EQUIP ARTERVAC EMULSION FOR INJECTION FOR HORSES AND PONIES

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS

Disponibil de la:

Zoetis Ireland Limited

Codul ATC:

QI05AA07

INN (nume internaţional):

EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS

Forma farmaceutică:

Emulsion for Injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Equine - Food

Zonă Terapeutică:

equine arteritis virus

Indicații terapeutice:

Immunological - Inactivated vaccine

Statutul autorizaţiei:

Authorised

Data de autorizare:

2013-06-21

Caracteristicilor produsului

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