Inflacam 15 mg ml ad us. vet.

Hauptinformation

  • Handelsname:
  • Inflacam® 15 mg/ml ad us. vet., orale Suspension
  • Darreichungsform:
  • orale Suspension
  • 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:
  • Inflacam® 15 mg/ml ad us. vet., orale Suspension
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Nichtsteroidales Antiphlogistikum für Pferde

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 62534
  • Letzte Änderung:
  • 02-09-2017

Packungsbeilage

Inflacam

15 mg/ml ad us. vet., orale Suspension

Virbac (Switzerland) AG

Nichtsteroidales Antiphlogistikum für Pferde

ATCvet: QM01AC06

Zusammensetzung

1 ml Suspension enthält:

Wirkstoff: Meloxicamum 15 mg

Hilfsstoffe: Conserv.: Natrii benzoas E 211; Aromatica: Saccharinum natricum et alia.

Excip. ad suspensionem.

Fachinformationen Wirkstoffe (CliniPharm)

Meloxicam

Eigenschaften / Wirkungen

Inflacam enthält den Wirkstoff Meloxicam, ein nicht-steroidales Antiphlogistikum der

Oxicam-Gruppe und wirkt durch Hemmung der Prostaglandin-Synthese. Meloxicam wirkt

antiinflammatorisch, antiexsudativ, analgetisch und antipyretisch. Es hemmt die

Leukozyten-Infiltration ins entzündete Gewebe. Ausserdem besteht eine schwache

Hemmung der kollagen-induzierten Thrombozyten-Aggregation. Meloxicam hemmt auch

die Endotoxinwirkung.

Pharmakokinetik

Absorption

Bei Einnahme nach dem empfohlenen Dosierungsschema wird eine orale Bioverfügbarkeit

von ungefähr 98% erreicht. Maximale Plasmakonzentrationen werden nach circa 2 -

3 Stunden erreicht. Der Akkumulationsfaktor von 1,08 weist darauf hin, dass Meloxicam

bei einer täglichen Gabe nicht akkumuliert wird.

Distribution

Meloxicam ist zu ungefähr 98% an Plasmaproteine gebunden. Das Verteilungsvolumen

beträgt 0,12 l/kg.

Metabolismus

Der Metabolismus ist bei Ratten, Minipigs, Menschen, Rindern und Schweinen qualitativ

ähnlich; es bestehen jedoch quantitative Unterschiede. Die Hauptmetaboliten, welche in

diesen Spezies gefunden wurden, sind 5-Hydroxy- und 5-Carboxy-Metaboliten und der

Oxalyl-Metabolit. Alle Hauptmetaboliten erwiesen sich als pharmakologisch inaktiv. Der

Metabolismus bei Pferden wurde nicht untersucht.

Elimination

Meloxicam wird mit einer terminalen Halbwertszeit von 7,7 Stunden eliminiert.

Indikationen

Linderung von Entzündungen und Schmerzen bei akuten und chronischen Erkrankungen

des Bewegungsapparates.

Dosierung

lnflacam 15 mg/ml wird einmal täglich in einer Dosis von 1 ml/25 kg Körpergewicht (d.h.

0,6 mg Meloxicam pro kg KGW) mit dem Futter oder direkt in das Maul verabreicht.

Maximale Therapiedauer: 14 Tage.

Allgemeine Hinweise

Die Suspension vor der Anwendung gut schütteln.

Die Suspension sollte mit Hilfe der jeder Packung beiliegenden Dosierspritze verabreicht

werden. Die Spritze passt auf den Behälter der Suspension und weist eine Graduierung in

kg Körpergewicht auf. Kontaminationen von Dosierspritze und verbleibendem

Flascheninhalt während der Anwendung sind zu vermeiden.

Anwendungseinschränkungen

Kontraindikationen

Inflacam 15 mg/ml soll nicht angewendet werden bei:

-bekannter Überempfindlichkeit gegenüber Meloxicam oder einem der Hilfsstoffe;

-säugenden oder trächtigen Stuten;

Tieren mit gastrointestinalen Störungen, speziell bei Blutungen, verminderter Leber-,

Herz- oder Nieren-Funktion und mit hämorrhagischen Erkrankungen;

gleichzeitiger Behandlung mit Glukokortikoiden, anderen nicht-steroidalen Antiphlogistika

oder Antikoagulantien;

-Tieren mit nachgewiesenen Blutgerinnungsstörungen sowie

-bei Fohlen, die jünger als 6 Wochen sind.

Vorsichtsmassnahmen

Beim Auftreten von unerwünschten Wirkungen, sollte die Behandlung abgebrochen und

ein Tierarzt aufgesucht werden.

Der Gebrauch bei dehydrierten, hypovolämischen oder hypotensiven Tieren sollte

vermieden werden, da ein potenzielles Risiko von renaler Toxizität besteht.

Anwendung während der Trächtigkeit oder Laktation:

Laborstudien bei Rindern haben keine Anzeichen von Teratogenizität, Fötotoxizität oder

maternotoxischen Effekten gezeigt. Jedoch existieren keine Daten bei Pferden. Deshalb

wird der Gebrauch bei Stuten während der Trächtigkeit oder der Säugezeit/Laktation nicht

empfohlen.

Überdosierung

Bei Überdosierung soll eine symptomatische Behandlung gestartet werden.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

Vereinzelte Fälle von typischen Nebenwirkungen der nicht-steroidalen Antiphlogistika

wurden in klinischen Studien beobachtet (leichte Urtikaria, Durchfall). Die Symptome

waren nach Absetzen der Therapie reversibel. In sehr seltenen Fällen wurden

Appetitlosigkeit, Lethargie, Bauchschmerzen und Kolitis berichtet. In sehr seltenen Fällen

können anaphylaktoide Reaktionen auftreten, die schwerwiegend (auch tödlich) sein

können, die symptomatisch behandelt werden sollten. Falls Nebenwirkungen auftreten,

sollte die Behandlung abgebrochen und der Rat des Tierarztes eingeholt werden.

Essbares Gewebe: 3 Tage

Wechselwirkungen

-Andere nicht-steroidale Antiphlogistika, Diuretika, Antikoagulantien, Aminoglykosid-

Antibiotika und Substanzen mit einer hohen Plasma-Protein-Bindung können um die

Protein-Bindung konkurrieren und somit zu toxischen Effekten führen. Inflacam 15 mg/ml

sollte nicht zusammen mit anderen nicht-steroidalen Antiphlogistika oder

Glukokortikoiden verabreicht werden (vgl. Kontraindikationen).

Eine Vorbehandlung mit entzündungshemmenden Mitteln kann als Folge zusätzliche oder

verstärkte Nebenwirkungen hervorrufen. Daher sollte vor dem Einsatz von Inflacam

15 mg/ml die Behandlung mit solchen Mitteln für mindestens 24 Stunden ausgesetzt

werden.

Bei der Festsetzung der Dauer der behandlungsfreien Periode sind jedoch die

pharmakokinetischen Eigenschaften des vorher verwendeten Produktes zu

berücksichtigen.

Sonstige Hinweise

Besondere Vorsichtsmassnahmen für den Anwender:

Personen, die überempfindlich auf nicht-steroidale Antiphlogistika reagieren, sollten den

direkten Kontakt mit dem Präparat vermeiden.

-Bei einer versehentlichen Einnahme sollte unverzüglich ein Arzt aufgesucht werden.

Haltbarkeit:

Bei Raumtemperatur (15 - 25°C) lagern. Aufbrauchsfrist nach erster Entnahme: 3 Monate.

Das Präparat darf nur bis zu dem auf dem Behälter mit 'EXP' bezeichneten Datum

verwendet werden.

Arzneimittel für Kinder unerreichbar aufbewahren.

Packungen

Flaschen zu 100 und 250 ml mit Dosierspritze

Abgabekategorie: B

Swissmedic Nr. 62'534

Informationsstand: 12/2016

Dieser Text ist behördlich genehmigt.

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Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

17-10-2018

Save the date & Join the @US_FDA’s  Patient Engagement Advisory Committee on Nov 15th to discuss  patient-generated health data from sources like social media, activity  trackers, and patient-driven registries. Learn more:  https://go.usa.gov/xPRau  #Digi

Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #Digi

Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #DigitalHealth #PEAC2018 pic.twitter.com/NU61Snpxxw

FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

10-10-2018

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIH pic.twitter.com/AwYhetCBiw

FDA - U.S. Food and Drug Administration

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety