Suiseng Diff/A Suspension for Injection for Pigs

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Clostridioides difficile, Clostridium perfringens

可用日期:

Laboratorios Hipra SA

ATC代码:

QI09AB12

INN（国际名称）:

Clostridioides difficile, Clostridium perfringens

药物剂型:

Suspension for injection

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Pigs

治疗领域:

Inactivated Bacterial Vaccine

授权状态:

Authorized

授权日期:

2021-11-24

产品特点

Revised: August 2022
AN: 00754/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suiseng Diff/A suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCES:
_Clostridioides difficile_, toxoid A (TcdA)
≥ 1.60 RP*
_Clostridioides difficile_, toxoid B (TcdB)
≥ 1. 65 RP*
_Clostridium perfringens_ type A, α-toxoid
≥ 1.34 RP*
* RP: Relative Potency determined by ELISA
ADJUVANTS:
Aluminium hydroxide gel
0.6 g
Ginseng extract (equivalent to ginsenosides)
DEAE-dextran
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Yellowish-white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (pregnant sows and gilts).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the passive immunisation of neonatal piglets by means of the
active
immunisation of breeding sows and gilts:
-
to prevent mortality and reduce clinical signs and macroscopic lesions
caused by
_C. difficile, _toxins A and B_._
-
to reduce clinical signs and macroscopic lesions caused by _C.
perfringens_ type
A, α-toxin.
The reduction of the occurrence of neonatal diarrhoea has been
demonstrated under
field conditions.
Onset of immunity:
Protection was demonstrated in suckling piglets on the first day of
life in challenge
studies.
Revised: August 2022
AN: 00754/2022
Page 2 of 5
Duration of immunity:
Neutralising protective antibodies transferred via colostrum to the
piglets were
present up to 28 days after birth in the majority of the piglets.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
the adjuvant or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Protection of piglets is achieved by colostrum intake. Therefore, care
should be taken
to ensure that each piglet ingests a sufficient quantity of colostrum
within the first
hours of life.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for