Baxyl Long Acting

Hauptinformation

  • Handelsname:
  • Baxyl Long Acting Injektionslösung 200 mg/ml
  • Dosierung:
  • 200 mg/ml
  • 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:
  • Baxyl Long Acting Injektionslösung 200 mg/ml
    Belgien
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V137146
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Notice – DE version

BAXYL LA

GEBRAUCHSINFORMATION

BAXYL Long Acting

Oxytetracyclinum 20%, Injektionslösung

1.

NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND, WENN UNTERSCHIEDLICH,

DES HERSTELLERS, DER FÜR DIE CHARGENFREIGABE VERANTWORTLICH IST

Prodivet pharmaceuticals sa/nv

Hagbenden, 39c

B-4731 EYNATTEN

Tel : 00 32 (0)87 85 20 25

Fax : 00 32 (0)86 86 68 20

info@prodivet.com

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

BAXYL Long Acting

Oxytetracyclinum 20%, Injektionslösung

3.

WIRKSTOFF(E) UND SONSTIGE BESTANDTEILE

Arzneilich wirksame Bestandteile:

Oxytetracyclin Dihydrat 216 mg (= 200 mg Oxytetracyclin) pro ml.

Sonstige Bestandteile:

Formaldehydesulfoxylat Natrium –Magnesium Oxyd – Dimethylacetamid –Natrium edetat – Ethanolamin –

Wasser für Injektionszwecke bis 1 ml

4.

ANWENDUNGSGEBIET(E)

Behandlung von Infektionen, die durch Oxytetracyclin empfindliche Keime hervorgerufen werden und

die mit einer Ausbreitung von Antibiotika in wirksamer Konzentration im Infektionsherd im Rahmen

der pharmakokinetischen Eigenschaften vereinbar sind.

5.

GEGENANZEIGEN

BAXYL Long Acting nicht bei Katzen, Hunden und Pferden anwenden.

BAXYL LA nicht bei laktierenden Kühen anwenden.

Nieren- oder Leberinsuffizienz.

Überempfindlichkeit gegen Tetracycline.

6.

NEBENWIRKUNGEN

Überempfindlichkeit.

Es kann eine lokale Reaktion an der Injektionsstelle auftreten, die während 21 Tagen anhalten

kann. Ein vorübergehend erhöhter Gehalt von Kreatinkinase kann während 72 Stunden

auftreten (Rinder). Die Reaktionen sind ausgeprägter bei einer Injektion in die Kruppe.

Eine leichte bis mäßige Lahmheit kann während maximal 10 Tagen auftreten.

Die behandelten Tiere, besonders diejenigen mit einer schwachen Hautpigmentierung, können

bei intensiver Sonneneinwirkung eine Photodermatitis entwickeln.

Tetracycline können Kalzium binden und sich im Bereich von Knochen und Zähnen

niedersetzen, was zu einer Verfärbung der Zähne führen kann.

Die Anwendung von Tetracyclinen kann Hypocalcemie und Herz-Kreislaufstörungen

hervorrufen.

Falls Sie Nebenwirkungen insbesondere solche, die nicht in der Packungsbeilage aufgeführt sind, bei Ihrem Tier

feststellen, teilen Sie diese Ihrem Tierarzt mit.

7.

ZIELTIERART(EN)

BAXYL Long Acting wird bei Rindern (Kälbern und Erwachsenen) und Schweinen angewendet.

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Dosierung

Notice – DE version

BAXYL LA

Eine intramuskuläre Injektion von einer Dosis von 20 mg/kg Körpergewicht, entsprechend 1ml/10kg.

Bei schwerwiegenden Infektionen ist eine Wiederholungsbehandlung nach 48 Stunden durchzuführen.

Um eine Unterdosierung zu vermeiden, müsste das Körpergewicht so genau wie möglich festgelegt

werden.

Art der Anwendung

intramuskulären Anwendung.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Die für intramuskuläre Injektionen gebräuchlichen Regeln zur Keimfreiheit anwenden.

Nicht mehr als 10 ml BAXYL LA an der gleichen Stelle injizieren. Die zu verabreichende

Dosis bei Tieren über 100 kg auf mehrere Injektionsstellen verteilen.

BAXYL LA nicht gleichzeitig mit Penicillinen und Cephalosporinen anwenden.

Das Produkt sollte auf Grund der Ergebnisse eines Sensibilisierungstests angewendet werden

wenn eine Resistenz gegen Oxytetracycline vermutet wird.

Es wird empfohlen das Ergebnis der Behandlung 2 Tage nach der letzten Anwendung zu

bewerten. Sollte eine Antibiotherapie noch erforderlich sein, müsste auf ein anderes Antibiotika

zurückgegriffen werden.

10.

WARTEZEIT

Rinder :

Essbare Gewebe : 35 Tage nach Ende der Behandlung.

Nicht bei Tieren anwenden, deren Milch für den menschlichen Verzehr bestimmt ist.

Schweine :

Essbare Gewebe : 14 Tage nach Ende der Behandlung.

11.

BESONDERE LAGERUNGSHINWEISE

Unter 25° C, in der gut verschlossenen Originalverpackung und vor Licht geschützt aufbewahren.

Nicht mehr anwenden nach dem Haltbarkeitsdatum, das auf der Verpackung nach der Abkürzung

Verwendbar bis

(Monat/Jahr) vermerkt ist, d.h. verfallen am letzten Tag des angegebenen Monats.

Haltbarkeitsdauer des Tierarzneimittels nach Anbruch des Behältnisses : 28 Tage.

12.

BESONDERE WARNHINWEISE

Für den Verbraucher :

Dieses Präparat enthält das Antibiotika Oxytetracyclin.

Bei versehentlicher Selbstinjektion ist unverzüglich

ein Arzt zu Rate zu ziehen und die Packungsbeilage oder das Etikett vorzuzeigen.

Personen mit bekannter Überempfindlichkeit gegenüber Oxytetracyclin sollten den Kontakt mit dem

Tierarzneimittel vermeiden

Arzneimittel unzugänglich für Kinder aufbewahren

Für den Arzt :

Keine.

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON NICHT

VERWENDETEM ARZNEIMITTEL ODER VON ABFALLMATERIALIEN

, SOFERN

ERFORDERLICH

Die angemessenen Vorsichtsmaßnahmen müssen getroffen werden, damit das Präparat nicht in die

Umwelt gelangt.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

Notice – DE version

BAXYL LA

Oktober 2012

15.

WEITERE ANGABEN

Verschreibungspflichtig durch den Tierarzt.

Es werden möglicherweise nicht alle Packungsgrößen in Verkehr gebracht

Falls weitere Informationen über das Tierarzneimittel gewünscht werden, setzen Sie sich bitte

in Verbindung

mit:

Prodivet pharmaceuticals sa/nv

Hagbenden, 39c

B-4731 EYNATTEN

Tel : 00 32 (0)87 85 20 25

Fax : 00 32 (0)87 86 68 20

info@prodivet.com

BAXYL_NOT_DE_V1_20120926

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