Butagran Equi

Hauptinformation

  • Handelsname:
  • Butagran Equi Pulver zum Einnehmen 200 mg/g
  • Dosierung:
  • 200 mg/g
  • Darreichungsform:
  • Pulver zum Einnehmen
  • 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:
  • Butagran Equi Pulver zum Einnehmen 200 mg/g
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Anti-entzündliche und antirheumatische Produkte, nicht - Steroide

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V437035
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Bijsluiter – DE Versie

BUTAGRAN EQUI

PACKUNGSBEILAGE

GEBRAUCHSINFORMATION FÜR

Butagran Equi, 200 mg/g, Pulver zum Eingeben für Pferde

1.

NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND, WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE CHARGENFREIGABE

VERANTWORTLICH IST

Zulassungsinhaber:

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer - Niederlande

Für die Chargenfreigabe verantwortlicher Hersteller:

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer - Niederlande

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

Butagran Equi, 200 mg/g, Pulver zum Eingeben für Pferde.

Phenylbutazon

3.

WIRKSTOFF(E) UND SONSTIGE BESTANDTEILE

Pro g:

Wirkstoff:

Phenylbutazon

200 mg

4.

ANWENDUNGSGEBIET(E)

Zur Behandlung von Erkrankungen des Bewegungsapparates, bei denen eine Schmerzlinderung und

eine Reduzierung der begleitenden Entzündung erforderlich ist, z. B. bei Lahmheit in

Zusammenhang mit Osteoarthrosen, Bursitis, Laminitis und Weichteilgewebeentzündungen,

insbesondere wenn eine Beibehaltung der Mobilität als wünschenswert erachtet wird.

Es kann auch zur Begrenzung einer postoperativen Entzündung, einer Myositis und anderer

Weichteilgewebeentzündungen eingesetzt werden.

Das Präparat kann gegebenenfalls als Antipyretikum angewendet werden, z. B. bei viralen

Atemwegserkrankungen.

5.

GEGENANZEIGEN

Nicht anwenden im Falle einer Überempfindlichkeit der Tiere gegenüber dem arzneilich wirkenden

Bestandteil.

Nicht bei Tieren mit Erkrankung des Herzens, der Leber oder der Nieren anwenden, wenn die

Möglichkeit einer Ulzeration oder Blutung im Magendarmtrakt besteht oder Blutbildstörungen

vorliegen.

Bijsluiter – DE Versie

BUTAGRAN EQUI

6.

NEBENWIRKUNGEN

Wie bei anderen nichtsteroidalen Antiphlogistika (NSAID), die die Prostaglandinsynthese hemmen,

kann eine gastrische und/oder renale Unverträglichkeit auftreten. Dies steht meist in

Zusammenhang mit einer Überdosierung und tritt daher selten auf. Die Symptome bilden sich

normalerweise nach Abbruch der Behandlung und nach Einleitung einer unterstützenden

symptomatischen Therapie zurück (für weitere Informationen siehe Besondere Warnhinweise -

Überdosierung).

Ponys sind bei diesem Präparat selbst bei therapeutischen Dosen sehr empfindlich für Ulzerationen

im Magen (Durchfall, Ulzerationen im Maul und Hypoproteinämie können ebenfalls auftreten).

Falls Sie Nebenwirkungen, insbesondere solche, die nicht in dieser Packungsbeilage aufgeführt

sind, bei Ihrem Tier feststellen, teilen Sie diese Ihrem Tierarzt oder Apotheker mit.

7.

ZIELTIERART(EN)

Pferd

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Zum Eingeben.

Pro 450 kg Körpergewicht sollte, je nach individuellem Ansprechen, folgende Dosierung gewählt

werden:

Tag 1: Zwei Beutel bzw. 10 g von dem Präparat zweimal täglich (entspricht 4,4 mg

Phenylbutazon/kg Körpergewicht pro Anwendung).

Tag 2-4: Ein Beutel bzw. 5 g von dem Präparat zweimal täglich (entspricht 2,2 mg

Phenylbutazon/kg Körpergewicht pro Anwendung), gefolgt von einem Beutel bzw. 5 g täglich (2,2

mg Phenylbutazon/kg Körpergewicht pro Tag) oder, je nach Bedarf, jeden zweiten Tag.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Wenn nach 4-5 Tagen keine Besserung erkennbar ist, ist die Behandlung abzubrechen. Heu kann die

Resorption von Phenylbutazon und damit auch den Zeitpunkt des Einsetzens einer klinischen

Wirkung verzögern. Es ist ratsam, unmittelbar vor oder während der Anwendung des Präparats kein

Heu anzubieten.

Zur leichteren Anwendung kann das Präparat mit einer eingeschränkten Menge an Kleie oder Hafer

gemischt werden.

10.

WARTEZEIT

Nicht zur Anwendung bei Pferden, die für den Verzehr durch den Menschen bestimmt sind.

Behandelte Pferde dürfen nicht für den Verzehr durch den Menschen geschlachtet werden.

