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
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-vacciantion.
3 Resolve within 2-3 weeks post-vacciantion.
4 Reactions can be life-threatening in sensitive animals. If such a reaction occurs, appropiate 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.
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.
Amounts to be administered and administration route
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.
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.
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