Advantage Vet. til hund

Primær information

  • Handelsnavn:
  • Advantage Vet. til hund 100 mg/ml kutanopløsning
  • Dosering:
  • 100 mg/ml
  • Lægemiddelform:
  • kutanopløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

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Lokation

  • Fås i:
  • Advantage Vet. til hund 100 mg/ml kutanopløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 18911
  • Sidste ændring:
  • 02-02-2018

Produktresumé

17. februar 2017

PRODUKTRESUMÉ

for

Advantage Vet. til hund, kutanopløsning

0.

D.SP.NR

9755

1.

VETERINÆRLÆGEMIDLETS NAVN

Advantage Vet. til hund

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder:

Aktivt stof:

Imidacloprid 100 mg.

Hjælpestoffer:

Butylhydroxytoluen (E321) 1 mg.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Kutanopløsning til hund.

Klar gul til svagt brun opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hund.

4.2

Terapeutiske indikationer

Til forebyggelse og behandling af loppeangreb, samt til behandling af pelslus (Trichodectes

canis) på hunde på under 4 kg, 4-10 kg, 10-25 kg og 25 kg eller derover.

Til hunde under 4 kg anvendes pipetter a 0,4 ml.

Til hunde mellem 4 og 10 kg anvendes pipetter a 1,0 ml.

Til hunde på mellem 10 og 25 kg anvendes pipetter a 2,5 ml.

Til hunde på 25 kg eller derover anvendes pipetter a 4 ml (se pkt. 4.9 ”Dosering og

indgivelsesmåde”).

18911_spc.doc

Side 1 af 6

Lopper på hunde dør indenfor 1 døgn efter behandling. En behandling forebygger yderligere

loppeangreb i 4 uger. Præparatet kan anvendes som en del af behandlingsstrategien til kontrol

af loppebetinget allergisk dermatitis (Flea Allergy Dermatits (FAD)), hvor diagnosen er stillet

af dyrlægen.

4.3

Kontraindikationer

Diende hvalpe under 8 uger behandles ikke.

Bør ikke anvendes til dyr med kendt overfølsomhed over for det aktive stof eller over for et

eller flere af hjælpestofferne.

4.4

Særlige advarsler for hver dyreart

Ingen.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Dette præparat er kun til udvortes brug og må ikke gives oralt.

Undgå at pipettens indhold kommer i kontakt med øjne eller mund hos dyret.

Tillad ikke nyligt behandlede dyr at slikke på hinanden.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Vask hænderne grundigt efter behandling af dyret.

Ved spild af præparatet på huden afvaskes denne med sæbe og vand.

Personer med kendt hudoverfølsomhed kan være særligt følsomme overfor dette præparat.

Undgå at øjne og mund kommer i kontakt med præparatet.

Hvis præparatet kommer i øjnene ved et uheld, gennemskylles de med vand. Søg lægehjælp

hvis hud- eller øjenirritationer varer ved, eller hvis præparatet ved et uheld sluges.

Spis, drik og ryg ikke under påføringen.

4.6

Bivirkninger

Præparatet smager bittert og spytsekretion kan lejlighedsvist fremkomme, hvis hunden

slikker på applikationsstedet umiddelbart efter behandling. Dette er ikke tegn på forgiftning

og forsvinder indenfor nogle minutter uden behandling (se pkt. 4.9 Dosering og

indgivelsesmåde”).

I meget sjældne tilfælde kan hudreaktioner så som hårtab, rødmen af huden, kløen og sår

opstå. Nervøsitet og desorientering kan også forekomme. Savlen og nervøse tegn så som

ataxi, tremor og depression har været observeret for hunde.

4.7

Drægtighed, diegivning eller æglægning

Der er ikke set fosterskader, teratogene eller reproduktive toksiske effekter i studier med

imidacloprid hos rotter og kaniner. Undersøgelser på drægtige og diegivende tæver samt

deres afkom er begrænsede. Indtil videre er der ikke tegn på bivirkninger hos disse dyr.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Der er ikke set interaktioner mellem dette produkt i den dobbelte rekommanderede dosis og

følgende almindelige anvendte veterinære præparater: fenthion, lufenuron, milbemycin,

febantel, pyrantel og praziquantel. Der er heller ikke set interaktioner i forbindelse med en

bred vifte af rutine behandlinger, herunder vaccinationer.

18911_spc.doc

Side 2 af 6

4.9

Dosering og indgivelsesmåde

Dosis og behandlingstabel:

Hund (kg lgm.)

Produkt

Antal pipetter

Imidacloprid

(mg/kg lgm.)

< 4 kg

Advantage Vet. til hunde

1 x 0.4 ml

minimum 10

≥ 4 < 10 kg

Advantage Vet. til hunde

1 x 1.0 ml

minimum 10

≥ 10 < 25 kg

Advantage Vet. til hunde

1 x 2.5 ml

minimum 10

≥ 25 < 40 kg

Advantage Vet. til hunde

1 x 4.0 ml

minimum 10

≥ 40 kg

Advantage Vet. til hunde

2 x 4.0 ml

minimum 10

Reinfestation af nye lopper fra omgivelser kan fortsætte i 6 uger eller længere efter

startbehandlingen. Mere end en behandling kan derfor være nødvendig i tilfælde, hvor antallet

af lopper i omgivelserne er stort. For at reducere reinfestation fra omgivelserne anbefales det i

tillæg til behandling at bruge et egnet bekæmpelsesmiddel mod voksne lopper og deres

udviklingsstadier.

Præparatet forbliver effektivt, også selv om dyret bliver vådt, f.eks. efter svømning eller heftig

regn. Imidlertid kan genbehandling blive nødvendig tidligere end 4 uger ved hyppig

svømning eller vask, afhængig af forekomsten af lopper i omgivelserne. Der må dog ikke

genbehandles oftere end 1 gang om ugen.

I tilfælde af infestation med pelslus, anbefales en yderligere dyrlægeundersøgelse 30 dage

efter behandling, da nogle dyr kræver en 2. behandling.

Administrationsmåde:

Tag 1 pipette ud af pakningen. Til hunde på 40 kg eller derover bruges 2 x 4.0 ml pipetter.

Hold pipetten opret, drej og træk hætten af. Vend hætten og sæt den på pipetten. Drej rundt

og træk hætten af igen for derved at bryde forseglingen.

Hunde under 25 kg:

Med hunden i stående stilling deles pelsen mellem skulderbladene indtil huden er synlig.

Placér spidsen af pipetten på huden og tryk fast adskillige gange for at tømme indholdet ud

direkte på huden.

18911_spc.doc

Side 3 af 6

Hunde på 25 kg og derover

Hunden skal stå op under påføringen. Pipettens indhold påføres 3 eller 4 steder på ryggen fra

skulderblad til halerod. På hvert påføringssted deles pelsen indtil huden er synlig.

Placér spidsen af pipetten på huden og tryk en del af indholdet ud direkte på huden.

For alle hunde:

Påfør præparatet i tilpas mængde ad gangen, og undgå overskud der kan løbe ned ad siden på

hunden.

Præparatet smager bittert og spytsekretion kan lejlighedsvist forekomme, hvis hunden slikker

på applikationsstedet umiddelbart efter behandling. Dette er ikke tegn på forgiftning og

forsvinder indenfor nogle minutter uden behandling. Korrekt applikation minimerer hundens

mulighed for at slikke præparatet i sig.

Anvend kun præparatet på uskadt hud. Lad ikke dyr, der lige er behandlet, slikke på hinanden.

4.10

Overdosering

Ingen kliniske bivirkninger blev bemærket, hverken efter brug af individuelle doser på op til

200 mg/kg legemsvægt (5-8 gange terapeutisk dosis) eller ved daglig behandling med 100

mg/kg legemsvægt i 5 på hinanden følgende dage, eller ved ugentlige behandlinger på 5

gange maximum dosis i 8 på hinanden følgende uger.

Ved overdosering, eller ved indtagelse ved at slikke på applikationsstedet, kan der i sjældne

tilfælde opstå forstyrrelser af nervesystemet (så som kramper, tremor, ataxi, mydriasis,

miosis, sløvhed).

Forgiftningstegn er usandsynlige hos dyr ved fejlagtig oral indtagelse af Advantage Vet.

Behandlingen bør være symptomatisk under opsyn af en dyrlæge. Ingen specifik antidot

kendes, men brug af aktiv kul kan lindre symptomerne.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE OG IMMUNOLOGISKE OPLYSNINGER

Farmakoterapeutisk gruppe: Antiparasitært middel

ATCvet-kode: QP 53 AX 17

18911_spc.doc

Side 4 af 6

5.1

Farmakodynamiske egenskaber

Imidacloprid

1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine

middel mod ektoparasitter tilhørende en ny gruppe af chloronicotinyl forbindelser. Kemisk

nærmere beskrevet som et chloronicotinyl nitroguanidin.

