Advocid 18% ad us. vet.

Hauptinformation

  • Handelsname:
  • Advocid® 18% ad us. vet., Injektionslösung
  • Darreichungsform:
  • Injektionslösung
  • Verwenden für:
  • Tiere
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Advocid® 18% ad us. vet., Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Antibiotikum (Gyrasehemmer) für Rinder

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 53122
  • Letzte Änderung:
  • 02-09-2017

Packungsbeilage

Advocid

18% ad us. vet., Injektionslösung

Zoetis Schweiz GmbH

Antibiotikum (Gyrasehemmer) für Rinder

ATCvet: QJ01MA92

Zusammensetzung

Danofloxacin 180 mg ut danofloxacini mesilas, 2-pyrrolidinonum, povidonum, magnesii

oxidum ponderosum. Antiox.: 3-mercapto-1,2-propandiolum 5 mg. Conserv.: phenolum

2.5 mg, aqua ad iniectabilia q.s. ad solutionem pro 1 ml.

Fachinformationen Wirkstoffe (CliniPharm)

Danofloxacin

Eigenschaften / Wirkungen

Danofloxacin ist ein Breitspektrum-Antibiotikum aus der Gruppe der synthetischen

Fluoroquinolone. Es besitzt eine starke in vitro Aktivität gegen pathogene Keime, welche

häufig bei Atemwegs-, und Durchfallerkrankungen sowie bei der akuten Mastitis des

Rindes vorkommen, nämlich Pasteurella haemolytica, Pasteurella multocida, Histophilus

somni (früher Haemophilus somnus) und Escherichia coli.

Sensible Erreger gegen Danofloxacin:

Mikroorganismen

MIC

90

mcg/ml

Pasteurella haemolytica 0.25

Pasteurella multocida

0.06

Histophilus somni

0.06

Escherichia coli

0.12

Mykoplasma bovis

0.25

Danofloxacin entfaltet seine Aktivität durch Hemmung bakterieller DNA-Gyrasen, welche

an der DNA-Replikation beteiligt sind. Die inhibitorische Wirkung erfolgt während des

zweiten enzymatischen Prozesses, indem die Funktionen der Teilung und der

Wiederverschliessung verhindert werden. Danofloxacin bildet, wie andere Quinolone,

einen stabilen Komplex zwischen Enzym und DNA. Dadurch werden sowohl Replikation

als auch Transkription verunmöglicht. Dieser Mechanismus hat eine schnelle bakterizide

Wirkung zur Folge.

Pharmakokinetik

Danofloxacin wird schnell vom Injektionsort resorbiert und erreicht hohe Wirkstoffspiegel

im Lungen-, Dünndarm- und lymphatischem Gewebe. Nach subkutaner

Einzelverabreichung von 6 mg/kg Körpergewicht, werden innerhalb von 1 - 2 Stunden

Höchstkonzentrationen in Plasma und Gewebe erreicht. Dabei werden in Lungen- und

gastrointestinalem Gewebe viermal höhere Konzentrationen gemessen als im Plasma. In

Lungen- und gastrointestinalem Gewebe liegen die Höchstkonzentrationen von

Danofloxacin mindesten 25-mal höher als die MHK

Werte der meisten pathogenen

Keime, welche für respiratorische oder enterale Infektionen relevant sind; für eine

bakterizide Wirkung von Advocid 18% werden dadurch optimale Verhältnisse erreicht.

Acht bzw. 24 Stunden nach einer subkutanen Einzelinjektion betragen die

durchschnittlichen Konzentrationen von Danofloxacin in der Milch 4.61 bzw. 0.2 μg/ml.

Indikationen

Atemwegserkrankungen, verursacht durch Pasteurella haemolytica, Pasteurella multocida

und Histophilus somni (früher Haemophilus somnus), bei Kälbern, Rindern und Kühen.

Akute Mastitis verursacht durch Danofloxacin-empfindliche Escherichia coli, bei Rindern

und Kühen.

Durchfallerkrankungen, verursacht durch Escherichia coli, bei Kälbern.

Subkutane oder intravenöse Einzelinjektion von 6 mg/kg Körpergewicht (1 ml/30 kg KGW).

Falls erforderlich kann 48 Stunden nach der ersten Injektion eine weitere Dosis von

6 mg/kg KGW verabreicht werden.