Das Pferd muss im Rahmen der nationalen Pferdepass-Vorschriften als nicht für den Verzehr durch

den Menschen deklariert werden.

Bijsluiter – DE Versie

BUTAGRAN EQUI

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel unzugänglich für Kinder aufbewahren.

Nicht über 25°C lagern.

Die Beutel im Umkarton aufbewahren. Sie dürfen das Tierarzneimittel nach dem auf dem Beutel

unter EXP angegebenen Verfalldatum nicht mehr anwenden.

Haltbarkeit nach dem ersten Öffnen des Beutels: Sofort nach dem Öffnen anwenden.

12.

BESONDERE WARNHINWEISE

Besondere Warnhinweise für jede Zieltierart

Die klinischen Wirkungen von Phenylbutazon können nach Absetzen der Therapie mindestens drei

Tage lang anhalten. Dies ist zu berücksichtigen, wenn die Pferde einer gesundheitlichen

Untersuchung unterzogen werden.

Die FEI betrachtet Phenylbutazon als verbotenen Wirkstoff, es sollte daher mindestens 8 Tage vor

einem Wettkampf nicht angewendet werden.

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren

Die angegebene Dosis nicht überschreiten, da der therapeutische Index von Phenylbutazon niedrig

ist.

Die Anwendung bei unter 6 Wochen alten Tieren oder bei älteren Tieren kann zusätzliche Risiken

bergen. Wenn sich eine solche Anwendung nicht vermeiden lässt, ist unter Umständen eine

sorgfältige klinische Überwachung der Tiere angezeigt.

Die Anwendung bei dehydrierten, hypovolämischen oder hypotonischen Tieren vermeiden, da das

Risiko einer erhöhten Nierentoxizität besteht. Während der Dauer der Behandlung stets für

ausreichend Trinkwasser sorgen, um eine Dehydrierung zu vermeiden.

NSAIDs können eine Hemmung der Phagozytose bewirken. Deshalb sollte bei der Behandlung von

Enzündungen in Verbindung mit bakteriellen Infektionen begleitend eine geeignete antibakterielle

Therapie eingeleitet werden.

Besondere Vorsichtsmaßnahmen für den Anwender

Nach der Anwendung die Hände waschen.

Berührung mit den Augen vermeiden. Versehentlich in die Augen gelangtes Präparat mit reichlich

Wasser ab- bzw. auswaschen. Bei anhaltender Reizung einen Arzt hinzuziehen.

Es ist darauf zu achten, ein Einatmen oder Verschlucken des Pulvers zu vermeiden.

Bei versehentlichem Einatmen oder Verschlucken ist unverzüglich ein Arzt zu Rate zu ziehen und

die Produktverpackung vorzuzeigen.

Anwendung während der Trächtigkeit oder Laktation

Trächtigkeit:

Bei der Anwendung bei trächtigen Stuten ist Vorsicht geboten. Wenngleich aus der praktischen

Anwendung keine unerwünschten Auswirkungen von Phenylbutazon auf den Fötus oder die

Erhaltung der Trächtigkeit bekannt sind, sind keine definitiven Verträglichkeitsstudien bei Stuten

durchgeführt worden.

Bei Versuchstierarten sind bei hohen Dosen von Phenylbutazon fötotoxische Wirkungen

aufgetreten.

Laktation:

Die Verträglichkeit des Präparats bei laktierenden Stuten wurde nicht gezeigt. Wenn die Anwendung

von Phenylbutazon bei trächtigen oder laktierenden Stuten als unabdinglich erachtet wird, sind die

möglichen Vorteile gegenüber dem möglichen Risiko für die Stute und/oder das Fohlen abzuwägen.

Bijsluiter – DE Versie

BUTAGRAN EQUI

Eine Anwendung um den Zeitraum der Geburt ist zu vermeiden.

Wechselwirkungen mit anderen Arzneimitteln und andere Wechselwirkungen

Die gleichzeitige Verabreichung potenziell nierentoxischer Arzneimittel ist zu vermeiden.

Phenylbutazon ist zu einem großen Teil an Plasmaproteine gebunden. Es kann andere Wirkstoffe,

die ebenfalls stark proteingebunden sind, verdrängen, z. B. einige Sulfonamide oder Warfarin, oder

kann selbst verdrängt werden, was zu einem Anstieg von ungebundenen pharmakologisch

wirkzamen Konzentrationen und zu toxischen Wirkungen führen kann.

Bei der gleichzeitigen Anwendung anderer Therapeutika ist aufgrund des Risikos metabolischer

Wechselwirkungen Vorsicht geboten. Phenylbutazon kann mit dem Metabolismus anderer

Wirkstoffe wie etwa von Warfarin und Barbituraten konkurrieren, sodass es zum Auftreten von

Toxizität kommen kann.

Es gibt Hinweise darauf, dass die Pharmakokinetik von Penicillin- und Gentamicinpräparaten bei

gleichzeitiger Verabreichung von Phenylbutazon enthaltenden Präparaten beeinflusst und die

therapeutische Wirksamkeit aufgrund einer verminderten Verteilung in das Gewebe abgeschwächt

werden kann. Auch die Verteilung anderer, gleichzeitig angewendeter Arzneimittel kann betroffen

sein.

Andere NSAIDS nicht begleitend oder innerhalb von 24 Stunden nacheinander anwenden.

Phenylbutazon regt die Aktivität hepatischer mikrosomaler Enzyme an.

Überdosierung (Symptome, Notfallmaßnahmen, Gegenmittel), falls erforderlich

Eine Überdosierung kann zu Ulzerationen im Magen und im Dickdarm und zu einer allgemeinen

Enteropathie führen. Es kann außerdem zu einer Schädigung der Nierenpapillen und in der Folge zu

einer Beeinträchtigung der Nierenfunktion kommen. Aufgrund eines Verlustes von Plasmaprotein

können sich subkutane Ödeme bilden, vor allem unter dem Kiefer.

Es gibt kein spezielles Gegenmittel. Bei Anzeichen einer möglichen Überdosierung ist das Tier

symptomatisch zu behandeln.

Inkompatibilitäten

Dieses Präparat nicht mit anderen Tierarzneimitteln mischen.

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON NICHT

VERWENDETEM ARZNEIMITTEL ODER VON ABFALLMATERIALIEN, SOFERN

ERFORDERLICH

DE: Nicht aufgebrauchte Tierarzneimittel sind vorzugsweise bei Schadstoffsammelstellen abzugeben.

Bei gemeinsamer Entsorgung mit dem Hausmüll ist sicherzustellen, dass kein missbräuchlicher Zugriff

auf diese Abfälle erfolgen kann. Tierarzneimittel dürfen nicht mit dem Abwasser bzw. über die

Kanalisation entsorgt werden.

AT/BE: Nicht verwendete Tierarzneimittel oder davon stammende Abfallmaterialien sind entsprechend

den nationalen Vorschriften zu entsorgen.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

November 2014

15.

WEITERE ANGABEN

Liste der Packungsgrößen:

- Pappschachtel mit 20 oder 100 Beuteln mit je 5 Gramm des Präparats.

BE-V437044 (Alu/LDPE/papier/LDPE Beutel)

Bijsluiter – DE Versie

BUTAGRAN EQUI

BE-V437035 (PET/LDPE/Alu/LDPE Beutel)

DE/BE: Verschreibungspflichtig.

AT: Rezept- und apothekenpflichtig

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Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

24-10-2018

U-Pol Inc. recalls Automotive Repair and Refinish Products

U-Pol Inc. recalls Automotive Repair and Refinish Products

Health Canada has established that these products do not meet the mandatory warning labelling requirements for consumer use, as required under Canadian law. They are correctly labelled for workplace professional users, but the products lack the symbols and warnings required for consumer chemicals.

Health Canada

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

19-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, fresh-cut produce processors more effectively comply with food safety requirements

FDA - U.S. Food and Drug Administration

18-10-2018

CTG recalls Friction Powered School Bus

CTG recalls Friction Powered School Bus

Health Canada's sampling and evaluation program has determined that the school bus toy does not meet Canadian safety requirements for toys. Specifically, the school bus released small parts during testing, which are a choking hazard for young children.

Health Canada

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

FDA Warns Two Firms about Monensin Contamination in Horse Feed

FDA Warns Two Firms about Monensin Contamination in Horse Feed

FDA has issued warning letters to two feed mills that mixed horse feed containing monensin, an animal drug that is toxic and potentially lethal to horses. This should be a reminder to all feed manufacturers making medicated feeds that they must remain vigilant about adhering to CGMP requirements.

FDA - U.S. Food and Drug Administration

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

15-10-2018

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Health Canada's sampling and evaluation program has determined the Barrel-O-Slime toy does not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

4-10-2018

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

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

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Garderie Dépôt recalls Dream on Me Portable Cribs

Garderie Dépôt recalls Dream on Me Portable Cribs

The distance between the top surface of the lowest fixed side and the top surface of the mattress support is lower than what is required by law, posing a fall hazard.

Health Canada

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 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 cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) 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...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 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 tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Siu & Sons Int'l Trading recalls Color Fantastik Assorted Rubber Animal Toys

Siu & Sons Int'l Trading recalls Color Fantastik Assorted Rubber Animal Toys

Health Canada's sampling and evaluation program has determined that the rubber animals do not meet the Canadian safety requirements for toys. The squeakers inside the rubber animals can be easily removed; these small parts pose a choking hazard to young children.

Health Canada

19-9-2018

Exclusive Brands and iSweet recall Kidsmania Bubble Dozer

Exclusive Brands and iSweet recall Kidsmania Bubble Dozer

Health Canada's sampling and evaluation program has determined that these products do not meet the Canadian safety requirements for toys.Small parts can break off the toys, posing a choking hazard to young children.

Health Canada

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate 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 the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin 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 the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

21-10-2018

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed h

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed h

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed health decisions.

FDA - U.S. Food and Drug Administration