Salmoporc lyophilisate and solvent for suspension for injection for pigs

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Salmonella typhimurium mutant, strain 421/125

から入手可能:

IDT Biologika GmbH

ATCコード:

QI09AE02

INN（国際名）:

Salmonella typhimurium mutant, strain 421/125

投薬量:

.

医薬品形態:

Lyophilisate and solvent for suspension for injection

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療領域:

salmonella

認証ステータス:

Authorised

承認日:

2019-04-18

製品の特徴

Health Products Regulatory Authority
14 September 2020
CRN009Y3X
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,
genetically-stable, double-attenuated
(histidine-adenine auxotrophic)
​
5 x 10
8
to 5 x 10
9
CFU*
* 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.
Health Products Regulatory Authority
14 September 2020
CRN009Y3X
Page 2 of 4
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 w