Xeden Cat ad us. vet.

Hauptinformation

  • Handelsname:
  • Xeden® Cat ad us. vet., teilbare Tabletten
  • Darreichungsform:
  • teilbare Tabletten
  • 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:
  • Xeden® Cat ad us. vet., teilbare Tabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Antibiotikum (Gyrasehemmer) für Katzen

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 58882
  • Letzte Änderung:
  • 02-09-2017

Packungsbeilage

Xeden

Cat ad us. vet., teilbare Tabletten

Biokema SA

Antibiotikum (Gyrasehemmer) für Katzen

ATCvet: QJ01MA90

Zusammensetzung

Enrofloxacinum 15 mg, Aromatica, Excipiens pro Compresso.

Fachinformationen Wirkstoffe (CliniPharm)

Enrofloxacin

Eigenschaften / Wirkungen

Enrofloxacin ist ein synthetisches Antibiotikum aus der Familie der Fluorochinolone. Es

inhibiert die Topoisomerase II, ein Enzym welches im Mechanismus der

Bakterienreplikation eine Rolle spielt. Enrofloxacin besitzt eine konzentrationsabhängige

bakterizide Wirkung. Die inhibitorischen und die bakteriziden Konzentrationen liegen dicht

nebeneinander. Sie sind entweder identisch oder unterscheiden sich maximal um 1 -

2 Verdünnungsstufen. Enrofloxacin besitzt auch eine Wirkung gegen Bakterien in der

stationären Phase indem es die Permeabilität der äusseren Phospholipidschicht der

Bakterienzellwand verändert. Enrofloxacin ist im Allgemeinen aktiv gegen Gram negative

Bakterien (insbesondere Escherichia coli, Klebsiella spp., Proteus spp., Enterobacter spp.

und Pasteurella multocida), Mykoplasmen sowie gegen viele Gram positive Bakterien

(unter anderen Staphylococcus spp.).

Resistenzen gegenüber Enrofloxacin kommen vor. Pseudomonas aeruginosa kann rasch

durch eine Ein-Schritt-Resistenz unempfindlich werden. Im Allgemeinen ist die MHK höher

als bei anderen sensiblen Keimen.

Pharmakokinetik

Nach oraler Anwendung wird Enrofloxacin unabhängig vom Zeitpunkt der

Nahrungsaufnahme fast vollständig resorbiert. Enrofloxacin wird rasch zu einer aktiven

Verbindung, dem Ciprofloxacin, metabolisiert. Nach oraler Anwendung des Arzneimittels

(5 mg/kg) bei der Katze:

Wird die höchste Plasmakonzentration von Enrofloxacin (2.9 µg/ml) 1 Stunde nach der

Anwendung beobachtet.

Wird die höchste Plasmakonzentration von Ciprofloxacin (0.18 µg/ml) 5 Stunden nach der

Anwendung beobachtet.

Enrofloxacin besitzt ein grosses Verteilungsvolumen. Die Gewebekonzentrationen

übertreffen häufig diejenigen im Plasma. Enrofloxacin durchschreitet partiell die Blut-

Hirnschranke. Der an Plasmaproteine gebundene Anteil beträgt bei der Katze 8%, die

Plasmahalbwertszeit von Enrofloxacin (5 mg/kg) beträgt zwischen 5 und 7 Stunden.

Ungefähr 25% der Enrofloxacindosis werden über den Harn, 75% fäkal ausgeschieden.

Ungefähr 15% der Dosis wird unverändert ausgeschieden und der Rest in Form von

Metaboliten, darunter Ciprofloxacin (aktive Form). Die Gesamtclearance beträgt ungefähr

9 ml/Minute/kg Körpergewicht.

Indikationen

Behandlung von Infektionen verursacht durch Enrofloxacin empfindliche Keime bei der

Katze, insbesondere des Verdauungstraktes, der Atemwege und des Urogenitaltraktes

sowie der Haut und ebenso bei sekundären Infektionen von Verletzungen und bei Otitis

externa.

Oral.

5 mg Enrofloxacin pro kg Körpergewicht einmal täglich während 5 bis

10 aufeinanderfolgenden Tagen, d.h.:

-1 Tablette pro 3 kg Körpergewicht als einmalige tägliche Gabe.

oder ½ Tablette pro 1.5 kg Körpergewicht als einmalige tägliche

Gabe.

Falls nach der Hälfte der Behandlung keine klinische Besserung auftritt, muss die

Therapie neu überdacht werden.

Anzahl Tabletten

pro Tag

Gewicht der Katze

(kg)

1 ≤ - < 2

2 ≤ - < 4

4 ≤ - < 5

5 ≤ - < 6.5

6.5 ≤ - < 8.5

Die aromatisierten Tabletten können direkt ins Maul der Katze gegeben oder in die

Nahrung gemischt werden.

