes of the animal.
Pipetterne skal opbevares i den ydre pakning for at undgå fordampning af solvensen eller optagelse af fugt. 
The pipettes should be kept in the outer packaging to prevent solvent loss or moisture uptake.
Produktet kan anvendes som del af en behandlingsstrategi til kontrol af loppebetinget allergisk dermatitis (FAD). 
The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Enkeltdosispipette fremstillet af lamineret aluminium/polypropylen-folie lukket med en HDPE-hætte og pakket i et lamineret aluminiumsfoliebrev. 
Unit dose pipette made of laminated aluminium/polypropylene foil closed with an HDPE cap and packed in a laminated aluminium foil sachet.
Æske med 1 blisterkort af aluminiumsfolie, som er forseglet med PET aluminiumsfolielåg, med 1, 2 eller 4 tyggetabletter. 
Cardboard box with 1 aluminium foil blister sealed with PET aluminium foil lid stock containing 1, 2 or 4 chewable tablets.
og lopper (Ctenocephalides spp.) 
and fleas (Ctenocephalides spp.)
Det skal sikres, at applikationsstedet på dyret ikke længere er synligt, før applikationsstedet igen berøres. 
Make sure that your animal's application site is no longer noticeable before resuming contact with the site of application.
Natriumlaurylsulfat Dinatriumembonatmonohydrat Magnesiumstearat Aspartam 
Sodium lauryl sulfate Disodium embonate monohydrate Magnesium stearate Aspartame
For at opnå optimal kontrol af loppeangreb skal veterinærlægemidlet administreres med 12 ugers interval. 
For optimal control of flea infestation, the veterinary medicinal product should be administered at intervals of 12 weeks.
MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Sikkerheden af veterinærlægemidlet under drægtighed og diegivning er ikke fastlagt. 
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
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. 
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.
Hududslæt, prikken eller følelsesløshed er rapporteret hos et lille antal personer efter hudkontakt. 
Skin rashes tingling or numbness have been reported in a small number of individuals after skin contact.
Fremstiller ansvarlig for batchfrigivelse: Intervet GesmbH 
Manufacturer responsible for batch release: Intervet GesmbH
Parasitten skal have startet indtag af føde fra værten, før den udsættes for fluralaner; derfor kan risikoen for sygdomme overført fra parasitter ikke udelukkes. 
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.
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. 
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.
Det er effektivt mod flåter (Ixodes spp., Dermacentor spp. 
It is efficacious against ticks (Ixodes spp., Dermacentor spp.
Oral optagelse af produktet ved den højeste anbefalede dosis tolereredes godt hos katte bortset fra nogle selvbegrænsende tilfælde af savlen og hoste eller opkastning umiddelbart efter påføring. 
Oral uptake of the product at the maximum recommended dose was well tolerated in cats, apart from some self-limiting salivation and coughing or vomiting immediately after administration.
Trin 2: Hunden skal stå eller ligge med ryggen i vandret stilling under påføringen. 
Step 2: The dog should be standing or lying with its back horizontal during application.
Oral optagelse af produktet ved den højeste anbefalede dosis på 93 mg fluralaner/kg kropsvægt tolereredes godt hos katte bortset fra nogle selvbegrænsende tilfælde af savlen og hoste eller opkastning umiddelbart efter påføring. 
Oral uptake of the product at the maximum recommended dose of 93 mg fluralaner/kg body weight was well tolerated in cats, apart from some self-limiting salivation and coughing or vomiting immediately after administration.
Opbevar produktet i den originale emballage indtil brug for at undgå, at børn får direkte adgang til produktet. 
Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
1 tyggetablet 2 tyggetabletter 4 tyggetabletter 
1 chewable tablet 2 chewable tablets 4 chewable tablets
Lopper og flåter skal bide sig fast på værten og starte indtag af føde, før de udsættes for det aktive stof. 
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Opbevar produktet i den originale emballage indtil brug for at undgå, at børn får adgang til produktet. 
Keep the product in the original packaging until use in order to prevent children from getting access to the product.
Fluralaner har en høj bindingsgrad til plasmaproteiner og kan muligvis konkurrere med andre stærkt bundne aktive stoffer såsom non-steroide anti-inflammatoriske (NSAID) præparater og kumarinderivatet warfarin. 
Fluralaner is highly bound to plasma proteins and might compete with other highly bound active substances such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin.
