Target species
Pigs (pregnant sows and gilts)
Indications for use, specifying the target species
For the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce:
- Clinical signs (severe diarrhoea) and mortality caused by Escherichia coli strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6
- Clinical signs (diarrhoea during the first days of life) associated with Clostridium perfringens type A expressing alpha and beta2 toxins
- Clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by Clostridium perfringens type C expressing beta1 toxin
Onset of immunity (after uptake of colostrum):
E. coli F4ab, F4ac, F5, F6: within 12 hours after birth
C. perfringens type A and C: First day of life
Duration of immunity (after uptake of colostrum):
E. coli F4ab, F4ac, F5, F6: first days of life
C. perfringens type A: 14 days of life
C. perfringens types C: 21 days of life
Contraindications
None
Special warnings for each target species
Vaccinate healthy animals only.
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)
A transient increase in body temperature (mean 0.5 °C, in individual pigs up to 2 °C) occurred very commonly on the day of vaccination which returned to normal within 24 hours. A transient swelling and redness at the injection site (mean 2.8 cm, in individual pigs up to 8 cm) was very commonly observed which disappeared without treatment within 7 days. A slightly depressed behaviour was commonly observed on the days of vaccination.
Use during pregnancy, lactation or lay
Can be used during pregnancy
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.
Amounts to be administered and administration route
Intramuscular use. Inject one dose (2 ml) of vaccine into the neck muscles in the area behind the ear of each pig.
Vaccination scheme:
Primary vaccination:
First vaccination: one dose 5 weeks before the expected date of farrowing.
Second vaccination: one dose 2 weeks before the expected date of farrowing.
Revaccination (before each subsequent farrowing): one dose 2 weeks before the expected date of farrowing.
Preparation of the vaccine:
1. To reconstitute the vaccine, use an appropriately sized sterile syringe to withdraw approximately 5 ml of the suspension and transfer it into the vial containing the lyophilisate.
2. Shake gently until the lyophilisate is completely dispersed in the suspension.
3. Then withdraw all the contents of the lyophilisate vial into the same syringe and transfer them back into the suspension vial.
4. Shake well until thoroughly mixed.
5. Withdraw approximately 5 ml of the reconstituted vaccine suspension and transfer it into lyophilisate vial. Shake the vial. Then withdraw the contents and transfer them back into the vaccine suspension vial.
The vaccine is ready to use. The reconstituted vaccine is a yellowish brown to reddish brown suspension
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal period(s)
Zero days.