Summary of medicine characteristics - Coliprotec F4
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliprotec F4 lyophilisate for oral suspension for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine contains:
Live non-pathogenic Escherichia coli O8:K871.(F4ac)
1not attenuated
2CFU – colony forming units
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White or whitish lyophilisate for oral suspension.
4.
4.1
Pigs
1.3 x108 to 9.0 x108 CFU2/dose
4.2 Indications for use, specifying the target species
For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive Escherichia coli in order to:
reduce the incidence of moderate to severe post-weaning Escherichia coli diarrhoea (PWD) in pigs.
reduce the colonisation of the ileum and faecal shedding of enterotoxigenic F4-positive Escherichia coli from infected pigs.
Onset of immunity: 7 days after vaccination.
Duration of immunity: 21 days after vaccination.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Do not vaccinate animals undergoing immunosuppressive treatment.
Do not vaccinate animals undergoing antibacterial treatment effective against Escherichia coli.
Vaccinate healthy animals only.
4.5 Special precautions for use
Special precautions for use in animals
Apply the usual aseptic precautions to all administration procedures.
The vaccine strain may be excreted by vaccinated piglets for at least 14 days following vaccination. The vaccine strain readily spreads to other pigs in contact to vaccinated pigs. Unvaccinated pigs in contact with vaccinated pigs will harbour and shed the vaccine strain 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 safe worn when handling the veterinary medicinal product.
es should be
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.
4.6 Adverse reactions (frequency and seriousness)
A transient reduced weight gain was observed during the first week after vaccination in studies. Shivering was very commonly observed after vaccination in studies.
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).
4.7 Use during pregnancy, lactation or lay
The use of this veterinary medicinal product 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.
4.9 Amounts to be administered and administration route
Oral use and in drinking water use.
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 schedule: administer a single dose orally from 18 days of age.
Oral use. Vaccination by drench application :
- • 50-dose presentation: Reconstitute the lyophilisate by adding 5 ml of tap water to the vial. Shake well and transfer the suspension into a graduated container, mix again with tap water to complete to a total volume of 100 ml. Shake well and use immediately. Administer a single 2 ml dose orally to pigs (from 18 days of age), irrespective of body weight.
- • 200-dose presentation: Reconstitute the lyophilisate by adding 10 ml of tap water to the vial. Shake well and transfer the suspension into a graduated container, mix again with tap water to complete to a total volume of 400 ml. Shake well and use immediately. Administer a single 2 ml dose orally to pigs (from 18 days of age), irrespective of body weight.
The suspension should be administered within 4 hours after preparation.
In drinking water use. Vaccination via the drinking water :
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 5 ml (50-dose presentation) or 10 ml (200-dose presentation) of tap 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 in a 4-hour time period of number of pig(s) | ||
| 1 | 50 | 200 | |
| 4.5 | 0.11 l | 5.5 l | 22 l |
| 6.8 | 0.17 l | 8.5 l | 34 l |
| 9.0 | 0.23 l | 11.5 l | 46 l |
- • 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.
- • 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 l and a dosing pump rate of 1%, the volume of the stock solution should be 22 l x 0.01 = 220 ml.
In case of concerns about the presence of disinfectant residues in the drinking water, 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/l.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions other than those stated under section 4.6 have been observed after administration of 10 times the recommended dose.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunologicals for Suidae live bacterial vaccines for pigs.
ATCvet code: QI09AE03.
To stimulate active immunity against enterotoxigenic F4-positive Escherichia coli in pigs.
Live non-pathogenic vaccine to reduce diarrhoea, faecal shedding and intestinal colonization associated with F4-positive enterotoxigenic Escherichia coli in pigs.
The vaccine induces an intestinal immunity and a serological response against F4-positive Escherichia coli in pigs.
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
6.4. Special precautions for storage°C).
6.5 Nature and composition of immediate packaging
Type I glass vial of 6 ml containing 50 doses and of 11 ml containing 200 doses with a chlorobutyl rubber stopper sealed with an aluminum cap.
Cardboard box of one vial of 50 doses.
Cardboard box of one vial of 200 doses.
Cardboard box of four vials of 50 doses.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Prevtec Microbia GmbH Geyerspergerstr 27 80689 München GERMANY
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency