EQUIP ARTERVAC EMULSION FOR INJECTION FOR HORSES AND PONIES

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS

Disponível em:

Zoetis Ireland Limited

Código ATC:

QI05AA07

DCI (Denominação Comum Internacional):

EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS

Forma farmacêutica:

Emulsion for Injection

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Equine - Food

Área terapêutica:

equine arteritis virus

Indicações terapêuticas:

Immunological - Inactivated vaccine

Status de autorização:

Authorised

Data de autorização:

2013-06-21

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equip Artervac emulsion for injection for horses and ponies.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses and ponies from the age of 9 months.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of horses and ponies against equine
arteritis in order to reduce clinical signs and shedding
of virus in nasal secretion after infection.
Onset of immunity:
3 weeks post primary vaccination
Duration of immunity: 6 months
4.3 CONTRAINDICATIONS
Do not use in sick animals.
Each dose of 1 ml contains :
ACTIVE SUBSTANCE
Inactivated Equine Arteritis Vaccine, Bucyrus strain
RP*=1.0-1.8
* Relative Potency compared to a reference vaccine
ADJUVANT
Squalane*
1.61 mg
*As component of MetaStim (that also contains Pluronic L-121 and
Polysorbate 80)
EXCIPIENT
Eagles Hepes (0.05 % LAH) Medium
qs to 1.0 ml
For a full list of excipients, see section 6.1.
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccination does not prevent infection.
Vaccination does not have an effect on the shedding of EAV by
previously infected carrier stallions.
The effect of the vaccine on the fertility of breeding stallions has
not been investigated.
Under some national legisl