Salmoporc lyophilisate for oral suspension 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 for oral suspension

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 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
(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 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.
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.
Health Products Regulatory Authority
14 September 2020
CRN009Y3X
Page 2 of 4
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 han