Aftovaxpur DOE

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063.

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI02AA04

INN (International Name):

inactivated vaccine against foot-and-mouth disease

Therapeutic group:

Pigs; Cattle; Sheep

Therapeutic area:

Immunologicals

Therapeutic indications:

Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.

Product summary:

Revision: 8

Authorization status:

Withdrawn

Authorization date:

2013-07-15

Patient Information leaflet

17
B. PACKAGE LEAFLET
Medicinal product no longer authorised
18
PACKAGE LEAFLET:
AFTOVAXPUR DOE EMULSION FOR INJECTION FOR CATTLE, SHEEP AND PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
69800 Saint Priest
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT
Each dose of 2 ml of emulsion contains:
ACTIVE SUBSTANCES:
Purified, inactivated foot-and-mouth disease virus strain antigens, at
least 6 PD
50
* per strain.
* PD
50
– 50% protective dose in cattle as described in Ph. Eur. monograph
0063.
The number and type of strains included in the final product will be
adapted to the current
epidemiological situation at the time of formulation of the final
product and will be shown on the
label.
ADJUVANT:
Liquid paraffin 537 mg.
White emulsion after shaking.
4.
INDICATIONS
Active immunisation of cattle, sheep and pigs from 2 weeks of age
against foot-and-mouth disease to
reduce clinical signs.
Onset of immunity:
Cattle and sheep: 7 days after vaccination.
Pigs: 4 weeks after vaccination.
Medicinal product no longer authorised
19
Duration of immunity: vaccination of cattle, sheep and pigs induced
the production of neutralising
antibodies that persisted for at least 6 months. In cattle, the
antibody levels measured were above
those shown to be protective.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Swellings (diameter of up to 12 cm in ruminants and 4 cm in pigs)
occurred very commonly in most
animals after administration of a dose of vaccine. These local
reactions normally resolve over a period
of four weeks post vaccination, but may persist for longer in a s

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml of emulsion contains:
ACTIVE SUBSTANCES:
Maximum three of the following purified, inactivated foot-and-mouth
disease virus strains:
O1 Manisa
.................................................................................................................................
≥ 6 PD
50
*
O1 BFS
.......................................................................................................................................
≥ 6 PD
50
*
O Taiwan 3/97
...........................................................................................................................
≥ 6 PD
50
*
A22 Iraq
.....................................................................................................................................
≥ 6 PD
50
*
A24 Cruzeiro
.............................................................................................................................
≥ 6 PD
50
*
A Turkey 14/98
.........................................................................................................................
≥ 6 PD
50
*
Asia 1 Shamir
.............................................................................................................................
≥ 6 PD
50
*
SAT2 Saudi Arabia
...................................................................................................................
≥ 6 PD
50
*
* PD
50
– 50% protective dose in cattle as described in Ph. Eur. monograph
0063.
The number and type of strains included in the final product will be
adapted to the current
epidemiological situation at the time of formulation of the final
product and will be shown on the
label.
ADJUVANT:
Liquid paraffin
.............................................................................................................................