Patient leaflet - Neocolipor
B. PACKAGE LEAFLET
PACKAGE LEAFLET: Neocolipor
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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
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
MANUFACTURER FOR THE BATCH RELEASE
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
F-69800 SAINT PRIEST
FRANCE
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Neocolipor suspension for injection
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 2 ml:
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E. coli adhesin F4 (F4ab, F4ac, F4ad), at least…2.1 SA.U*
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E. coli adhesin F5, at least...........................1.7 SA.U*
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E. coli adhesin F6, at least.........1.4 SA.U*
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E. coli adhesin F41, at least.........1.7 SA.U*
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*: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.
Adjuvant:
Aluminium (as hydroxide)............................................................................................................. 1.4 mg
4.
INDICATION(S)
Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41.
6.
ADVERSE REACTIONS
Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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7. TARGET SPECIES
Pigs (sows and gilts)
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
One 2 ml dose according to the following schedule:
Primary vaccination:
First injection: 5 to 7 weeks before farrowing
Second injection: 2 weeks before farrowing.
Revaccination: 1 injection 2 weeks before each subsequent farrowing.
9.
ADVICE ON CORRECT ADMINISTRATION
Intramuscular injection in the neck in the area behind the ear.
Shake the vial vigorously before use.
Use sterile syringe and needles. Administer using aseptic procedures.
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10. WITHDRAWAL PERIOD(S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Store and transport at 2°C – 8°C, protected from light. Do not freeze.
Shelf life of broached vial: 3 hours.
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12. SPECIAL WARNING(S)
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– Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth.
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– Vaccinate only healthy animals.
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– Do not administer in conjunction with other medicinal products.
No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
In the case of accidental self-injection, seek medical advice immediately and show the package insert or label to a physician.
Wash and disinfect hands after use.
No undesirable effects have been observed after the administration of twice the recommended dosage.
Do not mix with any other vaccine.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY