Zulvac SBV Suspension for Injection for Cattle

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: VMD (Veterinary Medicines Directorate)

Ingredjent attiv:

Schmallenberg virus

Disponibbli minn:

Zoetis UK Limited

Kodiċi ATC:

QI02AA

INN (Isem Internazzjonali):

Schmallenberg virus

L-istatus ta 'awtorizzazzjoni:

Expired

Karatteristiċi tal-prodott

Revised: May 2014
AN: 01421/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZULVAC SBV Suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT:
AMOUNT PER 2ML
DOSE
Inactivated Schmallenberg
Virus, strain BH80/11-4
RP ≥ 1.1*
ADJUVANT:
Aluminium hydroxide
Saponin
385.2 mg (4 mg
Al3+)
0.4 mg
EXCIPIENTS:
Thiomersal
0.2 mg
Gentamicin
≤ 66 µg
*
Relative potency (mice potency test) compared to a reference vaccine
that
was shown efficacious in the target animal species
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Off-white or pink liquid
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cattle
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle from 3.5 months of age to reduce
viremia*
associated with infection by Schmallenberg virus.
Onset of immunity:
31 days
Duration of immunity:
6 months
* Below the level of detection by the validated RT-PCR method at 3.6
log10
RNA copies/ml of cattle plasma
Efficacy of the vaccine has not been determined in pregnant cattle.
Page 1 of 4
Revised: May 2014
AN: 01421/2013
This is a Provisional Marketing Authorisation. A full set of
supporting efficacy
data is not available for this product.
4.3.
CONTRAINDICATIONS
None.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No information is available on the use of the vaccine in seropositive
animals
including those with maternally derived antibodies.
This vaccine has been evaluated for safety and efficacy in cattle. If
used in
other domestic and wild ruminant species that are considered at risk
of
infection, its use in these species should be undertaken with care and
it is
advisable to test the vaccine on a small number of animals prior to
mass
vaccination. The level of efficacy for other species may differ from
that observed
in cattle.
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Vaccinate only healthy animals.
Avoid stress in the animals before and af