natgillin/translations-raw huggingface dataset:
Kontinuerlig infusion af vancomycin har imidlertid visse ulemper, såsom eventuelle kompatibilitetsproblemer med andre intravenøse lægemidler eller samtidigt indgivne opløsninger, praktiske problemer relateret til nedsat tilgængelighed af infusionsslangen, når der infunderes gennem 24 timer, og øget risiko for infusion af en bolusdosis af vancomycin, når den intravenøse opløsning skiftes, eller når et andet lægemiddel infunderes i samme infusionsslange, der er fyldt med vancomycin 24 timer i døgnet mv.
However, continuous vancomycin infusions have a few disadvantages such as that there may be compatibility issues with other IV medications or solutions that are given concurrently; practical problems associated with reduced line availability when infusions are given over a 24-h period; increased risk of infusing a bolus dose of vancomycin when the intravenous solution is changed or when another medication is infused into the same intravenous tubing which is filled with vancomycin 24 h/day etc.
CHMP gennemgik desuden dosisanbefalingen for den pædiatriske population.
The CHMP also reviewed the dose recommendation in paediatric population.
• Hvad angår "dekontaminering af mave-tarm-kanalen hos immunkompromitterede patienter i kombination med et aminoglykosid", gennemgik CHMP de foreliggende data, der var indsendt under proceduren.
• Concerning the “decontamination of the GI tract in immune-compromised patients when combined with an aminoglycoside”, the CHMP reviewed the available data submitted throughout this procedure.
CHMP anerkendte, at de gældende terapeutiske retningslinjer understreger vigtigheden af terapeutisk lægemiddelovervågning og anvendelse af dal-koncentrationen af vancomycin som surrogat for det tilstræbte AUC.
The CHMP acknowledged that the current therapeutic guidelines stress the importance of therapeutic drug monitoring and the use of the trough vancomycin concentration as a surrogate for the target AUC.
Dets hovedsagelig baktericide virkning udøves i det væsentlige ved hæmning af peptidoglycan-syntesen til cellevæggene.
Its effect is mainly bactericidal and it is exerted mainly by the inhibition of the cell wall peptidoglycan synthesis.
• Behandling af infektion med Clostridium difficile (CDI) ved oral administration af vancomycin.
• Treatment of Clostridium difficile infection (CDI), for vancomycin given by oral route of administration.
• CHMP fandt, at de iagttagne risici for nefrotoksicitet, ototoksicitet, infusionsrelaterede bivirkninger og overfølsomhedsreaktioner med vancomycin til intravenøs anvendelse kan minimeres gennem passende advarsler og anbefalinger i produktinformationen,
• the CHMP considered that the risks of nephrotoxicity, ototoxicity, infusion related adverse reactions and hypersensitivity reactions observed with vancomycin for intravenous use can be minimised by appropriate warnings and recommendations in the product information,
Efter at have gennemgået de data, som indehaverne af markedsføringstilladelserne havde fremlagt, tog CHMP dog også hensyn til de begrænsninger, som overvågning af dal-koncentrationen har i visse situationer.
However, having reviewed the data presented by the MAHs, the CHMP also considered the existing limitations of monitoring Ctrough in certain situations.
CHMP bemærkede, at de gældende retningslinjer for behandling af akut bakteriel meningitis fra en række videnskabelige selskaber (ESCMID4, IDSA5, UK joint specialist societies 6 og European Federation Neurological Societies (EFNS)) anbefaler vancomycin til både empirisk og ætiologisk behandling af MRSA (alene) og til penicillinresistente Streptococcus pneumoniae (PRSP) i kombination med andre antibakterielle midler hos voksne og børn.
The CHMP noted that the current guidelines for the treatment of acute bacterial meningitis from several learned societies (ESCMID4, IDSA5 guideline and UK joint specialist societies guidelines6, European Federation Neurological Societies (EFNS)) recommend vancomycin for both empirical treatment and etiological treatment of MRSA (alone) and penicillin-resistant Streptococcus pneumoniae (PRSP) in combination with other antibacterials in adults and children.
CHMP gennemgik også den optimale måde at angive styrke og dosis på for produkter indeholdende vancomycin.
The CHMP reviewed also the optimal way of expressing the strength and dose of vancomycincontaining products.
Det hyppigst anvendte doseringsregime (1 g hver 12. time) blev af CHMP anset for passende i farmakokinetisk og farmakodynamisk henseende for de fleste patienter med normal nyrefunktion og baseret på stafylokokkers sædvanlige følsomhed (mindste hæmmende koncentration (MIC) ≤ 1 mg/l).
The most commonly used dosage regimen (1 g every 12 hours) was considered adequate by the CHMP from a pharmacokinetic and pharmacodynamic perspective for the majority of patients with normal renal function and based on the usual susceptibility of staphylococci (minimum inhibitory concentration (MIC) ≤1 mg/L).
Som følge heraf kunne CHMP ikke give konkrete doseringsanbefalinger for kontinuerlig infusion i produktresuméet for vancomycin til intravenøs anvendelse.
As a consequence, the CHMP could not recommend any concrete dosing recommendations for continuous infusion in the SmPC of vancomycin for IV use.
• CHMP fandt de foreliggende data tilstrækkelige som grundlag for revision af indikationerne for lægemidler til både oral og parenteral anvendelse og for revision af doseringen til voksne og pædiatriske populationer i henhold til de kliniske erfaringer og gældende behandlingsvejledninger,
• the CHMP considered the available data to be sufficient to support revisions of the indication for both oral use and parenteral use, as well as the posology in adults and paediatrics populations, in line with clinical experience and current therapeutic guidelines,
CHMP gennemgik også de eksisterende data om observerede bivirkninger ved anvendelse af vancomycin, og som bekræfter, at parenteral anvendelse af vancomycin er forbundet med nefrotoksicitet og ototoksicitet, infusionsrelaterede bivirkninger såsom toksisk virkning på vener og væv samt hypersensitivitetsreaktioner.
The CHMP also reviewed the existing data on adverse reactions observed with the use of vancomycin and which confirm that the use of vancomycin for parenteral use is associated with nephrotoxicity and ototoxicity, infusion related adverse reactions like vein and tissue toxicity as well as hypersensitivity reactions.
CHMP diskuterede derfor en række andre metoder til at beregne eksponeringen for vancomycin.
Therefore, the CHMP discussed different alternative approaches to estimate the vancomycin exposure.
CHMP anerkendte også, at der for visse allerede godkendte lægemidler indeholdende vancomycin i forvejen er medtaget visse doseringsanbefalinger for både fuldbårne og præmature nyfødte7.
The CHMP also acknowledged that some already approved vancomycin containing medicines already include some dosing recommendations for both term and preterm neonates11.
Intravenøst vancomycin anvendes hovedsagelig til behandling af alvorlige infektioner forårsaget af mikroorganismer med resistensmekanismer over for β-lactamantibiotika, især methicillinresistente Staphylococcus aureus (MRSA), koagulase-negative stafylokokker (CoNS) og enterokokker, som ofte er tolerante over for β-lactamantibiotika.
Intravenous vancomycin is mainly used for the treatment of serious infections caused by microorganisms with mechanisms of resistance to beta-lactam antibiotics, in particular methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CoNS) and enterococci, the latter being often tolerant to β-lactam antibiotics.
Følgende indikationer for vancomycin (oralt) til "Behandling af stafylokok-enterocolitis" og " dekontaminering af mave-tarm-kanalen hos immunkompromitterede patienter i kombination med et aminoglykosid," støttedes ikke af CHMP:
The following indications of vancomycin (oral route) for “treatment of staphylococcal enterocolitis” and “Decontamination of the gastrointestinal (GI) tract in immune-compromised patients when combined with an aminoglycoside” were not supported by the CHMP:
Ved lettere, klart antibiotikaforårsagede infektioner med Clostridium difficile kan det accepteres at seponere det inducerende antibiotikum og iagttage den kliniske respons.
In the case of mild CDI clearly induced by the use of antibiotics, it is acceptable to discontinue the inducing antibiotic and observe the clinical response.
CHMP er følgelig af den opfattelse, at benefit/risk-forholdet for produkter indeholdende vancomycin til indikationen "dekontaminering af mave-tarm-kanalen hos immunkompromitterede patienter i kombination med et aminoglykosid" ikke er fastlagt, hvorfor denne indikation ikke anbefales.
As a consequence, the CHMP is of the view that the benefit-risk for vancomycin containing products in the indication “Decontamination of the gastrointestinal tract in immune-compromised patients when combined with an aminoglycoside” is not established and therefore this indication is not recommended.
CHMP gennemgik desuden den evidens, der er forelagt i forbindelse med referralproceduren, og som bekræfter vancomycins virkning ved behandling af peritonitis ved peritonealdialyse, herunder en række litteraturhenvisninger og en metaanalyse af i alt 64 studier (32 vedrørende indledende behandling og negativ dyrkning, 28 vedrørende behandling for grampositive og 24 vedrørende behandling for gramnegative) og 21 randomiserede kliniske studier (14 vedrørende initial behandling og negativ dyrkning, 8 vedrørende behandling for grampositive og 8 vedrørende behandling for gramnegative).
In addition, the CHMP reviewed the available evidence submitted within the referral procedure including several references to published literature and a meta-analysis of a total of 64 studies (32 for initial treatment and negative culture, 28 reporting treatment for Gram-positive and 24 reporting treatment for Gram-negative) and 21 randomized clinical trials (14 for initial treatment and negative culture, 8 reporting treatment for Gram-positive and 8 reporting treatment for Gram-negative), confirming the efficacy of vancomycin for the treatment of peritonitis in peritoneal dialysis.
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.
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.
CHMP har tilsvarende ændret ordlyden om terapeutisk lægemiddelovervågning i punkt 4.2 af produktresuméet.
The wording on therapeutic drug monitoring in section 4.2 of the SmPC has been amended accordingly by the CHMP.
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
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)).
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.
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.
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.
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.
• 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),
• 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),
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.
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.
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).
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.
• 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.
• 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.
• 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.