Enzovax

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Chlamydophila abortus live attenuated strain ts 1b

זמין מ:

Intervet Ireland Limited

קוד ATC:

QI04AE01

INN (שם בינלאומי):

Chlamydophila abortus live attenuated strain ts 1b

כמות:

10^5 - 10^6.9 inclusion-body forming units

טופס פרצבטיות:

Lyophilisate and solvent for suspension for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Sheep

איזור תרפויטי:

chlamydia

סממני תרפויטית:

Immunological - Live Vaccine

מצב אישור:

Authorised

תאריך אישור:

2002-11-15

מאפייני מוצר

Health Products Regulatory Authority
15 January 2022
CRN00CRJG
Page 1 of 5
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.
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 _Chlamydophila abortus _in ewes
involves a long incubation period. Ewes that abort in any
lambing season have usually been infected at the previous lambing.
Field trial data indicate that vaccinating incubating ewes
will reduce the incidence of abortion, but a proportion can still go
on to abort.
Care should be taken in handling