Bei Rindern über 450 kg KGW soll bei subkutaner Injektion pro Injektionsstelle nicht mehr

als 15 ml appliziert werden.

Bei Mehrfachentnahme wird eine Aspirationsnadel empfohlen, um ein übermässiges

Eröffnen des Gummistopfens zu vermeiden.

Anwendungseinschränkungen

Kontraindikationen:

Vorliegende Resistenz gegenüber Chinolonen, da gegenüber diesen eine nahezu

vollständige, gegenüber anderen Fluorochinolone eine komplette Kreuzresistenz besteht.

Vorsichtsmassnahmen:

Fluorochinolone können den Gelenkknorpel schädigen. Die Dosierungsanweisungen

sollen daher genau beachtet werden.

Advocid 18% Injektionslösung soll nur nach vorheriger bakteriologischer Sicherung der

Diagnose und Sensitivitätsprüfung der beteiligten Erreger sowie bei Vorliegen von

Resistenzen gegnüber anderen Antibiotika angewendet werden. Der Einsatz von Advocid

18%, wie der aller Fluorochinolone, sollte aus Gründen einer möglichen

Resistenzentwicklung nicht bei geringfügigen Injektionen erfolgen.

In Fällen, in denen zu Beginn der Behandlung nicht auszuschliessen ist, dass eine

perakute Mastitis auf einer Infektion mit S. aureus beruht, ist zusätzlich eine

intramammäre Therapie gegen grampositive Erreger erforderlich.

Die Unbedenklichkeit von Danofloxacin wurde bei trächtigen Kühen und Zuchtbullen nicht

spezifisch überprüft.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

In sehr seltenen Fällen können bei empfindlichen Tieren nach der Injektion sofortige oder

verzögerte anaphylaktische Reaktionen auftreten. Lokale Reaktionen an der

Injektionsstelle kommen vor und sind vorübergehender Natur.

Essbare Gewebe:Kalb

8 Tage

Rinder, Kühe3 Tage

Milch:

4 Tage

Wechselwirkungen

Bei Kombination von Advocid ad us. vet. mit Makroliden oder Tetrazyklin ist mit

antagonistischen Effekten zu rechnen.

Sonstige Hinweise

Nach Gebrauch Hände waschen.

Bei Augenkontakt, Augen mit viel Wasser auswaschen.

Vor Licht geschützt und unter 30°C aufbewahren. Nicht gefrieren lassen. Aufbrauchfrist

nach erster Entnahme: 28 Tage.

Beim Öffnen Kontamination vermeiden. Haltbarkeit: Das Medikament darf nur bis zu dem

auf dem Behälter mit "Exp." bezeichneten Datum verwendet werden.

Ausserhalb der Reichweite von Kindern aufbewahren.

Packungen

Flaschen zu 50 ml und 100 ml

Abgabekategorie: A

Swissmedic Nr. 53'122

Informationsstand: 11/2007

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28-8-2018

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (Active substance: Bertilimumab) - Orphan designation - Commission Decision (2018)5740 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2066 (Incyte Biosciences Distribution B.V.)

EU/3/18/2066 (Incyte Biosciences Distribution B.V.)

EU/3/18/2066 (Active substance: Pemigatinib) - Orphan designation - Commission Decision (2018)5736 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2065 (SFL Regulatory Services GmbH)

EU/3/18/2065 (SFL Regulatory Services GmbH)

EU/3/18/2065 (Active substance: Obiltoxaximab) - Orphan designation - Commission Decision (2018)5735 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/080/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Active substance: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene) - Orphan designation - Commission Decision (2018)5732 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2059 (IntraBio Ltd)

EU/3/18/2059 (IntraBio Ltd)

EU/3/18/2059 (Active substance: Acetylleucine) - Orphan designation - Commission Decision (2018)5731 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/095/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2064 (Bayer AG)

EU/3/18/2064 (Bayer AG)

EU/3/18/2064 (Active substance: Copanlisib) - Orphan designation - Commission Decision (2018)5734 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/071/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2069 (Professor Marjukka MyllArniemi)

EU/3/18/2069 (Professor Marjukka MyllArniemi)

EU/3/18/2069 (Active substance: Tilorone) - Orphan designation - Commission Decision (2018)5738 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/18

Europe -DG Health and Food Safety