Cythrin 500

Primær information

  • Handelsnavn:
  • Cythrin 500 Emulsionskoncentrat
  • Lægemiddelform:
  • Emulsionskoncentrat
  • Sammensætning:
  • 500 g/l cypermethrin (cis:trans 40:60)
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for sundhedspersonale:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for sundhedspersonale.

Lokation

  • Fås i:
  • Cythrin 500 Emulsionskoncentrat
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Ikke længere markedsført
  • Autorisationsnummer:
  • Må ikke anvendes nærmere end 20 meter fra vandmiljøet (vandløb, søer m.v.) for at beskytte organismer, der lever i vand.
  • Sidste ændring:
  • 22-07-2018

Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning

ADVARSEL

For at nedsætte risikoen for mennesker og miljø skal brugsanvisningen følges nøje.

Farlig ved indånding (R20).

Irriterer huden (R38).

Meget giftig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i

vandmiljøet (R50/53).

Undgå indånding af aerosoltåger.

Brug af egnede beskyttelseshandsker.

Vask huden efter arbejdet.

Vær opmærksom på, at Arbejdstilsynet har regler for arbejde med og udsættelse for

plantebeskyttelsesmidler. Læs nærmere i det eventuelt lovpligtige sikkerhedsdatablad samt

i Arbejdstilsynets informationsmateriale om bekæmpelsesmidler.

Emballagen må ikke genbruges.

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre straf:

Må kun anvendes til bekæmpelse af insekter i hvede, rug, triticale, byg, havre, majs,

raps, rybs, sennep, ærter, kartofler, bederoer, hovedsalat, persille, dild, broccoli,

blomkål, rosenkål, savojkål, hvidkål, rødkål, gulerod, knoldselleri, radise, skorzoner-

rod, peberrod, pastinak og persillerod.

Må ikke anvendes mod andre skadevoldere og

ikke i højere doseringer end de i brugsanvisningen nævnte.

Må kun anvendes 1 gang årligt.

Må i kartofler, peberrod, persillerod, pastinak, skorzonerrod, knoldselleri, radise,

hovedsalat, persille, dild, broccoli, blomkål, rosenkål, savojkål, hvidkål og rødkål

ikke anvendes senere end 7 dage før høst.

Må i ærter m. bælg, ærter u. bælg og majs ikke anvendes senere end 14 dage før høst.

Må i korn ikke anvendes senere end 21 dage før høst.

Må i bederoer ikke anvendes senere end 14 dage før høst.

Må i raps, rybs og sennep ikke anvendes senere end 28 dage før høst.

Farlig for bier - for at beskytte bier og andre bestøvende insekter må dette produkt

ikke anvendes i blomstrende afgrøder i biernes flyvetid fra kl. 03 til kl. 21.

Må ikke anvendes nærmere end 20 meter fra vandmiljøet (vandløb, søer mv.) for at

beskytte organismer, der lever i vand.

Undgå at forurene vandmiljøet med produktet eller med beholdere, der har inde-

holdt produktet. Rens ikke sprøjteudstyr nær overfladevand.

Opbevares utilgængeligt for børn.

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

FARLIG

FOR

BIER

CYTHRIN 500

FARLIG

FOR

BIER

FARLIG

FOR

BIER

Sundhedsskadelig

Miljøfarlig

Insektmiddel:

Må kun anvendes til bekæmpelse af insekter i hvede, rug, triticale, byg, havre, majs, raps, rybs, sennep, ærter, kartofler, bederoer, hovedsalat,

persille, dild, broccoli, blomkål, rosenkål, savojkål, hvidkål, rødkål, gulerod, knoldselleri, radise, skorzonerrod, peberrod, pastinak og persillerod.

Netto

indhold:

liter

CA603153-04/13 - Proof 1

27903/1/132730

27/03/2013

CA603153-04/13

CA603153-04/13 - Proof 1

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27/03/2013

Brugsanvisning:

Afgrøde(r)

Hvede, rug, triticale, byg, havre

Majs

Raps, ryps, sennep

Raps, ryps, sennep

Ærter

Ærter

Kartofler

Bederoer

Bederoer

Hovedsalat, persille, dild, broccoli,

blomkål, rosenkål, savojkål, hvidkål

og rødkål

Hovedsalat, persille, dild, broccoli,

blomkål, rosenkål, savojkål, hvidkål

og rødkål

Gulerod, knoldselleri, radis, skorzoner-

rod, peberrod, pastinak, persillerod

Skadegørere

Bladlus, kornbladbiller, trips, fritfluer

Alm. fritflue, bladlus

Jordlopper, kåltrips, rapsjordloppe

Glimmerbøsser, skulpesnudebille,

skulpegalmyg, kålbladlus, kålmøl

Kåltrips, stribet bladrandbille

Ærtebladlus, ærtevikler

Knoporme (agerugle), bladlus, bladtæger,

Coloradobiller

Bedeflue, bedejordloppe, kåltrips.

Ådselbille, agerugle, bedeugle, bladtæger

Jordlopper, kåltrips

Bladlus inkl. kålbladlus, lille og stor

kålsommerfugl, kålmøl

Agerugle

Dosis pr. ha.

50 ml

50 ml

40 ml

50 ml

40 ml

50 ml

50 ml

40 ml

50 ml

40 ml

50 ml

50 ml

Tidspunkt og antal sprøjtninger

Fra BBCH 10 og indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Indtil BBCH 67. Maksimalt 1 behandling pr. vækstsæson.

BBCH 10-73. Maksimalt 1 behandling pr. vækstsæson.

BBCH 10-73

Maksimalt 1 behandling pr. vækstsæson. Der er på mange lokaliteter konstateret nedsat

eller manglende virkning af pyrethroider mod glimmerbøsser pga. resistens. Her vil virk-

ningen af Cythrin 500 EC og andre pyrethroider være utilstrækkelig og der bør anvendes et

middel med anden virkningsmekanisme.

Indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Vandmængde 200-400 l/ha.

Indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Vandmængde 200-400 l/ha.

Indtil behandlingsfrist. Maksimalt 1 behandling pr. vækstsæson.

Vandmængde 200-400 l/ha.

CA603153-04/13 - Proof 1

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Sprøjteteknik:

Udbringning af Cythrin 500 skal ske på en sådan måde, at afdrift til omgivelserne undgås. Der

skal altid vælges en passende bomhøjde over behandlingspunktet så der kan ske en jævn

fordeling på afgrøde eller behandlingsflade. Overlapning i marken samt spild uden for området

skal begrænses til et minimum. Vandmængden bør altid tilpasses opgaven, men en mængde på

100-200 l vand pr. ha vil i de fleste tilfælde være passende. Den laveste vandmængde vælges,

hvor bladmassen er relativt lille og planterne er let våde af dug. Højeste vandmængde ved en tæt

afgrøde med en stor bladmasse eller under tørre vejr forhold.

Vindhastigheden skal altid være lav (< 4 m/s) på behandlingstidspunktet. Eventuelt bør der, hvor

det er muligt, vælges low-drift dyser, for yderligere at reducere risikoen for afdrift. Valg af dyse

tilpasses opgaven og der findes en lang række fabrikater på markedet, der opfylder gældende

regler. Nedenstående angiver eksempler på mulige dyser:

3 bar tryk og 6,5 km/t

Ydelse (l/min)

Væskemængde, liter pr ha

ISO fladsprededyse 0,15

ISO fladsprededyse 0,2

Low-drift dyser med samme kode har samme ydelse som tilsvarende fladsprededyse, men vær

opmærksom på, at de har en mindre andel af små dråber.

Virkningsmekanisme:

Cythrin 500 er et pyrethroid med kontaktvirkning mod de fleste insekter. Cythrin 500 optages i

planternes vokslag og er regnfast hurtigt efter udsprøjtning. Aktivstoffet påvirker skadedyrenes

nervesystem og medfører lammelse. Sprøjt kun under optimale forhold (vindstille) og når tempe-

raturen er mellem 5-25° C (bedst virkning mellem 10-25 °C).

Resistens:

CYTHRIN 500 tilhører gruppen af pyrethroider, IRAC gruppe 3A.

Der er på mange lokaliteter konstateret nedsat eller manglende virkning af pyrethroider mod glim-

merbøsser pga. resistens. Her vil virkningen af Cythrin 500 og andre pyrethroider være utilstræk-

kelig og der bør anvendes et middel med anden virkningsmekanisme.

Rengøring:

Rengøring af sprøjteudstyr efter CYTHRIN 500

1. Umiddelbart efter endt sprøjtning skylles sprøjten med rent vand, f.eks. fra rentvandsbeholde-

ren. Skyllevandet kan evt. sprøjtes over den afgrøde, der lige er sprøjtet. Husk også at rengøre

udstyret udvendig. Under rengøringen aktiveres alle ventiler/haner, så alle slanger bliver rengjort.

Endvidere skal sprøjten tømmes helt mellem hver skylning/vask.

2. Fyld sprøjten med vand tilsat 0,5 l. All Clear Extra pr. 100 l. vand, skyl slanger/bom, fyld efter i

tanken med vand og lad stå i mindst 15 min. med omrøring i gang. Tøm sprøjten gennem bom/

dyser. Skyl tank/bom med rent vand.

3. Dyser og sier rengøres separat med samme middel og koncentration, som er anvendt til sprøjten.

4. Gentag trin 2.

5. Skyl tank/sprøjte grundigt i 5 min. samtidig med, at skyllevandet sprøjtes ud gennem bom/dyser.

Der henvises i øvrigt til Miljøministeriets BEK nr. 268 af 31/03/2009 om påfyldning og vask m.v. af

sprøjter samt EU direktiv 2009/127/EF af 21. oktober 2009 om pesticidudbringningsmaskiner.

Tom emballage og rester af produktet:

Rester skal afleveres til den kommunale affaldsordning for farligt affald.

Tomme beholdere kan bortskaffes med dagrenovationen. Den tomme beholder bør skylles inden

bortskaffelse. Skyllevandet hældes op i sprøjtevæsken. Emballagen må ikke genbruges.

CA603153-04/13 - Proof 1

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Førstehjælp:

Generelle anvisninger:

Undgå berøring med hud, øjne og beklædning. Tilsmudset tøj tages straks af. Ved besvær: Gå til

lægen. Emballage, label og/eller sikkerhedsdatablad skal forevises lægen.

Indånding:

Ro, frisk luft, lægehjælp. Hvis vejrtrækning er besværlig gives ilt.

Hudkontakt:

Kommer stoffet på huden vaskes straks med store mængder vand. Ved irritation – søg læge

Øjenkontakt:

Skyl straks grundigt i mindst 15 minutter under rindende vand med åbne øjne, kontakt øjenlæge.

Indtagelse:

Skyl straks mund og drik rigeligt med vand, tilkald lægehjælp. Fremkald ikke opkastning uden at

have fået besked derpå af giftkontrolcenter eller læge. Fremkald aldrig opkastning eller giv noget

oralt, hvis den tilskadekommende er uden bevidsthed eller har krampeanfald.

Anvisninger til lægen:

Behandling: Symptomatisk behandling (dekontamination, vitalfunktionen), kontakt Giftcentralen og

følg deres anvisninger.

Deklaration:

Insektmiddel nr. 361-14

Præparattype:

Midlet er et emulgerbart koncentrat.

Analyse:

Analyse: 500 g/l CYPERMETHRIN.

Cypermethrin: 47,46% w/w.

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og plantebeskyttelsesmid-

delforordningen 1107/2009.

Indeholder cypermethrin. Kan udløse allergisk reaktion.

Indhold:

1,0 liter

Producenten oplyser:

Producenten fralægger sig ethvert ansvar for produktets effekt, samt skader, herunder følgeska-

der, der er opstået gennem ikke forskriftsmæssig opbevaring og/eller anvendelse af produktet.

Batchnummer:

Se nummer trykt direkte på dunken.

Anvendes senest 2 år efter produktionsdatoen. Se dato trykt direkte på dunken.

Producent og godkendelsesindehaver:

Agriphar s.a.

26/1 Rue de Renory

B-4102 Ougrée, Belgien

CA603153-04/13 - Proof 1

27903/1/132730

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CA603153-04/13 - Proof 1

27903/1/132730

27/03/2013

ADVARSEL

For at nedsætte risikoen for mennesker og miljø skal brugsanvisningen følges nøje.

Farlig ved indånding (R20).

Irriterer huden (R38).

Meget giftig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i

vandmiljøet (R50/53).

Undgå indånding af aerosoltåger.

Brug af egnede beskyttelseshandsker.

Vask huden efter arbejdet.

Vær opmærksom på, at Arbejdstilsynet har regler for arbejde med og udsættelse for

plantebeskyttelsesmidler. Læs nærmere i det eventuelt lovpligtige sikkerhedsdatablad samt

i Arbejdstilsynets informationsmateriale om bekæmpelsesmidler.

Emballagen må ikke genbruges.

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre straf:

Må kun anvendes til bekæmpelse af insekter i hvede, rug, triticale, byg, havre, majs,

raps, rybs, sennep, ærter, kartofler, bederoer, hovedsalat, persille, dild, broccoli,

blomkål, rosenkål, savojkål, hvidkål, rødkål, gulerod, knoldselleri, radise, skorzoner-

rod, peberrod, pastinak og persillerod.

Må ikke anvendes mod andre skadevoldere og

ikke i højere doseringer end de i brugsanvisningen nævnte.

Må kun anvendes 1 gang årligt.

Må i kartofler, peberrod, persillerod, pastinak, skorzonerrod, knoldselleri, radise,

hovedsalat, persille, dild, broccoli, blomkål, rosenkål, savojkål, hvidkål og rødkål

ikke anvendes senere end 7 dage før høst.

Må i ærter m. bælg, ærter u. bælg og majs ikke anvendes senere end 14 dage før høst.

Må i korn ikke anvendes senere end 21 dage før høst.

Må i bederoer ikke anvendes senere end 14 dage før høst.

Må i raps, rybs og sennep ikke anvendes senere end 28 dage før høst.

Farlig for bier - for at beskytte bier og andre bestøvende insekter må dette produkt

ikke anvendes i blomstrende afgrøder i biernes flyvetid fra kl. 03 til kl. 21.

Må ikke anvendes nærmere end 20 meter fra vandmiljøet (vandløb, søer mv.) for at

beskytte organismer, der lever i vand.

Undgå at forurene vandmiljøet med produktet eller med beholdere, der har inde-

holdt produktet. Rens ikke sprøjteudstyr nær overfladevand.

Opbevares utilgængeligt for børn.

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

FARLIG

FOR

BIER

CYTHRIN 500

FARLIG

FOR

BIER

FARLIG

FOR

BIER

Sundhedsskadelig

Miljøfarlig

Insektmiddel:

Må kun anvendes til bekæmpelse af insekter i hvede, rug, triticale, byg, havre, majs, raps, rybs, sennep, ærter, kartofler, bederoer, hovedsalat,

persille, dild, broccoli, blomkål, rosenkål, savojkål, hvidkål, rødkål, gulerod, knoldselleri, radise, skorzonerrod, peberrod, pastinak og persillerod.

Netto

indhold:

liter

CA603153-04/13 - Proof 1

27903/1/132730

27/03/2013

CA603153-04/13 - Proof 1

27903/1/132730

27/03/2013

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Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if...

FDA - U.S. Food and Drug Administration

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

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

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

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Black Rhino 25000 contains hidden drug ingredient

Public Notification: Black Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Krazzy Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Platinum Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

10-7-2018

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

PrEP wordt binnen een onderzoekssetting voor een periode van vijf jaar verstrekt aan de hoogrisicogroep van mannen die seks hebben met mannen (MSM). Dat heeft minister Bruno Bruins (Medische Zorg) vandaag bekend gemaakt. Op basis van schattingen van het RIVM zullen ongeveer 6500 mannen hiervan gebruik gaan maken en kunnen hiermee  250 hiv-infecties per jaar worden voorkomen. Voor gebruikers gaat een eigen bijdrage gelden van maximaal 25%, dat komt overeen met ongeveer 12 euro per maand. Ook wordt hen gev...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

26-6-2018

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

The scuba diving regulators can restrict airflow at low tank pressures (below 500 psi), posing a drowning hazard to divers.

Health Canada

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

20-6-2018

Public Notification: Black Stallion 35000 contains hidden drug ingredient

Public Notification: Black Stallion 35000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Stallion 35000, 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

12-6-2018

Ashley Furniture Industries , Inc. recalls Signature Design by Ashley Amnon Floor Lamp

Ashley Furniture Industries , Inc. recalls Signature Design by Ashley Amnon Floor Lamp

The lamp has incorrect lightbulb wattage information printed on a label on the sockets of the lamp. The incorrect labels indicate that each socket can support 40 W bulbs, however the product is only rated for each socket supporting a 25 W bulb. The use of lightbulbs with the incorrect wattage could potentially melt the power-switch, posing a burn hazard.

Health Canada

21-5-2018

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

18-5-2018

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered ta...

FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

18-4-2018

ViaGro 500mg Male Enhancement capsules

ViaGro 500mg Male Enhancement capsules

Safety advisory

Therapeutic Goods Administration - Australia

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

25-9-2018

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

FDA - U.S. Food and Drug Administration

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

17-8-2018

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here:  https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

FDA - U.S. Food and Drug Administration

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety

7-6-2018

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

FDA - U.S. Food and Drug Administration

24-5-2018

Xarelto (Bayer AG)

Xarelto (Bayer AG)

Xarelto (Active substance: rivaroxaban) - Centralised - Renewal - Commission Decision (2018)3264 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/944/R/60

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety

3-5-2018

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Active substance: Clopidogrel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2776 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/975/T/60

Europe -DG Health and Food Safety