Target species
Pigs (sows and gilts)
Indications for use
Piglets: For the passive protection of neonatal piglets by means of the active immunisation of breeding sows and gilts to reduce mortality and clinical signs of neonatal enterotoxicosis, such as diarrhoea caused by enterotoxigenic Escherichia coli, which express F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) adhesins.
The persistence of these antibodies has not been established.
For the passive immunisation of neonatal piglets against Necrotic Enteritis by means of the active immunisation of breeding sows and gilts to induce seroneutralising antibodies against the β-toxin of Clostridium perfringens type C .
The persistence of antibodies has not been established
Sows and gilts: For active immunisation of breeding sows and gilts to induce seroneutralising antibodies against α-toxin of Clostridium novyi type B. The relevance of the seroneutralising antibodies was not experimentally determined.
Antibodies have been detected 3 weeks after completion of the basic vaccination scheme. The persistence of these antibodies has not been established.
Contra-indications
None
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in target species
Not applicable
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable.
Adverse reactions
Pigs (sows and gilts).
Common (1 to 10 animals / 100 animals treated): . | Elevated temperature 1 Injection site reaction 2 . |
Uncommon (1 to 10 animals / 1000 animals treated): . | Injection site nodules 3 . . |
Very rare (<1 aniamal / 10,000 animals treated, including isolated reports): . | Injection site granuloma . . |
Undetermined frequency (cannot be estimated from the available data) | Hypersensitivity reactions 4 . |
1 Temperature increase observed at 6 hours post-vacciantion (mean 0.4ºC, in individual pigs u to 1.2ºC, uncommonly up to 2ºC) subsiding without treatments within 24 hours post-vacciantion.
2 Palpable inflammation local reaction (swelling, not more than 2 cm2) which resolves without treatment within 5 days post-vaccination.
3 Resolve within 2-3 weeks post-vaccination.
4 Reactions can be life-threatening in sensitive animals. If such a reaction occurs, appropriate treatment should be administered without delay.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via de national reporting system. See package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy from 6 weeks before the expected farrowing date.
Interactions 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 Diff/A. 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. 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.
Administration route and dosage
Intramuscular use.
Dose: 2 ml/animal.
The basic vaccination scheme consists of two doses: the first dose at approximately 6 weeks before farrowing and a second dose at approximately 3 weeks before the expected date of farrowing.
It is recommended that the second dose should be given preferably on alternate sides of the neck.
Re-vaccination: on each subsequent gestation, administer one dose 3 weeks before the expected date of farrowing.
It is advisable to administer the vaccine at a temperature between +15ºC and +25ºC.
Shake before use.
To ensure the correct mixing with Suiseng Diff/A, 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
None known.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal product in order to limit the risk of development of resistance.
None known.
Withdrawal periods
Meat and offal: Zero days