Compo Muffa-Stop

Hauptinformation

  • Handelsname:
  • Compo Muffa-Stop
  • Verwenden für:
  • Pflanzen
  • Art der Medizin:
  • Agrochemisch

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:
  • Compo Muffa-Stop
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Fungizid

Weitere Informationen

Status

  • Quelle:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Zulassungsnummer:
  • I-2731
  • Letzte Änderung:
  • 06-09-2017

Packungsbeilage

Produkt:

Handelsbezeichnung: Compo Muffa-Stop (Parallelimport)

Produktekategorie

Ausl. Bewilligungsinhaber Eidg. Zulassungsnummer

Fungizid

Compo Agricultura SPA

I-2731

Packungsbeilagenummer Herkunftsland

Ausl. Zulassungsnummer

6113

Italien

12322

Stoff(e)

Gehalt

Formulierungscode

Wirkstoff: Cyprodinil

37.5 %

WG Wasserdispergierbares Granulat

Wirkstoff: Fludioxonil

25 %

Anwendungen

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

B Brombeere

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

Aufwandmenge: 1 kg/ha

Wartefrist: 2 Woche(n)

1, 2, 3, 4, 5

B Erdbeere

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

Aufwandmenge: 1 kg/ha

Wartefrist: 2 Woche(n)

4, 5, 6, 7

B Heidelbeere

Graufäule (Botrytis cinerea)

Zweig- und Beerenkrankheit

Konzentration: 0.1 %

Aufwandmenge: 1 kg/ha

Wartefrist: 7 Tage

1, 2, 4, 5, 8

B Himbeere

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

Aufwandmenge: 1 kg/ha

Wartefrist: 2 Woche(n)

1, 2, 4, 5, 9

Rote Johannisbeere

Schwarze

Johannisbeere

Mondscheinigkeit

Konzentration: 0.1 %

Aufwandmenge: 1 kg/ha

Wartefrist: 7 Tage

1, 2, 4, 5, 8

B Stachelbeere

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

1, 2, 4, 5, 8

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Mondscheinigkeit

Aufwandmenge: 1 kg/ha

Wartefrist: 7 Tage

Aprikose

Pfirsich / Nektarine

Zwetschge / Pflaume

Blüten- und Zweigdürre

Konzentration: 0.06 %

Aufwandmenge: 1 kg/ha

Wartefrist: 3 Woche(n)

Anwendung: Während der Blüte.

2, 5, 10, 13

O Aprikose

Blüten- und Zweigdürre

Konzentration: 0.06 %

Aufwandmenge: 1 kg/ha

Wartefrist: 3 Woche(n)

Anwendung: Während der Blüte.

10, 11, 12,

13, 14

Aprikose

Pfirsich / Nektarine

Zwetschge / Pflaume

Fruchtmonilia

Konzentration: 0.06 %

Aufwandmenge: 1 kg/ha

Wartefrist: 3 Woche(n)

Anwendung: Ab Stadium 71-72 und

77-79.

2, 5, 10, 13

W Reben

Graufäule (Botrytis cinerea)

Konzentration: 0.1 %

Aufwandmenge: 1.2 kg/ha

2, 5, 13,

15, 16, 17

Aubergine

Tomaten

Graufäule (Botrytis cinerea)

Sclerotinia-Fäule

Konzentration: 0.1 %

Wartefrist: 3 Tage

2, 4, 5, 18

G Bohnen

Graufäule (Botrytis cinerea)

Sclerotinia-Fäule

Aufwandmenge: 0.5 - 0.8 kg/ha

Wartefrist: 2 Woche(n)

4, 5, 18

G Chicorée

Graufäule (Botrytis cinerea)

Sclerotinia-Fäule

Aufwandmenge: 36 g/Tonne

Anwendung: Vor der Einlagerung.

5, 13, 19,

21, 22

G Chicorée

Graufäule (Botrytis cinerea)

Sclerotinia-Fäule

Aufwandmenge: 90 g/hl

Anwendung: Vor der Einlagerung.

5, 13, 20,

21, 22

G Chicorée

Graufäule (Botrytis cinerea)

Sclerotinia-Fäule

Aufwandmenge: 4.5 g/m²

Wartefrist: 21 Tage

Anwendung: Zu Beginn der Treiberei.

5, 13, 21,

G Erbsen

Brennfleckenkrankheit der

Erbse

Graufäule (Botrytis cinerea)

Sclerotinia-Fäule

Aufwandmenge: 1 kg/ha

Wartefrist: 14 Tage

4, 5, 23

G Gurken

Graufäule (Botrytis cinerea)

Sclerotinia-Fäule

Konzentration: 0.1 %

Wartefrist: 3 Tage

2, 4, 5, 18

G Nüsslisalat

Graufäule (Botrytis cinerea)

Rhizoctonia-solani-Krankheit

Aufwandmenge: 0.6 kg/ha

Wartefrist: 35 Tage

Anwendung: Behandlung bis

spätestens 14 Tage nach der

Pflanzung.

4, 5, 24

G Rucola

Graufäule (Botrytis cinerea)

Aufwandmenge: 0.5 - 0.7 kg/ha

4, 5, 24, 25

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Sclerotinia-Fäule

Wartefrist: 14 Tage

G Salate (Asteraceae)

Graufäule (Botrytis cinerea)

Rhizoctonia-solani-Krankheit

Sclerotinia-Fäule

Aufwandmenge: 0.5 - 0.8 kg/ha

Anwendung: Behandlung bis

spätestens 14 Tage nach der

Pflanzung.

4, 5, 18, 24

G Spargel

Graufäule (Botrytis cinerea)

Aufwandmenge: 1 kg/ha

Anwendung: Nach der Ernte.

4, 5, 26

G Zwiebeln

Blattbotrytis der Zwiebel

Aufwandmenge: 1 kg/ha

Wartefrist: 2 Woche(n)

4, 5, 18, 24

G Zwiebeln

Mehlkrankheit der Zwiebel

Aufwandmenge: 1 kg/ha

Anwendung: 1. Behandlung im 2-

Blattstadium, 2. Behandlung 3

Wochen später (bei Herbstsaat im

Frühjahr).

4, 5, 24

Bäume und

Sträucher

(ausserhalb Forst)

Rosen

Graufäule (Botrytis cinerea)

Konzentration: 0.1 - 0.12 %

1, 2, 4, 5,

Blumenkulturen und

Grünpflanzen

Graufäule (Botrytis cinerea)

Konzentration: 0.1 - 0.12 %

1, 4, 5, 13

Buchsbäume

(Buxus)

Cylindrocladium-Trieb- und

Blattsterben

Konzentration: 0.1 %

Anwendung: Ab Mitte April bis

Oktober.

4, 5, 13,

27, 28

Z Zier- und Sportrasen Schneeschimmel

Aufwandmenge: 1.5 kg/ha

1, 5

Auflagen und Bemerkungen:

Maximal 2 Behandlungen pro Parzelle und Jahr.

SPe 3: Zum Schutz von Gewässerorganismen vor den Folgen von Drift eine unbehandelte

Pufferzone von 20 m zu Oberflächengewässern einhalten. Diese Distanz kann beim Einsatz von

driftreduzierenden Massnahmen gemäss den Weisungen des BLW reduziert werden.

Für Brombeeren bezieht sich die angegebene Aufwandmenge auf Stadium "Erste Blüten bis etwa

50% der Blüten offen" sowie eine Referenzbrühmenge von 1000 l/ha.

Bei Anwendung im Gewächshaus ist dieses vor dem Wiederbetreten gründlich zu lüften.

Ansetzen der Spritzbrühe: Schutzhandschuhe tragen. Ausbringen der Spritzbrühe:

Schutzhandschuhe + Schutzanzug + Visier + Kopfbedeckung tragen. Technische

Schutzvorrichtungen während des Ausbringens (z.B. geschlossene Traktorkabine) können die

vorgeschriebene persönliche Schutzausrüstung ersetzen, wenn gewährleistet ist, dass sie einen

vergleichbaren oder höheren Schutz bieten.

Maximal 2 Behandlungen pro Kultur und Jahr.

Die angegebene Aufwandmenge bezieht sich auf Stadium "Vollblüte bis Beginn Rotfärbung der

Früchte", 4 Pflanzen pro m² sowie eine Referenzbrühmenge von 1000 l/ha.

Die angegebene Aufwandmenge bezieht sich auf Stadium "50 - 90% der Blütenstände mit

sichtbaren Früchten" sowie eine Referenzbrühmenge von 1000 l/ha.

Für Sommerhimbeeren bezieht sich die angegebene Aufwandmenge auf Stadium "Erste Blüten bis

etwa 50% der Blüten offen" sowie eine Referenzbrühmenge von 1000 l/ha. Für Herbsthimbeeren

bezieht sich die Aufwandmenge auf eine Heckenhöhe von 150 - 170 cm sowie eine

Referenzbrühmenge von 1000 l/ha.

10.Die angegebene Aufwandmenge bezieht sich auf ein Baumvolumen von 10'000 m³ pro ha.

11.Maximal 2 Luftapplikationen pro Jahr.

12.Luftapplikation.

