ENZOVAX

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

CHLAMYDOPHILA ABORTUS LIVE ATTENUATED STRAIN TS 1B

Tilgjengelig fra:

Intervet Ireland Limited

ATC-kode:

QI04AE01

INN (International Name):

CHLAMYDOPHILA ABORTUS LIVE ATTENUATED STRAIN TS 1B

Dosering :

Unknown

Legemiddelform:

Lyophilisate for suspension for injection

Resept typen:

POM

Terapeutisk gruppe:

Ovine

Terapeutisk område:

Chlamydia vaccine

Indikasjoner:

Immunological - Live Vaccine

Autorisasjon status:

Authorised

Autorisasjon dato:

2002-11-15

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enzovax
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active substance_
_Per dose_
Live, attenuated strain ts1B _Chlamydophila abortus_
10
5.0
-10
6.9
IFU*
(* Inclusion-body forming units)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white to cream-coloured pellet.
Solvent: colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Susceptible female breeding sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of susceptible female breeding sheep to reduce abortion caused by _Chlamydophila abortus_
infection.
Challenge studies have demonstrated that protection against Enzootic abortion and excretion of _Chlamydophila abortus_
post-challenge is undiminished for at least three years post vaccination with Enzovax.
Field studies in endemically infected flocks maintaining a policy of vaccinating incoming ewes with Enzovax indicate
that enzootic abortion levels remain very low in ewes vaccinated 4 years previously.
4.3 CONTRAINDICATIONS
Do not vaccinate pregnant animals
Do not vaccinate animals less than 4 weeks before mating.
Do not vaccinate animals which are being treated with antibiotics, particularly tetracyclines.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/06/2014_
_CRN 7017130_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
_Chlamydophila abortus _is only one of the causes of abortion in sheep. If the abortion rate remains unchanged in flocks
which have been vaccinated with Enzovax it is recommended that veterinary advice is sought.
The epidemiology of abortion due to _Chlamydoph