Frontect (til hunde 5-10 kg)

Primær information

  • Handelsnavn:
  • Frontect (til hunde 5-10 kg) 67,6+504,8 mg spot-on, opløsning
  • Dosering:
  • 67,6+504,8 mg
  • Lægemiddelform:
  • spot-on, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Frontect (til hunde 5-10 kg) 67,6+504,8 mg spot-on, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 52823
  • Sidste ændring:
  • 18-07-2018

Produktresumé

19. februar 2018

PRODUKTRESUMÉ

for

Frontect, spot-on, opløsning

0.

D.SP.NR.

28878

1.

VETERINÆRLÆGEMIDLETS NAVN

Frontect

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver pipette indeholder:

Aktive stoffer

Hjælpestoffer

Frontect spot-

on, opløsning

Indhold

pipette

(ml)

Fipronil

(mg)

Permethrin

(mg)

Butylhydroxytoluen

(E321) (mg)

Hund 2-5 kg

33,8

252,4

0,563

Hund 5-10 kg

67,6

504,8

1,125

Hund 10-20 kg

135,2

1009,6

2,250

Hund 20-40 kg

270,4

2019,2

4,500

Hund 40-60 kg

405,6

3028,8

6,750

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Spot-on, opløsning

Klar, farveløs til gulbrun opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hund

4.2

Terapeutiske indikationer

Behandling og forebyggelse af loppe- og/eller flåtangreb, hvor repellerende (anti-

blodsugende) virkning mod sandfluer, stikfluer og/eller myg er nødvendig.

52823_spc.docx

Side 1 af 7

Lopper

Behandling og forebyggelse af Ctenocephalides felis loppeangreb samt forebyggelse af

Ctenocephalides canis loppeangreb. En behandling forebygger nye loppeangreb i 4 uger.

Præparatet kan indgå som del af behandlingsstrategien for loppebetinget allergisk

dermatitis, hvor dette tidligere er diagnosticeret af en dyrlæge.

Flåter

Behandling og forebyggelse af flåtangreb (Dermacentor reticulatus, Ixodes ricinus,

Rhipicephalus sanguineus). En behandling dræber (Dermacentor reticulatus, Ixodes

ricinus, Rhipicephalus sanguineus) og repellerer (Ixodes ricinus, Rhipicephalus

sanguineus) flåter i 4 uger efter behandling, samt repellerer Dermacentor reticulatus fra 7

dage og op til 4 uger efter behandling.

Myg og sandfluer

Repellerer (anti-blodsugende virkning) sandfluer (Phlebotomus perniciosus) i 3 uger og

myg (Culex pipiens, Aedes albopictus) i 4 uger. Dræber sandfluer (Phlebotomus

perniciosus) og myg (Aedes albopictus) i 3 uger.

Stikfluer

Repellerer (anti-blodsugende virkning) og dræber stikfluer (Stomoxys calcitrans) i 5 uger.

4.3

Kontraindikationer

Må ikke anvendes til syge eller rekonvalescente dyr.

Præparatet er kun til hunde. Må ikke anvendes til katte eller kaniner, da dette kan forårsage

bivirkninger og muligvis dødsfald.

Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et

eller flere af hjælpestofferne (se også punkt 4.5 ”Særlige forsigtighedsregler for dyret”).

4.4

Særlige advarsler

Tilhæftning af enkelte flåter eller bid af enkelte myg eller sandfluer kan forekomme.

Derfor kan overførsel af patogener fra disse leddyr ikke helt udelukkes, hvis forholdene er

ugunstige. Enkelte flåter kan tilhæfte og give slip igen inden for de første 24 timer efter

infestation. Såfremt flåter er til stede allerede når præparatet påføres, vil alle flåter ikke

nødvendigvis dræbes inden for 48 timer efter behandling.

Præparatets virkning mod lopper påvirkes ikke selv om dyret af og til bliver vådt

(svømning, bad). Hunde skal dog ikke svømme eller vaskes med shampoo inden for 48

timer efter behandling. Undgå hyppig svømning eller shamponering af behandlede hunde,

da dette kan reducere præparatets virkningsvarighed.

For at mindske risikoen for nye loppeangreb anbefales det at behandle alle hunde i

husholdningen. Andre dyr i samme husholdning bør også behandles med et passende

præparat. For at reducere smittetrykket fra omgivelserne anbefales det, at omgivelserne

behandles med et passende middel, som virker mod voksne lopper og deres

udviklingsstadier.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Da der ikke foreligger specifikke studier, anbefales det, at man ikke anvender præparatet til

hunde, som er yngre end 8 uger eller som vejer under 2 kg.

Undgå at produktet kommer i kontakt med hundens øjne.

52823_spc.docx

Side 2 af 7

Vær omhyggelig med at påføre præparatet på et sted, hvor dyret ikke kan slikke det af, og

sørg for, at andre dyr ikke slikker på behandlingsstedet efter påføringen.

Præparatet kan fremkalde kramper hos katte, som kan være dødelige på grund af kattes

unikke fysiologi, der gør at de ikke kan metabolisere visse stoffer, heriblandt permethrin.

Ved utilsigtet hudeksponering vaskes katten med shampoo eller sæbe, og der søges hurtig

dyrlægehjælp. For at forhindre at katte eksponeres for præparatet, skal behandlede hunde

holdes adskilt fra katte, indtil påføringsstedet er tørt. Det er vigtigt at sørge for, at katte

ikke slikker på påføringsstedet på en hund, som er behandlet med dette præparat. Søg

straks dyrlægehjælp i tilfælde af denne type eksponering.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Præparatet kan forårsage hud- og øjenirritation, og det skal derfor undgås at præparatet

kommer i kontakt med hud og øjne. Pipetten skal ikke åbnes i nærheden eller i retning af

ansigtet. Skyl straks øjnene med rigeligt vand, hvis præparatet kommer i øjet, eller hvis

øjnene bliver irriterede under administrationen. Søg lægehjælp hvis øjenirritationen varer

ved. Vask straks huden med rigeligt vand og sæbe i tilfælde af hudeksponering, eller hvis

huden bliver irriteret under administrationen. Søg lægehjælp hvis hudirritationen varer ved

eller kommer igen.

Personer med kendt overfølsomhed over for fipronil og/eller permethrin skal undgå

kontakt med præparatet.

Præparatet er skadeligt, hvis det sluges. Undgå hånd-til-mund kontakt. Undgå at ryge, spise

eller drikke under påføringen. Vask hænder efter brug. Skyl munden hvis præparatet sluges

og søg læge, hvis du bliver utilpas.

Da hjælpestoffet N-methylpyrrolidon kan fremkalde føtotoxicitet og teratogenicitet efter

signifikant eksponering, skal gravide kvinder bruge beskyttelseshandsker for at undgå

kontakt med præparatet.

Behandlede dyr bør ikke håndteres, før påføringsstedet er tørt, og børn skal ikke gives lov

til at lege med behandlede dyr, før påføringsstedet er tørt. Det anbefales derfor, at man ikke

behandler dyr i løbet af dagen, men venter til tidligt på aftenen, og at nyligt behandlede dyr

ikke får lov at sove sammen med ejeren, især ikke med børn.

Opbevar pipetterne i original blisterpakning og bortskaf tomme pipetter på passende måde

straks efter anvendelsen for at forhindre yderligere adgang til dem.

Andre forsigtighedsregler

Præparatet kan være skadeligt for organismer, der lever i vand. Behandlede hunde skal

ikke gives lov til at bade i stillestående vand i 2 dage efter behandling.

4.6

Bivirkninger

Efter anvendelse er der i meget sjældne tilfælde set forbigående hudreaktioner på

påføringsstedet (misfarvning af huden, lokalt hårtab, kløe, rødmen) samt generel kløe og

hårtab. Udtalt savlen, reversible nervøse symptomer (øget følsomhed over for berøring,

hyperaktivitet, muskelrysten, depression, andre nervøse symptomer) eller opkastning er

ligeledes observeret efter anvendelse.

Hvis hunden slikker på påføringsstedet, kan der ses kraftig savlen og opkastning.

4.7

Drægtighed, diegivning eller æglægning

Laboratorieundersøgelser med fipronil eller permethrin har ikke afsløret teratogene

virkninger eller føtal toksicitet. Der er ikke udført undersøgelser af dette præparat hos

drægtige og diegivende dyr (se 4.5 ”Særlige forsigtighedsregler for dyret”).

52823_spc.docx

Side 3 af 7

N-methylpyrrolidon, et hjælpestof i veterinærpræparatet, har vist at være teratogent hos

laboratoriedyr efter gentagen eksponering ved høje doser.

Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-

benefit-forholdet.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Den anbefalede minimumsdosis er 6,76 mg fipronil/kg kropsvægt og 50,48 mg

permethrin/kg kropsvægt svarende til 0,1 ml spot-on opløsning pr. kg kropsvægt.

Brugen af præparatet skal baseres på en bekræftet infestation eller risiko for infestation

med lopper og/eller flåter, hvor repellerende (anti-blodsugende) virkning mod sandfluer

og/eller stikfluer og/eller myg også er nødvendig. Afhængig af ektoparasitforekomsten kan

gentaget behandling være indiceret. I sådanne tilfælde skal intervallet mellem to

behandlinger være mindst 4 uger.

