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

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Lawsonia intracellularis

Dostupno od:

MSD Animal Health UK Limited

INN (International ime):

Lawsonia intracellularis

Farmaceutski oblik:

Lyophilisate and solvent for emulsion for injection

Tip recepta:

POM-V - Prescription Only Medicine – Veterinarian

Terapijska grupa:

Pigs

Područje terapije:

Inactivated Bacterial Vaccine

Status autorizacije:

Authorized

Datum autorizacije:

2020-12-23

Svojstava lijeka

Issued: December 2020
AN: 01307/2019
Page 1 of 6
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:
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.
Issued: December 2020
AN: 01307/2019
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 4.9.
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