Footvax Emulsion for Injection for Sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dichelobacter nodosus serotype I; Dichelobacter nodosus serotype H; Dichelobacter nodosus serotype G; Dichelobacter nodosusserotype F ; Dichelobacter nodosus serotype E; Dichelobacter nodosus serotype D ; Dichelobacter nodosus serotype C ; Dichelobacter nodosus serotype B2; Dichelobacter nodosus serotype B1; Dichelobacter nodosus serotype A

Available from:

Intervet Ireland Limited

ATC code:

QI04AB03

INN (International Name):

Dichelobacter nodosus serotype I; Dichelobacter nodosus serotype H; Dichelobacter nodosus serotype G; Dichelobacter nodosusserotype F ; Dichelobacter nodosus serotype E; Dichelobacter nodosus serotype D ; Dichelobacter nodosus serotype C ; Dichelobacter nodosus serotype B2; Dichelobacter nodosus serotype B1; Dichelobacter nodosus serotype A

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Sheep

Therapeutic area:

bacteroides

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Authorised

Authorization date:

2004-02-20

Summary of Product characteristics

Health Products Regulatory Authority
18 August 2021
CRN00C9YH
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Footvax Emulsion for Injection for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains:
ACTIVE SUBSTANCES:
_Dichelobacter nodosus _serotype A
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype B
1
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype B
2
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype C
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype D
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype E
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype F
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype G
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype H
10 μg pili equivalent to ≥400 potency units
*
_Dichelobacter nodosus _serotype I
5 x 10
8
cells/ml equivalent to ≥ 400 potency units
*
*
based on the potency test
​
​
ADJUVANTS:
Light mineral oil
60.0 % v/v
Mannide oleate
4.5 % v/v
​
​
EXCIPIENTS:
Preservative: thiomersal
0.015 % w/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep from 4 weeks of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of sheep against footrot caused by
_Dichelobacter nodosus_ for the purposes of reducing the risk of
a clinical infection due to _Dichelobacter nodosus. _
Onset of immunity: 3 weeks after the primary vaccination course.
Duration of immunity: 6 months.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Do not vaccinate sheep within 6 - 8 weeks of shearing.
Health Products Regulatory Authority
18 August 2021
CRN00C9YH
Page 2 of 4
Sheep destined for show or s