Administrationsmåde

Vælg korrekt pipettestørrelse i henhold til hundens vægt. Til hunde over 60 kg anvendes

den kombination af to pipettestørrelser, som tilsammen passer bedst til kropsvægten.

Præparatet skal påføres på to steder, hvor hunden ikke kan slikke sig. Disse steder er lige

foran skulderbladene og i nakken midt mellem hoved og skulderblade.

Tag blisteret ud af pakningen og adskil 1 blister. Tag pipetten ud ved at klippe langs den

stiplede linie med en saks eller ved at rive folien af efter at have bøjet det markerede

hjørne. Hold pipetten lodret og væk fra ansigtet – den åbnes ved at klippe spidsen af med

en saks. Del pelsen i hundens nakke indtil huden er synlig. Placer pipettens spids på huden

og tryk på pipetten for at påføre ca. halvdelen af indholdet midt på nakken midt mellem

hoved og skulderblade. Gentag påføringen lige foran skulderbladene for at tømme pipetten.

Sørg for at præparatet påføres direkte på huden og ikke i pelsen for at opnå det bedste

resultat.

4.10

Overdosering

Sikkerheden er undersøgt hos raske voksne hunde med op til 5 gange den maksimale dosis

(behandlet op til 3 gange med månedlige intervaller), samt hos hvalpe (8-uger gamle

behandlet én gang). Kendte bivirkninger kan være lette neurologiske symptomer,

opkastning og diaré. Disse er forbigående og forsvinder normalt uden behandling i løbet af

1-2 dage.

Risikoen for bivirkninger (se punkt 4.6) kan forøges ved overdosering, derfor skal dyr altid

behandles med korrekt pipettestørrelse i henhold til deres kropsvægt.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: Ectoparasiticider til udvortes brug.

ATCvet-kode: QP 53 AX 65 (fipronil, kombination).

52823_spc.docx

Side 4 af 7

5.1

Farmakodynamiske egenskaber

Fipronil er et insekticid og acaricid hørende til phenylpyrazolfamilien. Fipronil og dets

metabolit fipronilsulfon virker ved at påvirke de ligand-styrede chloridkanaler, især de, der

styres af neurotransmitteren GABA (gamma-aminosmørsyre), såvel de desensibiliserende

(D) som de ikke-desensibiliserende (N) kanaler styret af glutamat (Glu, unikke invertebrat

ligand-styrede chloridkanaler), hvorved de blokerer den præ- og postsynaptiske overførsel

af chlorioner over cellemembraner. Dette resulterer i en ukontrolleret CNS-aktivitet med

deraf følgende drab af insekter og mider.

Permethrin tilhører type I klassen af pyrethroider. Pyrethroider er acaricider og insekticider

med repellerende virkning. Pyrethroider påvirker de elektrisk ladede natriumkanaler hos

hvirveldyr og hvirvelløse dyr. Pyrethroider er såkaldte "åben kanal-blokkere" som påvirker

natriumkanalen ved at forsinke både aktiverings- og inaktiveringsegenskaber og således

medføre hyperexcitabilitet og død hos parasitten. Permethrin i præparatet har

afskrækkende (anti-blodsugende) virkning mod sandfluer (> 80 % i 4 uger), myg og flåter.

I en eksperimentel undersøgelse havde præparatet hurtigere dræbende virkning på voksne

lopper end fipronil alene hhv. 7 og 14 dage efter behandling.

”Speed of kill”

Præparatet dræber nye lopper (C. canis, C. felis) inden for 6 timer fra 2 dage efter

behandling og i en hel måned. C. felis lopper, som allerede findes på hunden når

behandlingen påføres, dræbes inden for 24 timer. ”Speed of kill” på C. canis, som allerede

er til stede ved behandlingsstart, er ikke blevet evalueret.

Præparatet dræber nye flåter (R. sanguineus og I. ricinus) inden for 6 timer fra 2 dage efter

behandling og i en hel måned. Flåter (R. sanguineus, I. ricinus, D.reticulatus), som allerede

findes på hunden når behandlingen påføres, dræbes inden for 48 timer.

I en eksperimentel undersøgelse blev det vist, at præparatet indirekte reducerer risikoen for

overførsel af Babesia canis fra inficerede Dermacentor reticulatus flåter

fra 7 dage og op til

4 uger efter behandling. Derved reduceredes risikoen for babesiose hos de behandlede hunde i

denne undersøgelse.

