Enteroporc Coli AC - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Enteroporc COLI AC lyophilisate and suspension for suspension for injection for pigs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Ceva Santé Animale

10 av. de La Ballastière

33500 Libourne

France

Manufacturer responsible for batch release :

IDT Biologika GmbH

Am Pharmapark

06861 Dessau-Rosslau

Germany

Ceva-Phylaxia Veterinary Biologicals Co. Ltd.

Szâllâs u. 5.

1107 Budapest

Hungary

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Enteroporc COLI AC

lyophilisate and suspension for suspension for injection for pigs

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One dose (2 ml) contains:

Active substances:

Lyophilisate:

Clostridium perfringens type A/C toxoids:

alpha toxoid > 125 rU/ml*

betal toxoid > 3354 rU/ml*

beta2 toxoid > 794 rU/ml*

Suspension:

Inactivated fimbrial adhesins of Escherichia coli :

F4ab > 23 rU/ml*

F4ac > 19 rU/ml*

> 13 rU/ml*

> 37 rU/ml

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

Adjuvant:

Aluminium (as hydroxide)

Beige to brown lyophilisate.

Yellowish suspension.

• 4. INDICATIONS

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

• – Clinical signs (severe diarrhoea) and mortality caused by E. coli strains expressing the 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 necrotizing 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:

E coli F4ab, F4ac, F5 , F6: first days of life

• C. perfringens type A : 14 days of life

• C. perfringens type C: 21 days of life

• 5. CONTRAINDI­CATIONS

None.

• 6. 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 this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Pigs (pregnant sows and gilts).

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Intramuscular use.

Inject one dose (2 ml) of vaccine onto 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.

• 9. ADVICE ON CORRECT ADMINISTRATION

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.

• 10. WITHDRAWAL PERIOD

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

• 12. SPECIAL WARNINGS

Special warnings for each target species:

Vaccinate healthy animals only.

Special precautions for use in animals :

Not applicable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals :

None.

Pregnancy and lactation:

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.

Overdose (symptoms, emergency procedures, antidotes) :

Not applicable.

Incompatibilities :

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

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION