Equip Rotavirus Emulsion for Injection for Horses
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
Equine Rotavirus 1 IU
Available from:
Fort Dodge Animal Health
ATC code:
QI05AA09
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Equine rotavirus vaccine
Therapeutic area:
Horses Females
Authorization date:
2011-12-21
Summary of Product characteristics
Revised: April 2012
AN: 01961/2011
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equip Rotavirus emulsion for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
Equine Rotavirus vaccine (inactivated).
QUANTITATIVE COMPOSITION
Active Substances:
Per 1 ml dose
Inactivated Equine Rotavirus H2 strain RP>1.0*
(7.4 x 10
6
to 7.4 x 10
7
FAID
50
)
*Product is blended based on pre-inactivation titre but the blended and
finished product must have a relative potency of at least 1.0.
Adjuvants:
Per 1 ml dose
SP Oil Adjuvant:
Pluronic L121
1mg
Squalane
2mg
Tween 80 (Polysorbate 80)
0.16mg
Phosphate Buffered Saline
to 0.05ml
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses (pregnant mares)
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
For vaccination of pregnant mares to provide passive transfer of
antibodies to foals to reduce the risk of diarrhoea caused by
Equine Rotavirus H2 serotype.
Mares are able to transfer the passive immunity to the foals 4
weeks after the third vaccination. Foals of the vaccinated mares
show an increase in antibodies against Equine
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