Suiseng Diff/A

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Clostridioides difficile toxoid A, Clostridioides difficile toxoid B, Clostridium perfringens, type A, alpha toxoid

Available from:

Laboratorios Hipra, S.A.

ATC code:

QI09AB12

INN (International Name):

clostridioides difficile, clostridium perfringens vaccine, inactivated

Therapeutic group:

Pigs

Therapeutic area:

Immunologicals for Suidae, inactivated bacterial vaccines for pigs, clostridium

Therapeutic indications:

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 Clostridioides difficile toxins A and B.- to reduce clinical signs and macroscopic lesions caused by Clostridium perfringens type A, alpha toxin.

Authorization status:

Authorised

Authorization date:

2021-12-07

Patient Information leaflet

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
Suiseng Diff/A suspension for injection for pigs
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
Laboratorios Hipra, S.A.
Avda. la Selva, 135
17170 Amer (Girona) SPAIN
Tel. [phone] - Fax. [phone]
E-mail: [e-mail]
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suiseng Diff/A suspension for injection for pigs.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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
Yellowish-white suspension.
4.
INDICATION(S)
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.
Duration of immunity:
18
Neutralising protective antibodies transferred via colostrum to the
piglets were present up to 28 days
after birth in the majority of the piglets.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
the adjuvant or to any of the
excipients.
6.
ADVERSE REACTIONS
Mild local inflammation at the injection site (maximum diameter of 5
cm) which subsided without
treatment within 5 days was commonly reported in laborato

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
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
3
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 use in animals
Not applicable.
Special precautions to be taken by the person ad