Salmoporc, Lyophilisate for Oral Suspension for Pigs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Salmonella typhimurium

Commercializzato da:

IDT BIOLOGIKA GMBH

Codice ATC:

QI09AE02

INN (Nome Internazionale):

Salmonella typhimurium

Forma farmaceutica:

Lyophilisate for Oral Suspension

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

Revised: October 2020
AN: 00911/2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Salmoporc, lyophilisate for oral suspension 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 for oral suspension
White to yellow-brownish lyophilisate
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
Page 1 of 5
Revised: October 2020
AN: 00911/2020
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
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 precautions to be taken by the person administering the
veterinary medicinal
product to animals
In case of ingestion and in case the vaccine comes into contact with a
mucous
membrane, seek medical advice immediately and show the package leaflet
or the
label to the physician.
Personal protective equipment consisting of disposable gloves should
be worn when
handling the veterinary medicinal product.
Since this vaccine has been p