Porcilis Lawsonia Lyophilisate and Solvent for Emulsion for Injection for Pigs

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Lawsonia intracellularis

Beschikbaar vanaf:

MSD Animal Health UK Limited

INN (Algemene Internationale Benaming):

Lawsonia intracellularis

farmaceutische vorm:

Lyophilisate and solvent for emulsion for injection

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Pigs

Therapeutisch gebied:

Inactivated Bacterial Vaccine

Autorisatie-status:

Authorized

Autorisatie datum:

2019-11-04

Productkenmerken

Amended Pages: February 2022
AN: 01165/2021 & 01166/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Lawsonia lyophilisate and solvent for emulsion for injection
for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 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):
Light mineral oil
222.4 mg
Aluminium (as hydroxide)
2.0 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for emulsion for injection.
Lyophilisate: white/nearly white pellet/powder.
Solvent: homogenous white to nearly white emulsion after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE 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.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Amended Pages: February 2022
AN: 01165/2021 & 01166/2021
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injection/self-
injection may result in severe pain and swelling, particularly if
injected into a joint or
finger, and in rare cases could result in the loss of the affected
finger if prompt
medical attention is not given. If you are accidentally injected with
this veterinary
medicinal product, seek prompt medical advice even if only a very
small amount is
injected a