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1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac MycoFLEX suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Inactivated _Mycoplasma hyopneumoniae_, J Strain Isolate B-3745.
Each dose of 1 ml of inactivated vaccine contains:
ACTIVE SUBSTANCE:
_Mycoplasma hyopneumoniae_:
> 1 RP*
*Relative Potency (ELISA test) by comparison with a reference
vaccine.
ADJUVANT:
Carbomer: 1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear to slightly opalescent, pink to brown suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (fattening pigs or future breeders until first reproductive service).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 3 weeks of age to reduce lung lesions following infection with
_Mycoplasma hyopneumoniae_.
Onset of protection occurs by 2 weeks post vaccination and lasts for at least 26 weeks.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only healthy animals should be vaccinated.
In case of anaphylactic reactions, the administration of epinephrine is recommended.
3
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
None.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Adverse reactions are uncommon: transient swelling up to four centimetres in diameter, sometimes
associated with redness of the skin,
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