Each dose (2 ml) contains:

Active substances: Lyophilisate:

Clostridium perfringens type A/C toxoids: alpha toxoid ≥ 125 rU/ml* beta1 toxoid ≥ 3354 rU/ml* beta2 toxoid ≥ 794 rU/ml*

Suspension: Inactivated fimbrial adhesins of Escherichia coli: F4ab ≥ 23 rU/ml* F4ac ≥ 19 rU/ml* F5 ≥ 13 rU/ml* F6 ≥ 37 rU/ml*

* toxoid and fimbrial adhesins content in relative units per ml, determined by ELISA against an internal standard Adjuvant: Aluminium (as hydroxide) 2.0 mg/ml For the full list of excipients, see Pharmaceutical Particulars.

Lyophilisate and suspension for suspension for injection. Beige to brown lyophilisate. Yellowish suspension.

Pigs (pregnant sows and gilts)

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

None

Vaccinate healthy animals only.

Not applicable.

None.

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.

Can be used during pregnancy

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.

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

Not applicable.

Zero days.

Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccines. ATC vet code: QI09AB08.

The active immunisation of pregnant sows and gilts induces the formation of antibodies against the alpha, beta1 and beta2 toxins of C. perfringens types A and C and against E. coli fimbrial adhesins F4ab, F4ac, F5 and F6. The piglets are then passively immunised by the uptake of colostrum that contains those specific antibodies.

Efficacy of the vaccine has been demonstrated upon intraperitoneal challenge with a combination of alpha and beta2 toxins from C. perfringens type A. This toxin pattern is representative for the majority of C. perfringens type A isolates in the field associated with neonatal enteritis. Both toxins have been proposed to play a role in the pathogenesis.

Lyophilisate: Sucrose Suspension: Aluminium hydroxide Sodium chloride Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate Water for injection

Do not mix with any other veterinary medicinal product, except the suspension supplied for use with the veterinary medicinal product

Shelf life of the veterinary medicinal product as packaged for sale: 21 months. Shelf life after reconstitution according to directions: 8 hours. Until use the reconstituted vaccine should be stored at 2-8 °C.

After removal of the reconstituted vaccine from storage at 2-8 °C, the vaccine should be used immediately.

Store and transport refrigerated (2 °C – 8 °C).

Protect from light. Do not freeze

Lyophilisate: 10 ml glass (type I) vials containing 10 or 25 doses

Suspension: 25 ml PET or glass (type I) vials containing 10 doses (20 ml) 50 ml PET or glass (type II) vials containing 25 doses (50 ml)

The vials are closed with bromobutyl rubber stoppers and sealed with aluminium crimp caps.

Pack sizes:

10 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 glass vial (20 ml) of suspension 10 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 PET vial (20 ml) of suspension 25 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 glass vial (50 ml) of suspension.

25 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 PET vial (50 ml) of suspension Not all pack sizes may be marketed

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements

UK (GB) :Vm 15052/5002

UK (NI): Vm EU/2/20/262/001-004

09 December 2020

October 2022