Salmoporc lyophilisate and solvent for suspension for injection for pigs

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Salmonella typhimurium mutant, strain 421/125

Commercializzato da:

Ceva Santé Animale

Codice ATC:

QI09AE02

INN (Nome Internazionale):

Salmonella typhimurium mutant, strain 421/125

Dosaggio:

.

Forma farmaceutica:

Lyophilisate and solvent for suspension for injection

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapeutica:

salmonella

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2019-04-18

Scheda tecnica

Health Products Regulatory Authority
08 December 2020
CRN009Z2L
Page 1 of 4
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, ​
5 x 10
8
to 5 x 10
9
CFU*
genetically-stable, double-attenuated
(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
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.
Health Products Regulatory Authority
08 December 2020
CRN009Z2L
Page 2 of 4
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
va