Kramper og letargi er rapporteret i meget sjældne tilfælde i spontane indberetninger. 
Convulsions and lethargy has been reported very rarely in spontaneous reports.
I in vitro-bioassays påvirkes fluralaner ikke af påvist resistens over for amidiner (flåt), organophosphater (flåt, mide), cyclodiener (flåt, loppe, flue), makrocykliske laktoner (havlus), phenylpyrazoler (flåt, loppe ), benzophenyl urinstoffer (flåt), pyrethroider (flåt, mide) og carbamater (mide). 
In in vitro bio-assays, fluralaner is not affected by proven field resistances against amidines (tick), organophosphates (tick, mite), cyclodienes (tick, flea, fly), macrocyclic lactones (sea lice), phenylpyrazoles (tick, flea), benzophenyl ureas (tick), pyrethroids (tick, mite) and carbamates (mite).
EXP: {MM/ÅÅÅÅ} 
EXP: (MM/YYYY)
Hyppigheden af bivirkninger er defineret som: - meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter). 
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Hver Bravecto tyggetablet indeholder: 
Each chewable tablet of Bravecto contains:
på katte. 
on the cat.
Behandlingsskema: 
Treatment schedule:
Følgende andre ikke almindelige symptomer er observeret kort efter påføring: apati, tremor og anoreksi (0,9 % af behandlede katte) eller opkastning og hypersalivation (0,4 % af behandlede katte). 
The following other signs shortly after administration were uncommonly observed: apathy/tremors/anorexia (0.9% of treated cats) or vomiting/hypersalivation (0.4% of treated cats).
Det er effektivt mod flåter (Ixodes spp.) 
It is efficacious against ticks (Ixodes spp.)
Kattens vægt (kg) 
Bodyweight of cat (kg)
Drægtighed, laktation og fertilitet: Dette veterinærlægemiddel kan anvendes til avlshunde samt drægtige og diegivende hunde. 
Pregnancy, lactation and fertility: The veterinary medicinal product can be used in breeding, pregnant and lactating dogs.
Der kan forekomme synlig marmorering og/eller prikker. 
Some marbling, speckles or both may be visible.
Produktet anvendes ved at påføre indholdet i nakken, helt oppe hvor man kan mærke, kraniet slutter: for katte med en kropsvægt på op til 6,25 kg påføres indholdet på ét enkelt sted og for katte med en kropsvægt på over 6,25 kg på to steder. 
The product should be applied on cats up to 6.25 kg body weight in one spot at the base of the skull and in two spots on cats greater than 6.25 kg bodyweight.
Produktet bør ikke administreres hyppigere end med 8 ugers interval, da sikkerheden ved kortere intervaller ikke er blevet testet. 
The product should not be administered at intervals shorter than 8 weeks as the safety at shorter intervals has not been tested.
Hold om pipetten i bunden, der hvor den er sammensvejst, eller omkring den hårde del lige under hætten i oprejst stilling (spidsen skal vende opad), når den åbnes. 
The pipette should be held by the base or by the upper rigid portion below the cap in an upright position (tip up) for opening it.
på hunde. 
on the dog.
Indgiv Bravecto tyggetabletter på fodringstidspunktet eller umiddelbart før eller efter. 
Administer Bravecto chewable tablets at or around the time of feeding.
Sikkerhed er påvist hos avlshunde samt drægtige og diegivende hunde, som blev behandlet med en overdosis på op til 3 gange den anbefalede højeste dosis. 
Safety was demonstrated in breeding, pregnant and lactating animals treated with overdoses of up to 3 times the maximum recommended dose.
Hætten kan ikke tages af. 
Cap does not come off.
Der sås ingen indvirkning på reproduktionsevnen og ingen indvirkning af betydning på hvalpes levedygtighed, når fluralaner blev administreret oralt til Beagle-hunde ved en overdosis op til 3 gange den maksimalt anbefalede dosis (op til 168 mg/kg kropsvægt fluralaner). 
There were no findings on reproductive performance and no findings of concern on offspring viability when fluralaner was administered orally to Beagle dogs at overdoses of up to 3 times the maximum recommended dose (up to 168 mg/kg bodyweight of fluralaner).
Til behandling af flåt- og loppeangreb hos katte. 
For the treatment of tick and flea infestations in cats.