Enzovax

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Chlamydophila abortus

Dostupné z:

MSD Animal Health UK Limited

ATC kód:

QI04AE01

INN (Medzinárodný Name):

Chlamydophila abortus

Forma lieku:

Lyophilisate for suspension for injection

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Sheep

Terapeutické oblasti:

Live Bacterial Vaccine

Stav Autorizácia:

Authorized

Dátum Autorizácia:

1996-04-26

Súhrn charakteristických

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AN: 01623/2021
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enzovax
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active substance_
per dose
Live, attenuated strain ts 1B _Chlamydophila abortus_
10
5.0
-10
6.9
IFU*
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
Amended pages: February 2022
AN: 01623/2021
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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