Baytril MAX 100 mg ml ad us. vet.

Hauptinformation

  • Handelsname:
  • Baytril MAX 100 mg/ml ad us. vet., Injektionslösung
  • Darreichungsform:
  • Injektionslösung
  • Verwenden für:
  • Tiere
  • Art der Medizin:
  • allopathic Droge

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  • 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.


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Lokalisierung

  • Erhältlich in:
  • Baytril MAX 100 mg/ml ad us. vet., Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Antibiotikum (Gyrasehemmer) zur Behandlung von Rindern und Schweinen.

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 65483
  • Letzte Änderung:
  • 02-09-2017

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

Baytril MAX 100 mg/ml ad us. vet., Injektionslösung

Provet AG

Antibiotikum (Gyrasehemmer) zur Behandlung von Rindern und Schweinen.

ATCvet: QJ01MA90

Zusammensetzung

1 ml Injektionslösung enthält:

Wirkstoff

Enrofloxacin 100 mg.

Hilfsstoffe

L-Arginin 200 mg, n-Butanol 30 mg, Conservans: Benzylalkohol (E1519) 20 mg, Wasser

für Injektionszwecke qs ad 1 ml.

Galenische Form

Injektionslösung.

Klare, gelbe Lösung.

Fachinformationen Wirkstoffe (CliniPharm)

Enrofloxacin

Eigenschaften / Wirkungen

Enrofloxacin besitzt ein Wirkungsspektrum, welches beim Rind Histophilus somni,

Mannheimia haemolytica, Pasteurella multocida, Mycoplasma spp. und E.coli sowie beim

Schwein Actinobacillus pleuropneumoniae, Pasteurella multocida und Haemophilus

parasuis einschliesst.

Enrofloxacin gehört zur Klasse der Fluorchinolone. Die Substanz besitzt eine bakterizide

Wirkung, die über eine Bindung an die A-Untereinheit der bakteriellen DNA-Gyrase und

die dadurch verursachte selektive Hemmung dieses Enzyms vermittelt wird.

Die DNA-Gyrase gehört zu den Topoisomerasen, die bei Bakterien an der Replikation,

Transkription und Rekombination der DNA beteiligt sind. Fluorchinolone beeinflussen auch

Bakterien in der Ruhephase aufgrund von Änderungen der Zellwandpermeabilität.

MHK-Daten

Die in der Tabelle unten referenzierten Isolate stammen von erkrankten Schweinen und

Rindern aus verschiedenen EU Ländern zwischen 1998 und 2014.

Rind

Spezies

Anzahl Stämme

MHK

50

(µg/ml)

MHK

90

(µg/ml)

Resistenz (%)

Mannheimia haemolytica 648

0,03 - 0,06

0,06 - 0,5

Pasteurella multocida

0,008 -

0,03

0,03 -

0,15

Histophilus somni

0,03

0,06

E. coli (Mastitis)

1297

0,015 -

0,03

0,03 -

0,06

0 - 4,0

Mycoplasma bovis

0,12 - 0,5

0,5 - 8

0 - 11,1

Schwein:

Spezies

Anzahl

Stämme

MHK

50

(µg/ml)

MHK

90

(µg/ml)

Resistenz

(%)

Actinobacillus pleuropneumoniae 741

0,015 - 0,06

0,03 - 0,12

Pasteurella multocida

1125

0,008 - 0,015

0,015 -

0,03

Haemophilus parasuis

0,008 - 0,015 0,03 - 0,06

Enrofloxacin Referenz Breakpoints liegen von Mannheimia haemolytica, Pasteurella

multocida and Histophilus somni isoliert aus Rindern (≥ 2 µg/ml, CLSI Dokument M31-A3)

und für Pasteurella multocida und Actinobacillus pleuropneumoniae isoliert aus Schweinen

(≥ 1 µg/ml, CLSI Dokument M31-A4) vor.

Fluorchinolon-Resistenzen lassen sich in fünf grundlegende Typen einteilen,

Punktmutationen innerhalb der Gene, die die DNA-Gyrase und/oder die Topoisomerase

IV kodieren und so zu Veränderungen des jeweiligen Enzyms führen,

(ii) Veränderungen in der Wirkstoffpermeabilität bei gram-negativen Bakterien,

(iii

Effluxmechanismen,

Plasmid vermittelte Resistenz und

(v) Gyrase-Schutzproteine

Alle Mechanismen führen zu einer reduzierten Empfindlichkeit der Bakterien gegenüber

Fluorchinolonen. Kreuzresistenzen innerhalb der Klasse der Fluorchinolone sind häufig.

Bei Enrofloxacin liegen die inhibitorischen und die bakteriziden Konzentrationen dicht

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

2 Verdünnungsstufen.

Pharmakokinetik

Nach Applikation des Tierarzneimittels wird der Wirkstoff Enrofloxacin sehr schnell und

nahezu vollständig aufgenommen (hohe Bioverfügbarkeit).

Ungefähr 50% der Muttersubstanz Enrofloxacins wird zum aktiven Metaboliten

Ciprofloxacin umgesetzt.

Enrofloxacin besitzt ein grosses Verteilungsvolumen. Die Konzentrationen in den

Geweben und Organen übertreffen die Serumspiegel zumeist deutlich. Organe, in denen

hohe Konzentrationen erwartet werden können, sind Lunge, Leber, Nieren, Darm sowie

Muskelgewebe.

Die Elimination erfolgt über die Niere und bei laktierenden Tieren auch über die Milch.

Tabelle zu pharmakokinetischen Werten bei Rind und Schwein:

Zieltier

Rind

Enrofloxacin

Dosis/kg KGW

7,5 mg

5 mg

Applikationsart

s.c.

i.v.

Nachweis in

Plasma

Plasma

Enrofloxacin

("Parent")

0,71 mg/L 23 mg/L

5,1 h

unmittelbar

4,9 h

0,9 h

0-24h

7,7 mg*h/

4,4 mg*h/L

Ciprofloxacin

("Metabolit")

0,3 mg/L

1,2 mg/L

6,0 h

0,2 h

6,4 h

2,1 h

0-24h

4,1 mg*h/

2,3 mg*h/L

Zieltier

Rind

Schwein

Enrofloxacin

Dosis/kg KGW

5 mg

7.5 mg

Applikationsart

i.v.

i.m.

Nachweis in

Milch

Plasma

Enrofloxacin

("Parent")

1,2 mg/L

1,46 mg/L

0,5 h

4,0 h

0,9 h

13,1 h

0-24h

2,2 mg*/h 20,9 mg*h/L

Ciprofloxacin

("Metabolit")

4,0 mg/L

k.A.*

k.A.*

2,4 h

k.A.*

0-24h

21 mg*h/L k.A.*

*k.A.: keine Angabe möglich (im Schwein sind nur vernachlässigbare Ciprofloxacin

Konzentrationen im Plasma messbar)

Indikationen

Rind:

Zur Behandlung von Erkrankungen des Respirationstraktes, hervorgerufen durch

Enrofloxacin-empfindliche Histophilus somni, Mannheimia haemolytica, Pasteurella

multocida und Mycoplasma spp. Zur Behandlung von Mastitiden verursacht durch

Ciprofloxacin-empfindliche E.coli.

Schwein:

Zur Behandlung von bakteriellen Bronchopneumonien bei Schweinen, hervorgerufen

durch Enrofloxacin-empfindliche Actinobacillus pleuropneumoniae, Pasteurella multocida

und bei Haemophilus parasuis als sekundären Erreger.

Die Wirksamkeit zur Behandlung der Glässerschen Krankheit wurde nicht nachgewiesen.

Rind:

Die Dosierung bei Atemwegsinfektionen beträgt 7,5 mg Enrofloxacin pro kg

Körpergewicht (KGW) bei einmaliger subkutaner (s.c.) Anwendung.

Das entspricht:

7,5 ml Baytril MAX Injektionslösung pro 100 kg KGW

Pro Injektionsstelle dürfen nicht mehr als 15 ml (Rind) oder 7,5 ml (Kalb) s.c. verabreicht

werden. Bei schweren oder chronischen Atemwegsinfektionen kann 48 Stunden später

eine zweite Injektion erforderlich sein.

Die Dosierung zur Behandlung der Colimastitis beträgt 5 mg Enrofloxacin pro kg KGW

bei intravenöser (i.v.) Applikation.

Das entspricht:

5 ml Baytril MAX Injektionslösung pro 100 kg KGW und Tag.

Die Behandlung einer Colimastitis sollte ausschliesslich durch i.v. Injektion an 2 bis

3 aufeinanderfolgenden Tagen erfolgen.

Schwein:

Die Dosierung bei Atemwegsinfektionen beträgt 7,5 mg Enrofloxacin pro kg

Körpergewicht (KGW) bei einmaliger Verabreichung.

Das entspricht:

0,75 ml Baytril MAX Injektionslösung pro 10 kg KGW

Um eine korrekte Dosierung zu gewährleisten und Unterdosierungen zu vermeiden, sollte

das Körpergewicht so genau wie möglich ermittelt werden.

Applikationsart

Rind:

Zur einmaligen subkutanen Injektion (respiratorische Erkrankungen) bzw. zur mehrmaligen

intravenösen Injektion (E.coli-Mastitis).

Schwein:

Zur einmaligen intramuskulären Injektion in die Nackenmuskulatur hinter dem Ohr.

