Vetmedin 10 mg ad us. vet.

Hauptinformation

  • Handelsname:
  • Vetmedin® 10 mg ad us. vet., Kautabletten
  • Darreichungsform:
  • Kautabletten
  • 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:
  • Vetmedin® 10 mg ad us. vet., Kautabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Kardiovaskuläres Therapeutikum beim Hund

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 57804
  • Letzte Änderung:
  • 02-09-2017

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Vetmedin

10 mg ad us. vet., Kautabletten

PDF-Version:

Deutsch

Français

Boehringer Ingelheim (Schweiz) GmbH

Kardiovaskuläres Therapeutikum beim Hund

ATCvet: QC01CE90

Zusammensetzung

Wirkstoff: Pimobendan

1 Kautablette zu 10 mg enthält: Pimobendan 10 mg.

Hilfsstoffe: Aromatica, Excipiens pro compresso.

Fachinformationen Wirkstoffe (CliniPharm)

Pimobendan

Eigenschaften / Wirkungen

Pimobendan, ein Benzimidazol-Pyridazinon Derivat, ist eine nicht-sympathomimetische,

nicht-glycoside inotropische Substanz mit stark vasodilatativen Eigenschaften.

Pimobendan übt seine stimulierende myokardiale Wirkung über zwei Wege aus: Erhöhung

der Calciumsensitivität der kardialen Myofilamente und Hemmung der Phosphodiesterase

(Typ III). Zudem wirkt es auch gefässerweiternd, indem es die Phosphodiesterase III-

Aktivität hemmt.

Pharmakokinetik

Absorption

Nach einer oralen Verabreichung von Pimobendan beträgt die absolute Bioverfügbarkeit

des Wirkstoffes 60 - 63%. Wird Pimobendan mit dem Futter oder kurz danach verabreicht,

sinkt die Bioverfügbarkeit erheblich, es wird darum empfohlen, die Tiere etwa 1 Stunde vor

der Fütterung zu behandeln.

Distribution

Das Verteilungsvolumen beträgt 2,6 l/kg, dies bedeutet, dass Pimobendan rasch in das

Gewebe verteilt wird. Die mittlere Plasmaproteinbindung beträgt 93%.

Metabolismus

Der Wirkstoff wird oxidativ zu seinen wichtigsten aktiven Metaboliten demethylisiert (UD-

CG 212). Weitere Abbauwege sind Phase II-konjugierte Verbindungen von UD-CG 212, im

wesentlichen Glucuronverbindungen und Sulfate.

Elimination

Die Eliminationshalbwertzeit von Pimobendan beträgt 0,4 ± 0,1 Stunden, übereinstimmend

mit einer hohen Clearance von 90 ± 19 ml/Min/kg und einer kurzen mittleren

Aufenthaltszeit von 0,5 ± 0,1 Stunden.

Der wichtigste aktive Metabolit wird mit einer Halbwertzeit im Plasma von

2,0 ± 0,3 Stunden ausgeschieden. Beinahe die ganze Dosis wird via Faeces

ausgeschieden.

Indikationen

Vetmedin Kautabletten sind indiziert zur Behandlung einer Myokardinsuffizienz des

Hundes als Folge einer dilatativen Kardiomyopathie oder Herzklappeninsuffizienz (Mitral-

oder Tricuspidal-Regurgitation).

Vetmedin ist oral in einer Dosierung von 0,2 bis 0,6 mg Pimobendan/kg Körpergewicht und

Tag zu verabreichen. Für die meisten Fälle hat sich eine Dosis von 0,5 mg Pimobendan/kg

Körpergewicht und Tag als ideal erwiesen. Das entspricht 2,5 mg morgens und 2,5 mg

abends pro 10 kg Körpergewicht. Im Falle einer leichtgradigen Myokardinsuffizienz kann

die Behandlung mit der niedrigsten Dosis von 0,2 mg Pimobendan/kg Körpergewicht und

Tag begonnen werden; bei Nichtansprechen innert einer Woche muss die Dosis

entsprechend erhöht werden.