I en eksperimentel undersøgelse blev det vist, at præparatet indirekte reducerer risikoen for

overførsel af Ehrlichia canis fra inficerede Rhipicephalus sanguineus flåter

fra 7 dage og

op til 4 uger efter behandling. Derved reduceredes risikoen for ehrlichiose hos de behandlede

hunde i denne undersøgelse.

Præparatets virkning med hensyn til at reducere overførsel af infektiøse agens efter naturlig

eksponering under feltforhold er imidlertid ikke undersøgt.

5.2

Farmakokinetiske egenskaber

Den farmakokinetiske profil af fipronil og permethrin i kombination blev undersøgt efter

udvortes påføring hos hund ved at måle koncentrationen i plasma og hår i 58 dage efter

behandling. Både permethrin og fipronil, sammen med hovedmetabolitten fipronilsulfon,

fordeles godt i hundens pels i løbet af den første dag efter påføringen. Koncentrationen af

fipronil, fipronilsulfon og permethrin i pelsen aftager over tid og kan påvises i minimum

58 dage efter påføringen.

Fipronil og permethrin virker topikalt ved kontakt med eksterne parasitter, og den lave

systemiske absorption af fipronil og permethrin er ikke relevant for den kliniske virkning.

Spot-on påføringen medførte ubetydelig systemisk absorption af permethrin med sporadisk

målbar koncentrationer af cis-permethrin mellem 11,4 ng/ml og 33,9 ng/ml observeret 5 til

48 timer efter behandling.

52823_spc.docx

Side 5 af 7

Gennemsnitlig maksimal plasmakoncentration (C

) på 30,1 ± 10,3 ng/ml fipronil og 58,5

± 20,7 ng/ml fipronilsulfon blev observeret mellem dag 2 og 5 (T

) efter påføring.

Fipronil plasmakoncentration aftager derefter med en gennemsnitlig halveringstid på 4,8 ±

1,4 dage.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

N-methylpyrrolidon

Butylhydroxytoluen (E321)

Triglycerider, middelkædelængde

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

Pipette à 0,5 ml (33,8+252,4 mg, til hund 2-5 kg)

2 år.

Pipette à 1 ml (67,6+504,8 mg, til hund 5-10 kg)

30 måneder.

Pipette á 2 ml (135,2+1009,6 mg, til hund 10-20 kg)

30 måneder.

Pipette á 4 ml (270,4+2019,2 mg, til hund 20-40 kg)

30 måneder.

Pipette á 6 ml (405,6+3028,8 mg, til hund 40-60 kg)

30 måneder.

6.4

Særlige opbevaringsforhold

Opbevares i den originale blisterpakning.

Må ikke opbevares over 25

°C.

6.5

Emballage

Primærpakningen er en varmeformet film af polyethylen-ethylenvinylalkohol-

polyethylen/polypropylen.

Sekundærpakningen består af et plast/aluminiumblister med plast/aluminiumbagside.

Plastblisterkort med 1 pipette indeholdende 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml.

Æske med 3 eller 6 pipetter (som hver indeholder 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml).

Kun én pipettestørrelse pr. æske.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

52823_spc.docx

Side 6 af 7

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Ikke anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale

retningslinjer.

Præparatet må ikke udledes i vandløb, da dette kan være farligt for fisk og andre

organismer i vandet.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Merial Norden A/S

Strødamvej 52

2100 København Ø

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

33,8+252,4 mg:

52822

67,6+504,8 mg:

52823

135,2+1009,6 mg: 52824

270,4+2019,2 mg: 52825

405,6+3028,8 mg: 52826

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

30. september 2014

10.

DATO FOR ÆNDRING AF TEKSTEN

19. februar 2018

11.

UDLEVERINGSBESTEMMELSE

52823_spc.docx

Side 7 af 7

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Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

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

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

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

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

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (...

FDA - U.S. Food and Drug Administration

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

10-10-2018

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twi

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twi

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!! pic.twitter.com/Mhx4LNoJCr

FDA - U.S. Food and Drug Administration

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

29-8-2018

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Active substance: dinotefuran, pyriproxyfen, permethrin) - Centralised - Renewal - Commission Decision (2018)5783 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2555/R/9

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2069 (Professor Marjukka MyllArniemi)

EU/3/18/2069 (Professor Marjukka MyllArniemi)

EU/3/18/2069 (Active substance: Tilorone) - Orphan designation - Commission Decision (2018)5738 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/18

Europe -DG Health and Food Safety

22-8-2018

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed.  https://go.usa.gov/xUH4

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed. https://go.usa.gov/xUH4

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed. https://go.usa.gov/xUH4a  #GetAheadOfSepsis pic.twitter.com/7rut8Big03

FDA - U.S. Food and Drug Administration

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration