Porcilis Lawsonia ID Lyophilisate and Solvent for Emulsion for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Lawsonia intracellularis

Available from:

MSD Animal Health UK Limited

ATC code:

QI09AB18

INN (International Name):

Lawsonia intracellularis

Pharmaceutical form:

Lyophilisate and solvent for emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Inactivated Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2020-12-23

Summary of Product characteristics

Amended pages: October 2023
AN: 00866/2022 & 01204/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Amended pages: October 2023
AN: 00866/2022 & 01204/2023
Page 2 of 7
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.
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: