Fiprex CAT 52,5 mg

Hauptinformation

  • Handelsname:
  • Fiprex CAT 52,5 mg Lösung zum Auftropfen 75 mg/ml
  • Dosierung:
  • 75 mg/ml
  • Darreichungsform:
  • Lösung zum Auftropfen
  • 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:
  • Fiprex CAT 52,5 mg Lösung zum Auftropfen 75 mg/ml
    Belgien
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V501946
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Notice – Version DE

FIPREX CAT 52,5 MG

GEBRAUCHSINFORMATION FÜR

Fiprex CAT 52,5 mg Lösung zum Auftropfen für Katzen

1.

NAME

UND

ANSCHRIFT

DES

ZULASSUNGSINHABERS

UND,

WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE CHARGENFREIGABE

VERANTWORTLICH IST

Zulassungsinhaber

VET-AGRO TRADING Sp. z o.o.

ul. Mełgiewska 18

20-234 Lublin

Polen

Für die Chargenfreigabe verantwortlicher Hersteller:

Przedsiębiorstwo Wielobranżowe Vet-Agro Sp. z o.o.

ul. Gliniana 32, 20-616 Lublin

Polen

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

Fiprex CAT 52,5 mg Lösung zum Auftropfen für Katzen

Fipronil

3.

WIRKSTOFF UND SONSTIGE BESTANDTEILE

Eine Pipette (0,7 ml) enthält:

Wirkstoff:

Fipronil

52,5 mg

Hilfsstoffe:

Butylhydroxytoluol (E 321)

2,1 mg

Butylhydroxyanisol (E 320)

2,1 mg

Hellgelbe bis intensiv gelbe Lösung.

4.

ANWENDUNGSGEBIET(E)

Zur Behandlung von Flohbefall (Ctenocephalides felis) und Zeckenbefall (Dermacentor reticulatus).

Das Tierarzneimittel zeigt eine sofortige insektizide Wirkung und besitzt eine bis zu 9 Tagen

anhaltende insektizide Wirksamkeit gegenüber einem erneuten Befall mit adulten Flöhen.

Die akarizide Wirkung gegen Dermacentor reticulatus hält bis zu 2 Wochen an. Wenn Zecken dieser

Art zum Zeitpunkt der Behandlung bereits am Tier vorhanden sind, werden nicht alle innerhalb der

ersten 48 Stunden nach dem Auftragen abgetötet, sie können aber innerhalb einer Woche abgetötet

werden.

5.

GEGENANZEIGEN

Das Tierarzneimittel soll bei Katzen die jünger als 2 Monate und/oder leichter als 1 kg sind, nicht

angewendet werden.

Nicht bei kranken (z. B. systemische Erkrankungen, Fieber) oder rekonvaleszenten Tieren anwenden.

Nicht bei Kaninchen anwenden, da Nebenwirkungen und sogar Tod die Folge sein können.

Nicht bei Überempfindlichkeiten gegenüber dem Wirkstoff oder einem der übrigen Bestandteile

anwenden.

Nicht auf die verletzte Tierhaut auftragen.

Notice – Version DE

FIPREX CAT 52,5 MG

6.

NEBENWIRKUNGEN

Nach Ablecken der Applikationsstelle können Hypersalivation, Erbrechen oder neurologische

Symptome (Überempfindlichkeit oder Lethargie) ausnahmsweise auftreten.

An der Applikationsstelle kann man sehr selten Entfärbung des Fells, lokalen Haarverlust, Irritation

oder Juckreiz beobachten.

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)

Katze.

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Applikationsart und Dosierung:

Applikation– zum Auftropfen.

Eine Pipette (0,7 ml) mit 52,5 mg Fipronil pro Katze.

Art der Anwendung:

Die Pipettenkappe knicken. Scheiteln Sie das Fell zwischen den Tierschultern, dass die Haut sichtbar

wird. Setzen Sie die Pipettenspitze auf die Haut und drücken Sie die Pipette leicht, um den

Pipetteninhalt direkt auf die Haut aufzutragen.

