Enteroporc COLI AC (Canada)

Company: Ceva Animal Health

Clostridium perfringens type A & C-Escherichia coli Bacterial Extract-Toxoid

Lyophilisate and suspension for suspension for injection for pigs

FOR VETERINARY USE ONLY

Description

The active immunization of pregnant sows and gilts induces the formation of antibodies against the alpha, beta1 and beta2 toxins of C. perfringens types A/C and against the E. coli fimbrial adhesins F4ab, F4ac, F5 and F6. The piglets are then passively immunized 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.

One dose (2 mL) contains:

Active substances:

Lyophilisate:

Clostridium perfringens type A/C toxoids:

Suspension:

Inactivated fimbrial adhesins of Escherichia coli:

* toxoid content and fimbrial adhesins content in relative units per mL, determined in ELISA against an internal standard

Adjuvant:

Enteroporc COLI AC Indications

For the passive immunization of progeny by active immunization of pregnant sows and gilts to reduce:

- Clinical signs (severe diarrhea) and mortality caused by E. coli strains expressing the adhesins F4ab, F4ac, F5 and F6.

- Clinical signs (diarrhea) 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 necrotizing enteritis caused by Clostridium perfringens type C expressing beta1 toxin.

Onset of immunity (after uptake of colostrum):

Duration of immunity:

DOSAGE AND ADMINISTRATION

Intramuscular use.

Inject one dose (2 mL) of vaccine into the neck muscles in the area behind the ear of each pig.

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.

Directions For Use

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 the 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.

WARNINGS

Keep out of sight and reach of children.

Withdrawal Period: 21 days.

CAUTIONS

- Vaccinate healthy animals only.

- 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.

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

ADVERSE REACTIONS

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.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in the package leaflet or you think that the medicine has not worked, please inform your veterinarian.

PRESENTATION

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.

STORAGE

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

Protect from light.

Do not freeze.

Do not use this veterinary medicinal product after expiry date which is stated on the carton.

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.

MANUFACTURED BY:

IDT Biologika GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany

IMPORTED BY:

Ceva Animal Health Inc., 150 Research Lane, Suite 225, Guelph ON N1G 4T2

A5351

CPN: 1221166.0