Aftopur AlSap

Summary of Product characteristics

                                Revised: January 2019
AN: 01033/2018
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AFTOPUR AlSap
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Purified inactivated Foot and Mouth disease virus antigen
Between one and four strains per dose
Up to 15µg 146S antigen per strain to ensure a potency of at least 3
PD
50
.
Adjuvant(s):
Aluminium hydroxide
5.0 - 7.5 mg
Purified Saponin
90 HU
Excipient(s):
Chloroform, at most 6 mg/ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Homogenous milky white aqueous suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Ruminants.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of ruminants to reduce clinical signs and
mortality
associated with Foot-and-Mouth Disease.
The onset of immunity is 3 weeks (demonstrated by challenge). Immunity
lasts 6
months (see section 4.9 for recommended vaccination program).
4.3
CONTRAINDICATIONS
Do not use in unhealthy animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: January 2019
AN: 01033/2018
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
None.
(ii)
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
None.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vaccination may be followed by a small local swelling and/or slight
pyrexia of short
duration. The maximum local swelling occurs 48 hours after vaccination
and covers
at an extreme an average area of 24 cm
2
. In nearly all animals the local swelling
had disappeared within one month after vaccination.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
This has not been studied under controlled laboratory conditions, but
experience in
the field suggests that vaccination of pregnant animals is safe.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No information is available on the safety and efficacy of this vaccine
when used with
a
                                
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