Target species
Pigs (pregnant sows and gilts).
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 Clostridioides difficile, toxins A and B.
•to reduce clinical signs and macroscopic lesions caused by Clostridium 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.
Contraindications
Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
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.
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.
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)
Use during pregnancy, lactation or lay
Can be used during pregnancy.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered at one injection site with Suiseng Coli/C. Following administration of the mixed vaccines, an increase in body temperature (mean 1.43°C, not exceeding 1.87°C in individual pigs) during the first 6 hours after vaccination occurs very commonly. Injection site swelling (maximum 4 cm) occurs very commonly, but typically will resolve within 4 days.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.
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.
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 the 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.
Withdrawal period(s)
Zero days.