13.Nachfolgearbeiten in behandelten Kulturen: bis 48 Stunden nach Ausbringung des Mittels

Schutzhandschuhe + Schutzanzug tragen.

14.Ansetzen der Spritzbrühe: Schutzhandschuhe tragen.

15.Letzte Behandlung bei Beginn des Farbumschlags, jedoch spätestens Mitte August.

16.Maximal 1 Behandlung pro Parzelle und Jahr.

17.Die angegebene Aufwandmenge bezieht sich auf eine Behandlung der Traubenzone sowie eine

Referenzbrühmenge von 1200 l/ha (Berechnungsgrundlage).

18.Maximal 2 Behandlungen pro Kultur.

19.Spritzen.

20.Tauchbehandlung.

21.Maximal 1 Behandlung pro Produktionszyklus.

22.Nach Abschluss der Behandlungszeit: Raum vor dem Wiederbetreten gründlich lüften

23.Maximal 2 Behandlungen pro Kultur im Abstand von 10 Tagen.

24.SPe 3: Zum Schutz von Gewässerorganismen vor den Folgen einer Abschwemmung eine mit

einer geschlossenen Pflanzendecke bewachsene unbehandelte Pufferzone von mindestens 6 m zu

Oberflächengewässern einhalten. Ausnahmen sind in den Weisungen des BLW festgelegt.

25.Maximal 3 Behandlungen pro Kultur.

26.Maximal 3 Behandlungen pro Parzelle und Jahr.

27.SPa 1: Zur Vermeidung einer Resistenzbildung maximal 4 Behandlungen pro Parzelle und Jahr

mit Produkten aus derselben Wirkstoffgruppe.

28.Behandlungen im Abstand von 4 Wochen.

Gefahrenkennzeichnungen:

Es gilt die Einstufung und Kennzeichnung der ausländischen Originaletikette.

Zusätzliche Schweizerische Gefahrenkennzeichnungen:

SP 1 Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen.

Im Zweifelsfall gelten einzig die Originaldokumente der Zulassung. Die Erwähnung eines Produktes,

Wirkstoffes oder einer Firma stellt keine Empfehlung dar und bedeutet nicht, dass sich das Produkt im

Verkauf befindet.

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

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding

FDA - U.S. Food and Drug Administration

21-9-2018

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

CVM Update describing FDA Dear Veterinarian Letter about the differences between FDA-approved Mirataz (mirtazapine transdermal ointment), an animal drug with demonstrated safety and effectiveness to manage undesired weight loss in cats, and compounded formulations of transdermal mirtazapine.

FDA - U.S. Food and Drug Administration

20-9-2018

Cybex International Inc. Recalls Cybex Smith Press

Cybex International Inc. Recalls Cybex Smith Press

A fall hazard has been identified when a user has not fully engaged the weight bar hooks over the pins and has not set the safety stops, permitting the bar to fall near a user. Potential injuries range from minor to significant including paralysis, spinal fracture and injuries to the head and neck.

Health Canada

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

7-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

23-8-2018

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

FDA announced that all 17 manufacturers, distributors, and retailers that were warned in May have stopped selling the e-liquids used in e-cigarettes with labeling or advertising resembling kid-friendly food products.

FDA - U.S. Food and Drug Administration

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues making progress on bulk drug substances for compounding

FDA - U.S. Food and Drug Administration

17-7-2018

New York-based food processors agree to stop food preparation operations due to food safety violations

New York-based food processors agree to stop food preparation operations due to food safety violations

New York-based food processors agree to stop food preparation operations due to food safety violations

FDA - U.S. Food and Drug Administration

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online

FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online

FDA - U.S. Food and Drug Administration

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

FDA - U.S. Food and Drug Administration

25-6-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

FDA Commissioner Scott Gottlieb, M.D., discusses the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components.

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

6-6-2018

CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.

FDA - U.S. Food and Drug Administration

5-6-2018

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

FDA - U.S. Food and Drug Administration

5-6-2018

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

FDA - U.S. Food and Drug Administration

1-6-2018

HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller

HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller

Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.

FDA - U.S. Food and Drug Administration

1-6-2018

Specialized Bicycle Components Canada, Inc. recalls Bicycles with Stout Crankarms

Specialized Bicycle Components Canada, Inc. recalls Bicycles with Stout Crankarms

The crankarm can disengage and cause the rider to lose control, posing fall and injury hazards.

Health Canada

31-5-2018

LFIT Anatomic CoCr V40 Femoral Heads

LFIT Anatomic CoCr V40 Femoral Heads

Hazard alert - potential for components to separate

Therapeutic Goods Administration - Australia

30-5-2018

Procleix West Nile Virus (WNV) Assay

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

28-5-2018

Calgodip Germ Stop ad us. vet., Zitzendesinfektionsmittel

Calgodip Germ Stop ad us. vet., Zitzendesinfektionsmittel

● Die Zulassung ist am 28.05.2018 erloschen.