Anwendungseinschränkungen

Kontraindikationen:

Nicht anwenden bei Katzen jünger als 3 Monate oder mit einem Körpergewicht von unter

1 kg.

Bei hoher Dosierung besteht in der Wachstumsphase die Möglichkeit der Schädigung des

Epiphysenknorpels. Nicht anwenden bei Tieren mit zentralen Anfallsleiden. In klinischen

Studien an Labortieren (Ratten, Chinchillas) wurden nach Verabreichung von Enrofloxacin

in therapeutischer Dosierung keine foetotoxischen Effekte nachgewiesen.

Da Enrofloxacin in die Milch übergeht ist die Anwendung des Präparates bei der

laktierenden Katze kontraindiziert. Die Ausscheidung von Enrofloxacin erfolgt zum Teil

über die Niere. Bei bestehenden Nierenschäden ist daher, wie bei allen Fluorochinolonen,

mit einer Verzögerung der Ausscheidung zu rechnen.

Vorsichtsmassnahmen:

Xeden

Cat soll nur nach bakteriologischer Sicherung der Diagnose und

Sensitivitätsprüfung der beteiligten Erreger eingesetzt werden.

Der Einsatz von Xeden

Cat darf, wie der aller Fluorochinolone, aus Gründen einer

möglichen Resistenzentwicklung nicht zur Prophylaxe oder bei Bagatellinfektionen

erfolgen. Die vom Tierarzt verordnete Dosierung und Behandlungsdauer ist einzuhalten.

Da das Tierarzneimittel aromatisiert ist, besteht die Gefahr, dass Hunde und Katzen die

Tabletten gezielt aufsuchen und übermässig aufnehmen. Aus diesem Grund ist das

Präparat für Tiere unerreichbar aufzubewahren.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

In seltenen Fällen können gastrointestinale Störungen auftreten.

Wenn bei Katzen die empfohlene Dosierung überschritten wird, kann es zu retinotoxischen

Effekten einschliesslich Erblindung kommen.

Wechselwirkungen

Nicht gleichzeitig mit Tetrazyklinen, Substanzen aus der Chloramphenikolgruppe und

Makroliden anwenden.

Nicht gleichzeitig mit Theophyllin anwenden.

Die gleichzeitige Verabreichung von Produkten, welche Magnesium- oder Aluminiumsalze

enthalten kann die Resorption von Enrofloxacin vermindern.

Sonstige Hinweise

Ausserhalb der Reichweite von Kindern aufbewahren.

Bei Raumtemperatur (15 - 25 °C) lagern.

Aufbrauchfrist für halbierte Tabletten: 24 Stunden.

Das Medikament darf nur bis zu dem auf dem Behälter mit "Exp." bezeichneten Datum

verwendet werden.

Packungen

Packung zu 10 × 12 teilbaren Tabletten.

Abgabekategorie: A

Swissmedic Nr. 58'882

Informationsstand: 12/2016

Dieser Text ist behördlich genehmigt.

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Bovilis Blue-8 ad us. vet., Injektionssuspension fuer Rinder und Schafe

● Die Neuzulassung erfolgte am 04.09.2018.

Institut für Veterinärpharmakologie und toxikologie

31-8-2018

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use PremierZen Gold 4000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Easy 2 Slim contains hidden drug ingredient

Public Notification: Easy 2 Slim contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Easy 2 Slim, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Slimming Capsule contains hidden drug ingredients

Public Notification: Slimming Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Extenze Nutritional Supplement contains hidden drug ingredient

Public Notification: Extenze Nutritional Supplement contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Extenze Nutritional Supplement, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Extenze Plus contains hidden drug ingredient

Public Notification: Extenze Plus contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Extenze Plus, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: BodySlim Herbal contains hidden drug ingredient

Public Notification: BodySlim Herbal contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use BodySlim Herbal, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The US Food and Drug Administration (FD...

FDA - U.S. Food and Drug Administration

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

25-9-2018

Brilique (AstraZeneca AB)

Brilique (AstraZeneca AB)

Brilique (Active substance: ticagrelor) - PSUSA - Modification - Commission Decision (2018)6282 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1241/PSUSA/2948/201712

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

24-9-2018

Lumark (IDB Holland B.V.)

Lumark (IDB Holland B.V.)

Lumark (Active substance: lutetium, isotope of mass 177) - PSUSA - Modification - Commission Decision (2018)6212 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010391/201712

Europe -DG Health and Food Safety

19-9-2018

Stelara (Janssen-Cilag International NV)

Stelara (Janssen-Cilag International NV)

Stelara (Active substance: ustekinumab) - PSUSA - Modification - Commission Decision (2018)6102 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00003085/201712

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency