EQUIP ARTERVAC EMULSION FOR INJECTION FOR HORSES AND PONIES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS
Available from:
Pfizer Healthcare Ireland
ATC code:
QI05AA07
Pharmaceutical form:
Emulsion for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Equine - Food
Authorization date:
2011-05-27
Summary of Product characteristics
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/04/2012_
_CRN 7012000_
_page number: 1_
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 legislation EVA is a notifiable disease (UK). Please refer to the national product literature for
recommendations on vaccination to comply with this legislation.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERIN
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