Advantage Vet. til hund
Primær information
- Handelsnavn:
- Advantage Vet. til hund 100 mg/ml kutanopløsning
- Aktiv bestanddel:
- Imidacloprid
- Tilgængelig fra:
- Bayer Animal Health GmbH
- ATC-kode:
- QP53AX17
- INN (International Name):
- Imidacloprid
- Dosering:
- 100 mg/ml
- Lægemiddelform:
- kutanopløsning
- Brugt til:
- Dyr
- Medicin typen:
- Allopatiske stof
Dokumenter
- for sundhedspersonale:
- Produktresumé
-
- for den brede offentlighed:
- 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 offentligheden.
Lokation
- Fås i:
-
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
- 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 offentligheden.
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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/xUH4a #GetAheadOfSepsis pic.twitter.com/7rut8Big03
FDA - U.S. Food and Drug Administration
10-8-2018
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
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
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
22-6-2018
Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors submitting an application via the current existing submission process until 19 Sept 2018
Europe - EMA - European Medicines Agency
28-5-2018
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