Imidacloprid binder sig med høj affinitet til nicotinerge acetylcholin receptorer i den

postsynaptiske del af centralnervesystemet (CNS). Den påfølgende hæmning af den

cholinerge transmission hos insekter resulterer i lammelse og død. På CNS hos pattedyr har

imidacloprid derimod praktisk taget ingen effekt pga. den svage affinitet til pattedyrs

nicotinerge receptorer og den postulerede svage penetration gennem blod/hjerne barrieren i

CNS. Den lave farmakologiske aktivitet hos pattedyr understøttes af safety-studier med

systemisk administration af subletale doser af imidacloprid til kaniner, mus og rotter.

I videregående undersøgelser har imidacloprid, udover effekt på voksne lopper, også vist

effekt på loppelarver i omgivelserne af det behandlede dyr. Larvestadier i dyrets omgivelser

dør efter kontakt med det behandlede dyr.

5.2

Farmakokinetiske egenskaber

Præparatet

beregnet

kutan

administration.

følge

anbefalede

administrationsmåde til hund, vil præparatet hurtigt fordeles ud over dyret.

Imidacloprids systemiske absorption er meget lav, forbigående og uden relevans for den

kliniske effekt, som vist ved overdoserings-studier og serumkinetik-studier på rotter og

målgruppe-dyrene. Dette er yderligere blevet vist i en undersøgelse, hvor lopper ikke blev

dræbt hos behandlede dyr, hvor det aktive stof var fjernet fra dyrets hud og pels.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Butylhydroxytoluen (E321)

Benzylalkohol

Propylenkarbonat

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

Opbevaringstid for veterinærlægemidlet i salgspakning: 5 år.

6.4

Særlige opbevaringsforhold

Der er ikke nogen særlige opbevaringsbetingelser.

Må ikke opbevares sammen med nærings- og nydelsesmidler samt foderstoffer.

6.5

Emballage

Pakninger med 1, 2, 3, 4 eller 6 enkeltdosis-pipetter a 0,4/1,0/2,5/4,0 ml

(40mg/100mg/250mg/400mg) imidacloprid).

Pipetterne samt hætter er af hvid polypropylen.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

CAS-No. 138261-41-3

18911_spc.doc

Side 5 af 6

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal destrueres i

overensstemmelse med de lokale krav.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Bayer Animal Health GmbH

D-51368 Leverkusen

Tyskland

Repræsentant

Bayer A/S

Animal Health

Arne Jacobsens Allé 13

2300 København S

8.

MARKEDSFØRINGSTILLADELSESNUMMER

0,4 ml (hunde under 4 kg):

18911

1,0 ml (hunde 4-10 kg):

38494

2,5 ml (hunde 10-25 kg):

38495

4 ml (hunde 25-40 kg):

30478

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

28. august 1997

10.

DATO FOR ÆNDRING AF TEKSTEN

17. februar 2017

11.

UDLEVERINGSBESTEMMELSE

18911_spc.doc

Side 6 af 6

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    Anmode informationsbrochure for offentligheden.



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The Reimbursement Committee's recommendation on the future reimbursement status of laxatives (ATC groups A06 and A02AA04) has been open for consultation until 27 May 2009.

Danish Medicines Agency

4-6-2009

Reimbursement status of medicinal products in ATC group A08, antiobesity preparations, excl. diet products: Consultation responses to the Reimbursement Committee's recommendation

Reimbursement status of medicinal products in ATC group A08, antiobesity preparations, excl. diet products: Consultation responses to the Reimbursement Committee's recommendation

The Reimbursement Committee's recommendation on the future reimbursement status of antiobesity preparations, excl. diet products (ATC group A08) has been open for consultation until 25 May 2009.

Danish Medicines Agency

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

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

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

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

Europe - EMA - European Medicines Agency

28-5-2018

Seresto and its associated name Foresto

Seresto and its associated name Foresto

Seresto and its associated name Foresto (Active substance: imidacloprid/flumethrin) - Community Referrals - Art 13 - Commission Decision (2018)3404 of Mon, 28 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/A/125

Europe -DG Health and Food Safety