Notwendigerweise soll das Produkt an mehreren Stellen zwischen Schulterblätter appliziert werden,

was das Verlustrisiko minimalisieren und garantieren kann, dass die ganze Dosis verabreicht wurde.

Wegen mangelnder Studien über die Sicherheit wird empfohlen, einen Minimalabstand von 4 Wochen

zwischen den Applikationen zu beachten.

Die örtliche epidemiologische Situation soll berücksichtigt werden.

Die Anwendung dieses Mittels soll den individuellen Bedürfnissen der Katze unter Berücksichtigung

des möglichen Flohbefalls, der Lebensweise des Tieres und örtlichen epidemiologischen Situation

angepasst und ausschließlich beim drohenden Flohbefall angewendet werden.

Durch Beachtung von Anweisungen und Warnhinweisen des Herstellers wird das Risiko der

Nebenwirkungen auf ein Minimum reduziert werden.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren

Wichtig ist, das Tierarzneimittel auf Stellen aufzutragen, die vom Tier nicht abgeleckt werden können.

10.

WARTEZEIT

Nicht zutreffend.

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel unzugänglich für Kinder aufbewahren.

Nicht über 25°C lagern. Nicht im Kühlschrank lagern.

Nach dem auf der Pipette und Kartonschachtel befindlichen Verfalldatum nicht verwenden.

Nach erstmaligem Öffnen sofort verbrauchen.

12.

BESONDERE WARNHINWEISE

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren

Notice – Version DE

FIPREX CAT 52,5 MG

Fiprex zeigt eine kurzfristige, sich anhaltende Wirkung gegenüber einem Flohbefall und darf

deswegen zur Kontrollbehandlung der flohallergischen Dermatitis (FAD) nicht angewendet werden.

Es wurden keine sicherheitsorientierten Untersuchungen des Produktes bei mehrmaliger Applikation

durchgeführt, weil das Sicherheitsprofil sowohl des Wirk- als auch des Hilfsstoffes bekannt ist; bei den

die Sicherheit von Tieren: Katzen und Katzenjungs im Alter von wenigstens 8 Wochen und

Körpergewicht von ca. 1 kg, denen die empfohlene Dosis einmal pro Monat über 6 aufeinander

folgende Monate fünfmal appliziert wurde, betreffenden Untersuchungen hat man jedoch hat keine

unerwünschten Wirkungen beobachtet. Im Fall mangelnder Studien über die Sicherheit wird

empfohlen, einen Minimalabstand von 4 Wochen zwischen den Applikationen zu beachten.

Das Tier soll die Auftragungsstelle des Tierarzneimittels einige Stunden nach dessen Auftragung nicht

lecken. Es ist wichtig, darauf zu achten, dass sich behandelte Tiere nicht gegenseitig ablecken können.

Nur zur äußerlichen Anwendung geeignet.

Dieses Tierarzneimittel wurde speziell für Katzen entwickelt. Nicht bei Hunden anwenden.

Der Kontakt des Arzneimittels mit den Augen des behandelten Tieres soll vermieden werden. Ist es

jedoch dazu gekommen, sollen die Augen sofort reichlich mit dem Wasser gewaschen werden.

Nicht auf die verletzte Tierhaut auftragen.

Alle in einem Haushalt lebende Hunde und Katzen sollten gleichzeitig behandelt werden

Es liegen keine Daten über den Einfluss des Badens oder Shampoonierens auf die Wirksamkeit des

Tierarzneimittels bei Katzen vor. Daher soll das behandelte Tier innerhalb von 48 Stunden nach dem

Auftragen des Arzneimittels nicht gebadet oder ins Wasser eingetaucht sowie dann nicht häufiger als

einmal pro Woche gebadet werden.

Flöhe können durch Tiere an die Stellen, mit denen sie in Berührung kommen, das heißt an deren

Schlafplätze, Fußbodenbeläge, Teppiche, wo sie regelmäßig ausruhen, übertragen werden . Diese

Einrichtungen sollten regelmäßig entstaubt und ab Anfang der Kontrollmaßnahmen mit

entsprechenden Insektiziden behandelt werden.

Zur optimalen Beseitigung des Flohproblems in einem Haushalt mit mehreren Tieren sollten alle

Hunde und Katzen gleichzeitig behandelt werden.

Besondere Vorsichtsmaßnahmen für den Anwender

Bis zur Anwendungszeit sollen Pipetten in der Originalverpackung aufbewahrt werden.

Personen mit bekannter Überempfindlichkeit gegenüber Fipronil oder einem der übrigen Bestandteile

sollten den Kontakt mit dem Tierarzneimittel vermeiden.

Den Kontakt des Inhalts mit der Haut vermeiden. Bei Hautkontakt mit Wasser und Seife waschen.

Das Tierarzneimittelt kann die Schleimhaut und Augen reizen. Der Kontakt dieses Arzneimittels mit

Mund und Augen soll vermieden werden. Nach versehentlichem Kontakt mit dem Auge dieses sofort

sorgfältig mit klarem Wasser ausspülen. Sofern die Augenreizung bestehen bleibt, ist unverzüglich ein

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

Das Verschlucken des Mittels ist gefährlich. Pipetten sollen vor Kindern geschützt und sofort nach

Applikation entsorgt werden. Wenn das Tierarzneimittel versehentlich geschluckt wird, sofort einen

Arzt aufsuchen.

Den Kontakt mit dem behandelten Tier vermeiden, bevor die Applikationsstelle trocken ist.

Kinder dürfen mit dem behandelten Tier nicht spielen, bevor die Applikationsstelle trocken ist. Es wird

daher empfohlen, Tiere nicht während des Tages, sondern am frühen Abend zu behandeln. Darüber

hinaus sollten frisch behandelte Tiere nicht bei den Besitzern, insbesondere Kindern, schlafen.

Notice – Version DE

FIPREX CAT 52,5 MG

Während der Anwendung nicht rauchen, trinken oder essen.

Hände nach jeder Anwendung sorgfältig waschen.

Andere Vorsichtsmaßnahmen

Das Produkt kann bemalte, lackierte und andere Oberflächen im Haushalt,z.B. Möbel, beschädigen.

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON NICHT

VERWENDETEN ARZNEIMITTELN ODER VON ABFALLMATERIALIEN, SOFERN

ERFORDERLICH

Nicht verwendetes Tierarzneimittel oder davon stammende Abfallmaterialien sind entsprechend den

örtlichen Vorschriften zu entsorgen.

Fipronil kann die Wasserorganismen ungünstig beeinflussen. Gewässer, und Abwasserkanäle dürfen

mit dem vorliegenden Tierarzneimittel oder dessen Verpackung nicht verunreinigt werden.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

Februar2017

15.

ANDERE INFORMATIONEN

Überdosierung

Im Falle einer Überdosierung kann das Risiko des Auftretens von Unverträglichkeiten steigen.

Die Überdosierung kann Muskelkrämpfe und Konvulsionen nach sich ziehen.

In vereinzelten Fällen beobachtet man Erregungszustände, Schläfrigkeit und Überempfindlichkeit

gegen Lärm und Licht. Ebenfalls wurden vorübergehend Schwindel, übermäßiger Speichelfluss und

Erbrechen beobachtet.

An der Auftragungsstelle kann eine vorübergehende Hautrötung und –reizung auftreten.

Deren Intensität kann durch eine symptomatische Behandlung reduziert werden.

Das Risiko der Nebenwirkungen kann dennoch im Fall einer Überdosierung steigen,

man soll also darauf achten, damit die Pipette von entsprechender dem Körpergewicht und den

Zeitabständen angepassten Größe verwendet wird. Bei eventuellen Zweifeln soll man sich von einem

Veterinärarzt beraten lassen.

