Coliprotec F4
Escherichia coli, type 08, strain K87 (live)
14
Medicinal product no longer authorised
Coliprotec F4
lyophilisate for oral suspension for pigs
authorised
Marketing authorisation holder: Prevtec Microbia GmbH Geyerspergerstr. 27
80689 München GERMANY
Manufacturer responsible for batch release: CZ Veterinaria S.A.
Poligono La Relva, Torneiros s/n 36410 Porriño (Pontevedra) SPAIN
Coliprotec F4 lyophilisate for oral suspension for pigs
no
Each dose of vaccine contains:
Live non-pathogenic Escherichia coli O8:K87 (F4ac)1............................1.3x 108 to 9.0 x108 CFU2/dose
not attenuated
CFU = colony forming units White or whitish lyophilisate.
Medicinal
For active immunisation of pigs 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.
None.
A transient reduced weight gain was observed during the first week after vaccination in studies. Shivering was very commonly observed after vaccination in studies.
authorised
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).
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.
Pigs
Oral use and in drinking water use.
no
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.
Vaccination schedule: administer a single dose orally from 18 days of age.
Medicinal
The reconstituted vaccine is transparent to opaque white-yellowish suspension depending on the volume of water used for dilution.
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 driniking 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.
authorised
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 lL | 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.
no
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/litre.
Zero days.
Medicinal
Keep out of the sight and reach of children. Store and transport refrigerated (2 C – 8 C). Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Shelf-life after dilution according to directions: 4 hours.
Special warnings for each target species: Vaccinate healthy animals only.
Do not vaccinate animals undergoing immunosuppressive treatment. Do no vaccinate animals undergoing antibacterial treatment effective against Escherichia coli.
Special precautions for use in animals:
Apply the usual aseptic precautions to all administration procedures.
authorised
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 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.
Pregnancy and lactation:
The use is not recommended 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. 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.
no
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions other than those stated for single dose use have been observed after administration of 10 times the recommended dose
Incompatibilities:
Do not mix with any other veterinary medicinal product.
Medicinal
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this product is available on the website of the European Medicines Agency ().
Pack sizes:
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.
Medicinal
no
authorised
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.