产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1
N
AME OF THE
V
ETERINARY
M
EDICINAL
P
RODUCT
M+PAC
ThoroVAX (in DK, SE, EE, LT, LV)
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOS ITION
ACTIVE INGREDIENTS:
Quantity per 1 ml volume :
_Mycoplasma hyopneumoniae,_ inactivated
1.47 RPU (*)
Light mineral oil
0.134 ml
Aluminium (as hydroxide)
1.0 mg
Thiomersal
0.10 mg
Excipients
qs 1ml
For full list of excipients, see section 6.1.
(*) Relative Unit defined against a reference vaccine
3
P
HARMACEUTICAL
F
ORM
Emulsion for injection.
[White liquid emulsion]
4
C
LINICAL
P
ARTICULARS
_ _
4.1
TARGET SPECIES
Pig (fattening pigs, from 7 days of age).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization of pigs in order to reduce frequency and severity of lung lesions caused
by _Mycoplasma hyopneumoniae. _
_ _
For vaccination with 2 doses of 1 ml given 2-4 weeks apart, protection has been demonstrated 35 days
post initial dose and the duration of immunity is at least 6 months. In field studies, only
seroconversion has been demonstrated in pigs receiving two 1 ml doses.
For vaccination with 1 dose of 2 ml, protection has been shown 24 days after vaccination and duration
of immunity is at least 6 months after vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
Piglets vaccinated from 7 days of age :
Under laboratory conditions, piglets from 4 weeks of age after administration of 2 doses of 1 ml at 2-4
weeks interval produced a protective immune resp
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