Program Vet.

Primær information

  • Handelsnavn:
  • Program Vet. 40 mg injektionsvæske, suspension
  • Dosering:
  • 40 mg
  • Lægemiddelform:
  • injektionsvæske, suspension
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • 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:
  • Program Vet. 40 mg injektionsvæske, suspension
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 30014
  • Sidste ændring:
  • 22-02-2018

Produktresumé

3. oktober 2016

PRODUKTRESUMÉ

for

Program Vet., injektionsvæske, suspension, fyldt engangssprøjte

0.

D.SP.NR

8735

1.

VETERINÆRLÆGEMIDLETS NAVN

Program Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Lægemiddelstof: Lufenuron 40 mg per injektionssprøjte (0,4 ml af en 10% suspension)

Alle hjælpestoffer, se pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, suspension, fyldt engangssprøjte, s.c.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Katte der vejer under 4 kg og fravænnede killinger.

4.2

Terapeutiske indikationer

Program Vet. injektionsvæske er beregnet til forebyggelse af loppeformering hos kat, ved at

hæmme udviklingen af loppeæg til voksne lopper i 6 måneder. Produktet virker på loppens

æg og larvestadier. Effektive blodkoncentrationer af lufenuron opnås indenfor 21 dage.

4.3

Kontraindikationer

Må ikke bruges til hunde. Hjælpestoffet Polyvinylpyrrolidon (Povidon) er et potent

histaminudløsende stof hos hund. En alvorlig reaktion, som ikke ses hos kat, kan forekomme

hos hund.

4.4

Særlige advarsler

Ingen.

4.5

Særlige forsigtighedsregler vedrørende brugen

Injektionen bør foretages under aseptiske betingelser.

30014_spc.doc

Side 1 af 4

Særlige forsigtighedsregler for dyret

Reaktion på injektionsstedet kan forkomme hos nogle katte, i form af en lille smertefri

hævelse på injektionsstedet, som almindeligvis forsvinder indenfor 6 uger efter

administrationen.

Hvis katten har en loppeinfestation fra starten af behandlingen, anbefales det at anvende et

loppe adulticid. Det er vigtigt at alle katte (undtagen ikke fravænnede killinger) i en husstand

behandles med Program Vet. for at stoppe loppeinfestationen. Hunde i den samme

husholdning bør behandles som anbefalet af dyrlægen.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

I tilfælde af selv-inokulering kan en lokal reaktion forekomme. Søg læge ved sådanne

omstændigheder.

Andre forsigtighedsregler

Ingen

4.6

Bivirkninger

Program Vet. injektionsvæske tåles godt af alle katte, men kan forårsage smerte ved

injektionen. Det kan forårsage en forbigående mild og smertefri reaktion på

injektionsstedet. I sjældne tilfælde kan der opstå sløvhed og anorexi i få timer efter

injektionen, hvilket hurtigt forsvinder.

4.7

Drægtighed, diegivning eller æglægning

Der kan ikke forventes skadelige effekter når produktet gives under drægtighed og laktation.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Den anbefalede dosis er 10 mg lufenuron per kg legemsvægt, når det administreres

parenteralt.

Kattens vægt i kg

mindre end 4

Dosis

1 Program Vet. 40 mg

injektionssprøjte

For at opnå fuld effektivitet af produktet, skal hele engangssprøjtens indhold injiceres

subkutant, for eksempel dorsalt foran skulderbladene.

Engangssprøjten skal rystes kraftigt for at rekonstituere suspensionen, og herefter skal

injektionen straks foretages.

4.10

Overdosering

I en undersøgelse hvor Program Vet. injektionsvæske blev givet til kat i 5 gange den

anbefalede dosis, 3 gange med 2 måneders interval, var den eneste bivirkning en forbigående

inflammatorisk reaktion på injektionsstedet.

4.11

Tilbageholdelsestid

Ikke relevant.

30014_spc.doc

Side 2 af 4

5.

FARMAKOLOGISKE EGENSKABER

Det aktive stof, lufenuron, er en insekt udviklingshæmmer (insect development inhibitor,

IDI), som hører til den kemiske klasse benzoylurea.

Farmakoterapeutisk

gruppe:

Antiparasitære

midler,

insekticider

repellenter,

ektoparasiticider til systemisk brug, kitinsynteseinhibitorer.

ATCvet kode: QP 53 BC 01

5.1

Farmakodynamiske egenskaber

Lufenuron (INN) hæmmer syntesen og deponeringen af kitin. Når det administreres systemisk

til dyret, vil lopper der infesterer katten indtage det aktive stof med deres blodmåltid og

overføre det til deres æg. Som en konsekvens heraf blokeres dannelsen af larvale

kitinstrukturer, en proces der er essentiel for insekter og udviklingen af levedygtigt afkom.

5.2

Farmakokinetiske egenskaber

Efter subkutan administration af produktet absorberes det aktive stof fra et lille depot på

injektionsstedet og deponeres fortrinsvis i fedtvævet, hvorfra det til stadighed frigives

umetaboliseret til blodet. Effektive blodkoncentrationer af lufenuron opnås indenfor 21 dage

efter den første injektion, og den lave eliminationshastighed sikrer en effektiv koncentration

af det aktive stof i blodet (over 50-100 ppb) i mindst 6 måneder.

5.3

Miljømæssige forhold

Ingen kendte.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Polysorbat 21

Povidon 12

Natriumchlorid

Vand til injektionsvæsker

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

5 år.

Engangssprøjten må ikke genbruges.

6.4

Særlige opbevaringsforhold

Må ikke opbevares frossen.

Opbevares i original emballage/beholder.

6.5

Emballage

Program Vet. injektionsvæske findes i fyldte engangssprøjter, 1 ml Dupharject glas

injektionssprøjter, indeholdende 0,4 ml af en steril hvid til gul vandig injektionssuspension.

Ingangssprøjterne er klar til brug og er påsat en kanyle i rustfrit stål (gauge 25; 0,5 x 16 mm).

30014_spc.doc

Side 3 af 4

Engangssprøjterne er pakket enkeltvis i pakker af 10 stk.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Beholder og eventuelt restindhold tilbageleveres til apotek/leverandør eller til kommunal

modtageordning.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Elanco Europe Ltd

Lilly House, Priestley Road

Basingstoke RG 24 9NL

Storbritannien

Repræsentant

Elanco Animal Health A/S

Lyskær 3E, 2. tv.

2730 Herlev

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

30014

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

2. juli 1998

10.

DATO FOR ÆNDRING AF TEKSTEN

3. oktober 2016

11.

UDLEVERINGSBESTEMMELSE

30014_spc.doc

Side 4 af 4

  • 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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ZO SKIN HEALTH ANTI-AGING PROGRAM (Titanium Dioxide) Kit [ZO Skin Health, Inc.]

Updated Date: Nov 7, 2017 EST

US - DailyMed

3-11-2017

ZO SKIN HEALTH DAILY SKINCARE PROGRAM (Titanium Dioxide) Kit [ZO Skin Health, Inc.]

ZO SKIN HEALTH DAILY SKINCARE PROGRAM (Titanium Dioxide) Kit [ZO Skin Health, Inc.]

Updated Date: Nov 3, 2017 EST

US - DailyMed

19-10-2017

TGA presentation: TGA Pharmacovigilance Inspection Program information sessions

TGA presentation: TGA Pharmacovigilance Inspection Program information sessions

Preparing for inspections, inspection process, and close out of inspections.

Therapeutic Goods Administration - Australia