Überdosierung

Beim Rind wurde eine Dosis von 25 mg/kg Körpergewicht bei subkutaner Applikation über

einen Zeitraum von 15 aufeinanderfolgenden Tagen symptomlos vertragen. Höhere

Dosierungen im Rind und eine Dosis von etwa 25 mg Wirkstoff pro kg Körpergewicht und

mehr beim Schwein können Lethargie, Lahmheit, Ataxie, geringgradiges Speicheln und

Muskelzittern verursachen.

Die empfohlene Dosis darf nicht überschritten werden. Bei versehentlicher Überdosierung

muss symptomatisch behandelt werden, da kein Antidot zur Verfügung steht.

Anwendungseinschränkungen

Kontraindikationen

Nicht anwenden bei bekannter Überempfindlichkeit gegenüber dem Wirkstoff oder einem

der sonstigen Bestandteile. Nicht anwenden bei Tieren mit zentralen Anfallsleiden. Nicht

anwenden bei bereits bestehenden Knorpelwachstumsstörungen oder Schädigungen des

Bewegungsapparates im Bereich funktionell besonders beanspruchter oder durch das

Körpergewicht besonders belasteter Gelenke. Nicht zur Prophylaxe anwenden.

Nicht anwenden bei vorliegender Resistenz gegenüber Chinolonen, da gegenüber diesen

eine nahezu vollständige, gegenüber anderen Fluorochinolonen eine komplette

Kreuzresistenz besteht.

Vorsichtsmassnahmen

Fluorchinolone sollten der Behandlung klinischer Erkrankungen vorbehalten

bleiben, die auf andere Klassen von Antibiotika unzureichend angesprochen haben

bzw. bei denen mit einem unzureichenden Ansprechen zu rechnen ist. Baytril MAX

100 mg/ml ad us. vet. soll nur nach bakteriologischer Sicherung der Diagnose und

Sensitivitätsprüfung der beteiligten Erreger sowie bei Vorliegen von Resistenzen

gegenüber anderen Antibiotika angewandt werden.

Der Einsatz von Baytril MAX 100 mg/ml ad us. vet., wie der aller Fluorochinolone,

soll aus Gründen einer möglichen Resistenzentwicklung nicht bei geringfügigen

Infektionen erfolgen.

Wiederholte subkutane (Kalb, Rind) oder intramuskuläre (Schwein) Injektionen oder

Injektionsvolumina von mehr als 15 ml (Rinder) oder 7,5 ml (Schweine, Kälber) sollten an

verschiedenen KörpersteIlen appliziert werden.

Bei der Anwendung des Arzneimittels sind die offiziellen Richtlinien für Antibiotika zu

beachten.

Eine von den Vorgaben in der Fachinformation abweichende Anwendung des

Tierarzneimittels kann die Prävalenz von Bakterien, die gegen Fluorchinolone resistent

sind, erhöhen und die Wirksamkeit von Behandlungen mit anderen Chinolonen infolge

möglicher Kreuzresistenzen vermindern.

Die Elimination von Enrofloxacin erfolgt über die Niere, bei bestehenden Nierenschäden

ist daher, wie bei allen Fluorchinolonen, mit einer Verzögerung der Ausscheidung zu

rechnen.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

In seltenen Fällen kann es zu vorübergehenden lokalen Gewebereaktionen

(Schwellungen, Rötungen) an der Injektionsstelle kommen. Diese klingen innerhalb

weniger Tage ohne weitere ärztliche Massnahmen ab.

In seltenen Fällen kann die intravenöse Behandlung bei Rindern, vermutlich als Folge von

Kreislaufstörungen, zum Auftreten von Schockreaktionen führen.

Vereinzelt ist bei der Behandlung von Kälbern mit dem Auftreten gastrointestinaler

Störungen zu rechnen.

Rind:

Essbare Gewebe:s.c.:14 Tage

i.v.: 7 Tage

Milch:

s.c.:5 Tage

i.v. :3 Tage

Schwein:

Essbare Gewebe:i.m.:12 Tage

Wechselwirkungen

Bei gleichzeitiger Anwendung von Makrolidantibiotika und Tetrazyklinen können

antagonistische Effekte auftreten. Enrofloxacin kann den Metabolismus von Theophyllin

beeinflussen, so dass die Theophyllin-Clearance erniedrigt wird und höhere Theophyllin-

Plasmaspiegel resultieren.

Sonstige Hinweise

Inkompatibilitäten

Da keine Kompatibilitätsstudien durchgeführt wurden, darf dieses Tierarzneimittel nicht mit

anderen Tierarzneimitteln gemischt werden.

Besondere Vorsichtsmassnahmen für den Anwender

Personen mit bekannter Überempfindlichkeit gegen Chinolonen sollten den Kontakt mit

dem Tierarzneimittel vermeiden.

