Patient leaflet - Porcilis ColiClos
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Porcilis ColiClos 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:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer(s) responsible for batch release:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
MSD Animal Health UK Ltd
Walton Manor, Walton, Milton Keynes
Buckinghamshire, MK7 7AJ, UK
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis ColiClos suspension for injection for pigs
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each dose of 2 ml contains:
Active substances:
Escherichia coli components:
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– F4ab fimbrial adhesin
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– F4ac fimbrial adhesin
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– F5 fimbrial adhesin
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– F6 fimbrial adhesin
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– LT toxoid
Clostridium perfringens component: – Type C (strain 578) beta toxoid
> 9.7 log2 Ab titre1 > 8.1 log2 Ab titre1 > 8.4 log2 Ab titre1 > 7.8 log2 Ab titre1 > 10.9 log2 Ab titre1
>20 IU2
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1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/40 sow dose
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2 International units of beta antitoxin according to Ph. Eur.
Adjuvant:
dl-a-tocopheryl acetate
150 mg
Aqueous, white to nearly white suspension for injection.
4.
INDICATION(S)
For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those E. coli strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by C. perfringens type C.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
In laboratory studies and field trials:
An increase in body temperature up to 2°C was very commonly observed on the day of vaccination. Reduced activity and lack of appetite on the day of vaccination commonly occurred and/or a sometimes painful and hard swelling up to 10 cm diameter for up to 25 days were very commonly observed at the site of injection.
In post marketing experience:
Hypersensitivity reactions may occur in very rare cases.
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 (sows and gilts)
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use.
Administer 1 dose (2 ml) of vaccine per animal in the neck in the area behind the ear.
Vaccination scheme:
Primary vaccination : Sows/gilts which have not yet been vaccinated with the product are given a primary injection 6 to 8 weeks before the expected date of farrowing and a second injection 4 weeks later.
Revaccination : A single revaccination is carried out 2 to 4 weeks before the expected date of farrowing.
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9. ADVICE ON CORRECT ADMINISTRATION
Before use allow the vaccine to reach room temperature.
Shake vigorously before use and at intervals during use.
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10. WITHDRAWAL PERIOD(S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf life after first opening the container: 10 hours.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
Special precautions for use in animals :
Protection of piglets is achieved by colostrum intake. Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy :
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) :
A slight redness and/or roughness may transiently occur after a double dose vaccination. No adverse reactions other than those mentioned in section “Adverse Reactions” have been observed.
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
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