Summary of medicine characteristics - Coliprotec F4/F18
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliprotec F4/F18 lyophilisate for oral suspension for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine contains:
Active substances:
Live non-pathogenic Escherichia coli O8:K87* (F4ac):.......................1.3×108 to 9.0×108 CFU
Live non-pathogenic Escherichia coli O141:K94* (F18ac):...............2.8×108 to 3.0×109 CFU
not attenuated
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**CFU – colony forming units
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate for oral suspension.
White or whitish powder.
4. CLINICAL PARTICULARS4.1 Target species
Pigs.
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4.2 Indications for use, specifying the target species
For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18-positive Escherichia coli in order to:
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– reduce the incidence of moderate to severe post-weaning E. coli diarrhoea (PWD) in infected pigs;
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– reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive E. coli from infected pigs.
Onset of immunity: 7 days after vaccination
Duration of immunity: 21 days after vaccination
4.3 Contraindications
None.
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4.4 Special warnings for each target species
It is not recommended to vaccinate animals undergoing immunosuppressive treatment or to vaccinate animals undergoing antibacterial treatment effective against E. coli.
Vaccinate healthy animals only.
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4.5 Special precautions for use
Special precautions for use in animals
The vaccine strains may be excreted by vaccinated piglets for at least 14 days following vaccination. The vaccine strains readily spread to other pigs in contact to vaccinated pigs. Unvaccinated pigs in contact with vaccinated pigs will harbour and shed the vaccine strains similarly to vaccinated pigs. During this time, the contact of immunosuppressed pigs with vaccinated pigs should be avoided.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the veterinary medicinal product.
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician. In case of spillage onto skin, rinse with water and seek medical advice immediately and show the package leaflet or the label to the physician.
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4.6 Adverse reactions (frequency and seriousness)
No adverse reactions have been observed.
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4.7 Use during pregnancy, lactation or lay
The use is not recommended during pregnancy.
4.8 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.
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4.9 Amounts to be administered and administration route
Oral use.
Vaccination schedule: administer a single dose orally from 18 days of age.
All materials used in preparing and administering the vaccine must be free of antimicrobials, detergent or disinfectant residues to prevent inactivation.
The reconstituted vaccine is a transparent to opaque white-yellowish suspension depending on the volume of water used for dilution.
Vaccination by drench application :
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– 50-dose presentation: Reconstitute the lyophilisate by adding 10 ml of water to the vial. Shake well and transfer the suspension into a graduated container, mix again with water to complete to a total volume of 100 ml. Shake well and use within 4 hours. Administer a single 2 ml dose orally to pigs, irrespective of body weight.
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– 200-dose presentation: Reconstitute the lyophilisate by adding 20 ml of water to the vial. Shake well and transfer the suspension into a graduated container, mix again with water to complete to a total volume of 400 ml. Shake well and use within 4 hours. Administer a single 2 ml dose orally to pigs, irrespective of body weight.
Vaccination via the drinking water system:
The drinking water systems have to be cleaned and intensively rinsed with untreated water to avoid any residues of antimicrobials, detergents or disinfectants.
Withhold drinking water supply for 1 to 2 hours prior to the planned vaccination to stimulate drinking of the vaccine suspension.
Reconstitute the lyophilisate by adding 10 ml (50-dose presentation) or 20 ml (200-dose presentation) of water to the vial. Shake well.
The final suspension containing the vaccine should be consumed within 4 hours after preparation. Provide enough space so that all pigs can drink the required amount. The actual amount of water consumed may however vary considerably depending on several factors. Therefore, it is recommended to assess the actual water intake during a 4-hour time period the day before vaccination. Alternatively, refer to the following table:
| Body weight (kg) | Water consumption (litres) in a 4-hour time period | ||
| 1 Pig | 50 pigs | 200 pigs | |
| Up to 4.5 | 0.11 litres | 5.5 litres | 22 litres |
| 4.6 to 6.8 | 0.17 litres | 8.5 litres | 34 litres |
| 6.9 to 9.0 | 0.23 litres | 11.5 litres | 46 litres |
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– For administration using bowls or tanks, dilute the reconstituted vaccine in the volume of water that the pigs will drink during a 4-hour time period.
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– For administration through water lines using a dosing pump (proportioner), dilute the reconstituted vaccine in the needed volume of the dosing pump stock solution. The volume of stock solution is calculated using the volume of water that the pigs will drink during a 4-hour time period multiplied by the dosing pump rate (in decimal). As an example, for a 4-hour consumption of 22 litres and a dosing pump rate of 1%, the volume of the stock solution should be 22 litres x 0.01 = 220 ml.
In case of concerns about the presence of disinfectant residues in the drinking water, such as chlorine, it is recommended to add skimmed milk powder as a stabilizer into the drinking water prior to adding the vaccine. The final concentration of the skimmed milk powder should be 5 g/litre.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
A rectal temperature up to 41.2 °C may occur in individual animals within the first 24 hours after administration of a 10-fold overdose.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Suidae; live bacterial vaccine. ATCvet code: QI09AE03.
To stimulate active immunity against enterotoxigenic F4-positive and F18-positive E. coli in pigs.
The vaccine induces an intestinal immunity and a serological response against F4-positive and F18-positive E. coli in pigs. The vaccine confers cross protection against F18ab-positive E. coli, as demonstrated by challenge for both the 7-day onset of immunity and the 21-day duration of immunity. Antibodies triggered by the vaccine provide cross-reactivity against F4ab and F4ad-positive E. coli strains.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Dextran 40,000
Sucrose
Monosodium glutamate
Purified water
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after reconstitution and dilution according to directions: 4 hours.
6.4. Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light.
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6.5 Nature and composition of immediate packaging
Type I glass vial of 11 ml containing 50 doses and type II glass vial of 50 ml containing 200 doses with a chlorobutyl rubber stopper sealed with an aluminium cap.
Cardboard box of one vial of 50 or 200 doses.
Cardboard box of four vials of 50 doses.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
GERMANY
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/16/202/001–003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 09/01/2017
Date of last renewal: