Suiseng Diff/A
Authorised
This medicine is authorised for use in the European Union
clostridioides difficile / clostridium perfringens vaccine, inactivated
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Suiseng Diff/A is a veterinary vaccine given to sows (female pigs that have already given birth to piglets) or gilts (female pigs that have not yet given birth to piglets) to protect their offspring from intestinal disease caused by toxins produced by the bacteria Clostridioides difficile (toxins A and B) and Clostridium perfringens type A (alpha toxin). Suiseng Diff/A contains versions of the toxins that have been inactivated so they cannot cause disease, called toxoid A, toxoid B and alpha toxoid.
Suiseng Diff/A can only be obtained with a prescription and is available as a suspension for injection. It is given into the neck muscles of pregnant pigs. The initial vaccination course is two injections given three weeks apart, with the second injection given three weeks before farrowing (giving birth). In each following pregnancy, sows that have previously been vaccinated according to this schedule should be given a single revaccination three weeks before the expected farrowing date.
Suiseng Diff/A is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Suiseng Diff/A contains inactivated toxins produced by the bacteria Clostridioides difficile and Clostridium perfringens type A. When Suiseng Diff/A is given to sows or gilts, the pig’s immune system recognises the inactivated bacterial toxins as ‘foreign’ and makes antibodies against them. These antibodies are transferred from the mother to the piglets through the colostrum (first milk), and they help the piglets to fight Clostridioides difficile or Clostridium perfringens type A infections if they become exposed to the bacteria after birth. Protection of the offspring starts within 24 hours after birth and lasts up to 28 days of life in the majority of piglets.
Suiseng Diff/A also contains adjuvants (aluminium hydroxide, ginseng extract and diethylaminoethyl-dextran) to stimulate a better immune response.
Suiseng Diff/A has been shown to prevent death and reduce the clinical signs, such as neonatal piglet diarrhoea, and intestinal lesions caused by Clostridioides difficile toxins A and B, and to reduce the clinical signs and intestinal lesions caused by Clostridium perfringens alpha toxin.
Two laboratory studies were conducted in newborn piglets to assess the efficacy of Suiseng Diff/A. The first study showed that protection began 24 hours after birth. The second study confirmed the effectiveness after revaccination.
Data from one field study were presented to support the results of the laboratory studies, where a reduction in the occurrence of neonatal piglet diarrhoea was demonstrated. This study also demonstrated that protective antibodies lasted for up to 28 days in the majority of piglets.
The most common side effects with Suiseng Diff/A (which may affect up to 1 in 10 animals) are a transient increase in body temperature on the day of vaccination and swelling at the injection site that resolves without treatment within five days.
None.
The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
The withdrawal period for meat from pigs vaccinated with Suiseng Diff/A is ‘zero’ days, which means that there is no mandatory waiting time.
The European Medicines Agency decided that Suiseng Diff/A’s benefits are greater than its risks and it can be authorised for use in the EU.
Suiseng Diff/A received a marketing authorisation valid throughout the EU on 07/12/2021.
Product information
Product details
- Name of medicine
- Suiseng Diff/A
- Active substance
- Clostridioides difficile toxoid A
- Clostridioides difficile toxoid B
- Clostridium perfringens, type A, alpha toxoid
- International non-proprietary name (INN) or common name
- clostridioides difficile
- clostridium perfringens vaccine, inactivated
- Species
- Pigs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AB12
Pharmacotherapeutic group
Immunologicals for Suidae, inactivated bacterial vaccines for pigs, clostridiumTherapeutic indication
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.
News on Suiseng Diff/A
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