Patient leaflet - Enteroporc Coli
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Enteroporc COLI suspension for injection for pigs
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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
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Enteroporc COLI suspension for injection for pigs
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3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENT
One dose (2 ml) contains:
Active substances:
Inactivated fimbrial adhesins of Escherichia coli :
F4ab > 23 rU/ml*
F4ac > 19 rU/ml*
F5 > 13 rU/ml*
F6 > 37 rU/ml
fimbrial adhesins content in relative units per ml, determined in ELISA against an internal standard
Adjuvant:
2.0 mg/ml
Aluminium (as hydroxide)
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.
Onset of immunity (after uptake of colostrum): within 12 hours after birth
Duration of immunity (after uptake of colostrum): first days of life.
5.
CONTRAINDICATIONS
None.
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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 days 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:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– 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.
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7. TARGET SPECIES
Pigs (pregnant sows and gilts).
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8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Intramuscular use.
Inject one dose (2ml) 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
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9. ADVICE ON CORRECT ADMINISTRATION
Shake the vaccine well before use.
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10. WITHDRAWAL PERIOD
Zero days.
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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 the expiry date which is stated on the label and carton.
Shelf life after first opening the container: Use immediately
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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 :
Not applicable.
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.
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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.
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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.
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15. OTHER INFORMATION
Immunological properties
The active immunisation of pregnant sows and gilts induces the formation of antibodies against the
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E. coli fimbrial adhesins F4ab, F4ac, F5 and F6. Piglets are then passively immunised by the uptake of colostrum that contains those specific antibodies.