Institut für Veterinärpharmakologie und toxikologie

26-5-2018

Stop & Shop Voluntarily Recalls Stop & Shop Frozen Broccoli Cuts

Stop & Shop Voluntarily Recalls Stop & Shop Frozen Broccoli Cuts

Stop & Shop is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution due to our supplier notifying us the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

25-5-2018

Urgent Medical Device Recall: Sam XT Extremity Tourniquet

Urgent Medical Device Recall: Sam XT Extremity Tourniquet

SAM Medical today announced it is conducting a voluntary international recall of all unused SAM XT Extremity Tourniquets (SAM XT). The company initiated the recall after internal testing indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. To date, there have been no reports of adverse health consequences received. This recall is being made with the knowledge of the Food and Drug A...

FDA - U.S. Food and Drug Administration

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

22-5-2018

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

FDA - U.S. Food and Drug Administration

10-5-2018

FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

FDA - U.S. Food and Drug Administration

9-5-2018

FDA seeks permanent injunctions against two stem cell clinics

FDA seeks permanent injunctions against two stem cell clinics

FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

12-10-2017

MAHs should not submit ICSRs and SUSARs to IMA during EudraVigilance downtime from 8 to 21
November 2017

MAHs should not submit ICSRs and SUSARs to IMA during EudraVigilance downtime from 8 to 21 November 2017

The correct arrangement is that during the aforementioned scheduled downtime of EudraVigilance, from 8 to 21 November 2017, MAHs should stop submitting ICSRs and SUSARs to the agency

IMA - Icelandic Medicines Agency

1-4-2014

Danish Pharmacovigilance Update 27 February 2014

Danish Pharmacovigilance Update 27 February 2014

In this issue of Danish Pharmacovigilance Update: Further restrictions on the use of osteoporosis medicine strontium ranelate (Protelos®), Anticoagulant therapy to be stopped before initiating treatment with the new oral anticoagulants (NOACs).

Danish Medicines Agency

27-3-2012

Illegal potency-enhancing drug in Denmark: Viamax Pure Power

Illegal potency-enhancing drug in Denmark: Viamax Pure Power

The Danish National Board of Health has received information about the dangerous potency-enhancing product Viamax Pure Power, which is sold by Danish online shops. Viamax Pure Power is not an authorised medicinal product, and we therefore warn consumers not to use the product. We advise consumers who have taken Viamax Pure Power to stop using it and to contact their doctor if they have any concerns. The illegal medicinal product may be handed over to a pharmacy for destruction.

Danish Medicines Agency

20-6-2011

Warning against the tanning product Melanotan

Warning against the tanning product Melanotan

The Danish Medicines Agency repeats its warning against using the illegal product Melanotan because its effect is not documented and because of the absence of studies of its potential side effects. The Danish Medicines Agency urges everyone who uses Melanotan to stop using it and to contact their doctor if concerned.

Danish Medicines Agency

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

12-10-2018

The 2nd week of National Cybersecurity Awareness Month is here! This  week’s theme: “Cybersecurity = A Cross-Cutting Challenge to Tackle  Together”. Learn more about #NCSAM at   https://www.dhs.gov/stopthinkconnect …. #FDA #MedicalDevicespic.twitter.com/H

The 2nd week of National Cybersecurity Awareness Month is here! This week’s theme: “Cybersecurity = A Cross-Cutting Challenge to Tackle Together”. Learn more about #NCSAM at https://www.dhs.gov/stopthinkconnect …. #FDA #MedicalDevicespic.twitter.com/H

The 2nd week of National Cybersecurity Awareness Month is here! This week’s theme: “Cybersecurity = A Cross-Cutting Challenge to Tackle Together”. Learn more about #NCSAM at https://www.dhs.gov/stopthinkconnect …. #FDA #MedicalDevices pic.twitter.com/H3rUbSyLPq

FDA - U.S. Food and Drug Administration

27-9-2018

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq  pic.twitter.com/LT9SptJge1

FDA - U.S. Food and Drug Administration

22-7-2018

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda …

FDA - U.S. Food and Drug Administration

20-7-2018

Bayer to stop #Essure sales in the U.S.  https://go.usa.gov/xUnaA  #MedicalDevice

Bayer to stop #Essure sales in the U.S. https://go.usa.gov/xUnaA  #MedicalDevice

Bayer to stop #Essure sales in the U.S. https://go.usa.gov/xUnaA  #MedicalDevice

FDA - U.S. Food and Drug Administration