Salmoporc, Lyophilisate and Solvent for Suspension for Injection for Pigs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Salmonella typhimurium

Commercializzato da:

Ceva Animal Health Ltd

Codice ATC:

QI09AE02

INN (Nome Internazionale):

Salmonella typhimurium

Forma farmaceutica:

Lyophilisate and solvent for suspension for injection

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Pigs

Area terapeutica:

Live Bacterial Vaccine

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2019-04-18

Scheda tecnica

Unlimited Renewal: August 2023
AN: 01396/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Salmoporc, lyophilisate and solvent for suspension for injection for
pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml of the reconstituted vaccine) contains:
ACTIVE SUBSTANCE:
_Salmonella_ Typhimurium mutant, strain 421/125,
genetically-stable, double-attenuated
5 x 10
8
to 5 x 10
9
CFU*
(histidine-adenine auxotrophic)
* Colony Forming Units
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
White to yellow-brownish lyophilisate
Clear colourless solvent
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Subcutaneous use:
For active immunisation of sows and gilts to reduce excretion of
_Salmonella _
Typhimurium wild type strains during lactation.
Onset of immunity: two weeks after the second vaccination
Duration of immunity: 24 weeks after the second vaccination
Oral use:
For active immunisation of suckling and weaned piglets to reduce
bacterial
colonisation and excretion as well as clinical symptoms due to an
infection with
_Salmonella _Typhimurium.
Onset of immunity: two weeks after the second vaccination
Duration of immunity: 19 weeks after the second vaccination
Unlimited Renewal: August 2023
AN: 01396/2023
Page 2 of 6
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
The vaccine has not been tested in breeding boars.
Do not use antimicrobial agents against _Salmonella_ spp. five days
before and five
days after immunisation.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinated pigs may excrete the vaccine strain up to 20 days following
vaccination.
The vaccine may thus spread to susceptible pigs in contact with
vaccinated pigs.
During this time, pigs intended for slaughter should not come into
contact with
vaccinated pigs.
Special precautio