Anwendung während der Trächtigkeit und Laktation oder der Legeperiode

In den Laboruntersuchungen an Tieren wurde weder teratogene noch embryotoxische Wirkung

nachgewiesen. Es wurden keine Studien mit dem vorliegenden Tierarzneimittel an trächtigen oder

säugenden Katzen durchgeführt. Daher sollte eine Anwendung während der Trächtigkeit und Laktation

nur nach entsprechender Nutzen-Risiko-Bewertung durch den behandelnden Tierarzt erfolgen.

LDPE/HDPE-Pipette 0,7 ml mit HDPE-Kappe, in der Kartonschachtel.

LDPE/HDPE-Pipette 0,7 ml mit HDPE-Kappe, 3 Pipetten in der Kartonschachtel.

LDPE/HDPE-Pipette 0,7 ml mit HDPE-Kappe, 12 Kartonschachteln in einer Kartonpackung.

Es werden möglicherweise nicht alle Packungsgrößen in Verkehr gebracht.

Vorhandene Verpackungen:

1x 0,7 ml, 3x 0,7 ml, 12x 0,7ml.

ZULASSUNGSNUMMER:

BE-V501946

Rezeptfrei.

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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

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

FDA - U.S. Food and Drug Administration

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

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

1-10-2018

Public Notification: Shengan Natural Model contains hidden drug ingredient

Public Notification: Shengan Natural Model contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Shengan Natural Model, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: USA for Women contains hidden drug ingredient

Public Notification: USA for Women contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use USA for Women, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: In Shape contains hidden drug ingredient

Public Notification: In Shape contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use In Shape, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

Public Notification: ProSolution contains hidden drug ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Baschi Quick Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: V-Max contains hidden drug ingredient

Public Notification: V-Max contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use V-Max, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Strong Horses contains hidden drug ingredient

Public Notification: Strong Horses contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Strong Horses, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Green Lean Body Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Like Slim Coffee contains hidden drug ingredient

Public Notification: Like Slim Coffee contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Like Slim Coffee, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

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

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications.

FDA - U.S. Food and Drug Administration

14-9-2018

Minister van Sport Bruno Bruins aanwezig bij MXGP Assen

Minister van Sport Bruno Bruins aanwezig bij MXGP Assen

Dit weekend staat de Motorcross Grand Prix (MXGP) op het TT circuit van Assen op de agenda. Dit jaar kan een bijzondere editie worden, omdat Jeffrey Herlings de mogelijkheid heeft om de eerste Nederlandse wereldkampioen in de MXGP-categorie te worden.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

11-9-2018

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

Health Canada

11-9-2018

Radagast Pet Food, Inc. recalls various Rad Cat Raw Diet Pet Food

Radagast Pet Food, Inc. recalls various Rad Cat Raw Diet Pet Food

The recalled pet food may be contaminated with Listeria monocytogenes and there is risk of cross contamination and illness after handling the pet food.

Health Canada

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

8-9-2018

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms is recalling Cage Free Large Eggs due to a potential contamination of Salmonella. The recall was initiated because reported illnesses were confirmed at locations using Gravel Ridge Farm Eggs, and we are voluntarily recalling out of an abundance of caution.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use PremierZen Gold 4000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test   for detecting genetic variants that may be associated with medication   metabolism? Learn more about the authorization:  https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

1-11-2018

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here:  https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.usa.gov/xPysF  #MedicalDevice

FDA - U.S. Food and Drug Administration

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

25-9-2018

Brilique (AstraZeneca AB)

Brilique (AstraZeneca AB)

Brilique (Active substance: ticagrelor) - PSUSA - Modification - Commission Decision (2018)6282 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1241/PSUSA/2948/201712

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

24-9-2018

Lumark (IDB Holland B.V.)

Lumark (IDB Holland B.V.)

Lumark (Active substance: lutetium, isotope of mass 177) - PSUSA - Modification - Commission Decision (2018)6212 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010391/201712

Europe -DG Health and Food Safety

19-9-2018

Stelara (Janssen-Cilag International NV)

Stelara (Janssen-Cilag International NV)

Stelara (Active substance: ustekinumab) - PSUSA - Modification - Commission Decision (2018)6102 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00003085/201712

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency