Suiseng Diff/A
Active substance
ATC code
Species
Pigs (pregnant sows and gilts).
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 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.
Dose to be administered and administration route
Administer the vaccine by deep intramuscular injection in the neck muscles.
Allow the vaccine to reach room temperature (15°C to 25 °C) before use. Shake well before use.
Primary vaccination:
Administer one dose (2 ml) at approximately 6 weeks before farrowing and a second dose (2 ml) at approximately 3 weeks before farrowing.
It is recommended that the second dose is given preferably on alternate sides.
Revaccination:
On each subsequent gestation, administer one dose (2ml) 3 weeks before the expected date of farrowing.
To ensure the correct mixing with Suiseng Coli/C, the same volumes of Suiseng Diff/A and Suiseng Coli/C should be used. All the contents of Suiseng Coli/C should be transferred into a headspace bottle of Suiseng Diff/A (50 ml bottle with 10 doses, 100 ml bottle with 25 doses and 250 ml bottle with 50 doses).
A pre-sterilised transfer needle can be used according to the following instructions:
- Peel the cap of the bottle containing the vaccine Suiseng Coli/C.
- Connect one end of the transfer needle to the bottle of Suiseng Coli/C.
- Peel the cap of the headspace bottle containing the vaccine Suiseng Diff/A.
- Connect the opposite end of the transfer needle to the bottle of Suiseng Diff/A.
- Transfer all the contents of Suiseng Coli/C into the bottle of Suiseng Diff/A. - Once finished, separate both bottles and discard the needle transfer.
Shake well before use. Administer one single dose of 4 ml of the mixed vaccines.
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 laboratory studies.
A slight transient increase in body temperature (mean 0.27ºC, in individual pigs up to 0.95 ºC) which subsided without treatment occurred commonly in preclinical and field studies.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
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 * RP: Relative Potency determined by ELISA Adjuvants: |
≥ 1.34 RP* |
|
Aluminium hydroxide gel Ginseng extract (equivalent to ginsenosides) DEAE-dextran |
0.6 g |
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
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 administering the veterinary medicinal product to animals
None.
4.6 Adverse reactions (frequency and seriousness)
Mild local inflammation at the injection site (maximum diameter of 5 cm) which subsided without treatment within 5 days was commonly reported in laboratory studies.
A slight transient increase in body temperature (mean 0.27ºC, in individual pigs up to 0.95 ºC) which subsided without treatment occurred commonly in preclinical and field studies.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9 Amounts to be administered and administration route
Administer the vaccine by deep intramuscular injection in the neck muscles.
Allow the vaccine to reach room temperature (15°C to 25 °C) before use. Shake well before use.
Primary vaccination:
Administer one dose (2 ml) at approximately 6 weeks before farrowing and a second dose (2 ml) at approximately 3 weeks before farrowing.
It is recommended that the second dose is given preferably on alternate sides.
Revaccination:
On each subsequent gestation, administer one dose (2ml) 3 weeks before the expected date of farrowing.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccines for pigs, clostridium. ATCvet code: QI09AB12.
The active immunisation of pregnant sows and gilts induces the production of neutralising antibodies against C. difficile, toxins A and B and C. perfringens type A, αtoxin. These antibodies are transferred via the colostrum to the piglets. The uptake of sufficient colostrum within the first hours of life results in a passive protection of piglets.
Efficacy of the vaccine was demonstrated upon intraperitoneal challenge with C. difficile toxin A and B and alpha toxin from C. perfringens type A. The efficacy of the vaccine to reduce the occurrence of diarrhoea was demonstrated under field conditions.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Aluminium hydroxide gel
Ginseng extract
Simethicone
DEAE-dextran
Disodium phosphate dodecahydrate
Potassium chloride
Potassium dihydrogen phosphate
Sodium chloride
Sodium hydroxide
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 10 hours.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
20 ml, 50 ml, 100 ml and 250 ml PET bottles, closed with bromobutyl-stoppers and aluminium caps.
Pack sizes
- Cardboard box with 1 PET bottle of 10 doses (20 ml bottle).
- Cardboard box with 1 PET bottle of 10 doses (50 ml bottle).
- Cardboard box with 1 PET bottle of 25 doses (50 ml bottle).
- Cardboard box with 1 PET bottle of 25 doses (100 ml bottle).
- Cardboard box with 1 PET bottle of 50 doses (100 ml bottle).
- Cardboard box with 1 PET bottle of 50 doses (250 ml bottle).
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Laboratorios Hipra SA
Avda La Selva 135
17170 Amer (Girona)
Spain
8. MARKETING AUTHORISATION NUMBER
Vm 17533/5013
9. DATE OF FIRST AUTHORISATION
24 November 2021
10. DATE OF REVISION OF THE TEXT
August 2022
Approved: 10 August 2022