Den direkten Kontakt mit der Haut vermeiden, da eine Sensibilisierung, Kontaktdermatitis

sowie eine Überempfindlichkeitsreaktion auftreten könnte.

Bei Augen- oder Hautkontakt sofort mit Wasser spülen. Während der Anwendung nicht

essen, trinken oder rauchen.

Sorgfalt ist geboten, um eine Selbstinjektion zu vermeiden. Bei versehentlicher

Selbstinjektion ist unverzüglich ein Arzt zu konsultieren und diesem die Packungsbeilage

vorzulegen.

Lagerungshinweise

Arzneimittel unzugänglich für Kinder aufbewahren.

Bei 15 - 30°C lagern. Nicht einfrieren.

Haltbarkeit nach dem ersten Öffnen des Behältnisses: 28 Tage.

Das Datum der ersten Entnahme ist auf dem Etikett der Durchstechflasche einzutragen.

Das Tierarzneimittel darf nur bis zu dem auf der Verpackung mit «EXP» oder «Verw. bis»

bezeichneten Datum verwendet werden.

Hinweise für die Handhabung

Der Verschlussstopfen kann bis zu 20-mal unbedenklich durchstochen werden.

Abgelaufene Tierarzneimittel bitte dem Tierarzt oder der Apotheke zur umweltgerechten

Entsorgung zurückzubringen. Arzneimittel gehören nicht in den Haushaltabfall.

Packungen

1 Flasche zu 100 ml

Abgabekategorie: A

Swissmedic Nr. 65'483

Informationsstand: 10/2015

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Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys f...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Peer review of the pesticide risk assessment of the active substance propanil

Peer review of the pesticide risk assessment of the active substance propanil

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Ampi-Kur ad us. vet., Eutersuspension

Ampi-Kur ad us. vet., Eutersuspension

● Die Zulassung ist am 21.12.2018 erloschen.

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Versican Plus DHPPi/L4 ad us. vet.

Versican Plus DHPPi/L4 ad us. vet.

● Änderung Text "Kurzbezeichnung", "Zusammensetzung", "Indikation", "Dosierung / Anwendung", "Anwendungseinschränkungen", "Unerwünschte Wirkungen", "Wechselwirkungen", "Sonstige Hinweise" und "Packungen"

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Versican Plus DHPPi/L4R ad us. vet.

Versican Plus DHPPi/L4R ad us. vet.

● Änderung Text "Zusammensetzung", "Indikation", "Dosierung / Anwendung", "Anwendungseinschränkungen", "Unerwünschte Wirkungen", "Wechselwirkungen", "Sonstige Hinweise" und "Packungen"

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Versican Plus L4 ad us. vet.

Versican Plus L4 ad us. vet.

● Änderung Text "Eigenschaften", "Dosierung / Anwendung", "Anwendungseinschränkungen", "Unerwünschte Wirkungen", "Wechselwirkungen" und "Sonstige Hinweise"

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Versican Plus Pi/L4 ad us. vet.

Versican Plus Pi/L4 ad us. vet.

● Änderung Text "Kurzbezeichnung", "Zusammensetzung", "Indikationen", "Dosierung / Anwendung", "Anwendungseinschränkungen", "Unerwünschte Wirkungen" und "Wechselwirkungen"

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Perlutex ad us. vet., Tabletten

Perlutex ad us. vet., Tabletten

● Änderung Text "Zusammensetzung", "Dosierung / Anwendung" und "Sonstige Hinweise"

Institut für Veterinärpharmakologie und toxikologie

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Schauma-Dip ad us. vet., Zitzendesinfektionsmittel

Schauma-Dip ad us. vet., Zitzendesinfektionsmittel

● Neue Zulassungsinhaberin: Halag Chemie AG

Institut für Veterinärpharmakologie und toxikologie

14-12-2018

Bovilis BTV8 ad us. vet.

Bovilis BTV8 ad us. vet.

● Die Zulassung ist am 14.12.2018 erloschen.

Institut für Veterinärpharmakologie und toxikologie

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

17-1-2019

Aldurazyme® 100 E/ml

Rote - Liste

17-1-2019

Zyvoxid® 100 mg/5 ml

Rote - Liste

17-1-2019

Retrovir 100 mg Hartkapseln

Rote - Liste

15-1-2019

Pifeltro 100 mg Filmtabletten

Rote - Liste

7-1-2019

Biofanal® 100 000 I.E. Kombipackung

Rote - Liste

4-1-2019

Thybon® 20/100 Henning

Rote - Liste

20-12-2018

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here:  https://go.usa.gov/

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/

. @US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB  #MedicalDevice

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

ISOZID® comp. 100/200/300 mg N

Rote - Liste

19-12-2018

Ciprobay® 100 mg

Rote - Liste

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

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