Die Dosis soll auf zwei Gaben (morgens und abends, jeweils ca. eine Stunde vor der

Fütterung) verteilt werden.

Die Vetmedin-Behandlung kann mit Furosemid oder mit anderen Saliuretika kombiniert

werden.

Anwendungseinschränkungen

Kontraindikationen

Vetmedin Kautabletten sollten in Fällen von hypertrophischer Kardiomyopathie oder

klinischen Fällen, wo die Steigerung der Herzleistung aus funktionellen oder anatomischen

Gründen nicht möglich ist (z.B. Aortenstenose), nicht angewendet werden.

Da Vetmedin vorwiegend über die Leber verstoffwechselt wird, sollte es nicht bei Hunden

mit vorliegender schwerer Leberinsuffizienz angewendet werden.

Vorsichtsmassnahmen

Bei Hunden mit bestehendem Diabetes mellitus sollte während der Behandlung eine

regelmässige Blutzuckerkontrolle durchgeführt werden.

In Untersuchungen mit Ratten und Kaninchen hatte Pimobendan keine Auswirkungen auf

die Fruchtbarkeit und eine embryotoxische Wirkung trat erst bei maternotoxischen Dosen

auf. In Rattenversuchen wurde eine Pimobendan Ausscheidung in die Milch

nachgewiesen.

Aus diesen Gründen sollten Vetmedin Kautabletten bei trächtigen oder laktierenden

Hündinnen nur verabreicht werden, wenn der erwartete therapeutische Nutzen die

potentiellen Risiken übertrifft.

Im Falle einer Überdosierung sollte eine symptomatische Behandlung angewendet

werden.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

In seltenen Fällen kann eine leichte positive chronotropische Wirkung und Erbrechen

auftreten. Diese Nebenwirkungen sind dosisabhängig und können durch eine Reduktion

der Dosis vermieden werden. In seltenen Fällen wurde eine vorübergehende Diarrhöe,

Appetitlosigkeit oder Lethargie beobachtet.

Wechselwirkungen

In pharmakologischen Studien wurde keine Interaktion zwischen dem kardialen Glycosid

Ouabain und Pimobendan gefunden. Die durch Pimobendan hervorgerufene Steigerung

der Herzkontraktilität wird in Anwesenheit des Calcium-Antagonisten Verapamil und des ß-

Antagonisten Propranolol wieder vermindert.

Sonstige Hinweise

Haltbarkeit

Das Präparat darf nur bis zu dem auf der Packung mit "EXP" bezeichneten Datum

verwendet werden. Flasche gut verschlossen bei Raumtemperatur (15 - 25°C) lagern.

Aufbrauchfrist nach Anbruch (10 mg Kautabletten): 100 Tage

Tierarzneimittel, für Kinder unerreichbar aufbewahren.

Packungen

Kautabletten zu 10 mg: 50

Abgabekategorie: B

Swissmedic Nr. 57'804

Informationsstand: 04/2014

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FDA - U.S. Food and Drug Administration

19-12-2018

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar:  https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDA pic.twitter.com/sHElqFFODy

FDA - U.S. Food and Drug Administration

19-12-2018

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more:  https

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more: https

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more: https://go.usa.gov/xExHq  pic.twitter.com/fAAZAQx1H5

FDA - U.S. Food and Drug Administration

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

18-12-2018

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers:  https://go.usa.gov/xEx2r  #FDApic.twitter.com/57pZAmSb9r

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDApic.twitter.com/57pZAmSb9r

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDA pic.twitter.com/57pZAmSb9r

FDA - U.S. Food and Drug Administration

18-12-2018

Enalagamma® HCT 10 mg/25 mg Tabletten

Rote - Liste

14-12-2018

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here:  https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/X4IprwU8R2

FDA - U.S. Food and Drug Administration

14-12-2018

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here:  https://go.usa.gov/xE3ke  #FDA #MedicalDevice

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018

OCALIVA® 5 mg / 10 mg Filmtabletten

Rote - Liste