Porcilis Lawsonia ID lyophilisate and solvent for emulsion for injection for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lawsonia intracellularis strain spah-08 inactivated

Available from:

Intervet Ireland Limited

ATC code:

QI09AB

INN (International Name):

Lawsonia intracellularis strain spah-08 inactivated

Dosage:

.

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

Authorization status:

Authorised

Authorization date:

2021-01-08

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
PORCILIS LAWSONIA ID– PRODUCT INFORMATION
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Lawsonia ID lyophilisate and solvent for emulsion for
injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.2 ml reconstituted vaccine contains:
ACTIVE SUBSTANCE (LYOPHILISATE):
Inactivated
_ Lawsonia intracellularis _
strain SPAH-08
≥
5323 U
1
1
Antigenic mass units as determined in the
_in vitro_
potency test (ELISA).
ADJUVANT (SOLVENT):
Paraffin, light liquid 8.3 mg
Dl-α-tocopheryl acetate 0.6 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _
LYOPHILISATE:_ _
Sodium chloride
_ _
Potassium chloride
_ _
Disodium phosphate dihydrate
_ _
Potassium dihydrogen phosphate
_ _
Water for injections
_ _
SOLVENT:
Polysorbate 80
Simeticone
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Lyophilisate: white/nearly white pellet/powder.
Solvent: homogenous white to nearly white emulsion after shaking.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the active immunisation of pigs from 3 weeks of age to reduce
diarrhoea, loss of daily weight gain,
intestinal lesions, bacterial shedding and mortality caused by
_Lawsonia intracellularis _
infection.
PORCILIS LAWSONIA ID– PRODUCT INFORMATION
_ _
Onset of immunity: 4 weeks after vaccination.
Duration of immunity: 21 weeks after vaccination.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
This vaccine is intended for intradermal administration only.
The lyophilisate must be reconstituted in the dedicated “Solvent for
Porcilis Lawsonia ID” or in
Porcilis PCV ID following the instructions given in section 3.9.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
To the user:
This veterin