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Date: Wednesday, May 22, 2024 20:58

Release 6.246
Enterisol Ileitis lyophilisate and solvent for oral suspension for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Enterisol® Ileitis lyophilisate and solvent for oral suspension for pigs
Product index: Enterisol Ileitis
Pig - meat: Zero days
Incorporating:
Presentation
Lyophilisate and solvent for oral suspension. Lyophilisate: light yellow to gold. Solvent: clear, colourless solution.
Each dose (2 ml) contains:
Lyophilisate:
Active substance:
Live attenuated Lawsonia intracellularis (MS B3903): 10 4.9 - 10 6.1 TCID50*
*Tissue Culture Infective Dose 50%
Uses
For active immunisation of weaned pigs from 3 weeks of age and older to reduce the intestinal lesions caused by Lawsonia intracellularis infection and to reduce growth variability and loss of weight gain associated with the disease.
Under field conditions, the difference in average daily weight gain was seen to be up to 30 g/day when vaccinated pigs were compared to unvaccinated pigs.
Onset of immunity: as early as 3 weeks post vaccination.
Duration of immunity: for at least 17 weeks.
Dosage and administration
All materials used in administering the vaccine must be free of antimicrobials, detergent or disinfectant residues to prevent inactivation.
Reconstitution with solvent:
10 and 50 dose presentations: Reconstitute the vaccine by adding the full contents of the accompanying solvent to the vaccine. Shake well and use immediately.
100 dose presentation: Reconstitute the vaccine by adding half of the contents of the accompanying solvent to the vaccine. Shake well and transfer the suspension back into the solvent bottle, mix with the remaining solvent to complete to a total volume of 200 ml. Shake well and use immediately.
Visual appearance after reconstitution: light orange to pink semi-transparent suspension.
Vaccination by drench application:
Administer a single 2 ml dose orally to pigs (from 3 weeks of age), irrespective of body weight.
Vaccination via the drinking water:
The systems have to be cleaned and intensively rinsed with untreated water to avoid any residues of antimicrobials, detergents or disinfectants.
The final solution containing the vaccine should be consumed within 4 hours after preparation. Calculate the number of vials required to vaccinate all the pigs according to the table below:
No of Pigs
Vaccine vial
Solvent Vial
10
10 dose (20ml)
20ml
50
50 dose (100ml)
100ml
100
100 dose (100ml)
200ml
Dilute the reconstituted vaccine in drinking water on the basis of pre-measured water intake during a 4 hour time period of the previous day at the time of planned vaccination.
Pigs will generally drink 8 to 12 % of their body weight per day, depending on environmental temperatures. The actual amount of water consumed may vary considerably depending on several factors. It is essential for the efficacy of the product that pigs receive at least the recommended dose. Therefore it is recommended to assess the actual water intake over the 4 hour period the day before vaccination at same time the vaccination is planned to occur.
In case of vaccination using a trough the total water uptake within 4 hours needs to be provided. In case of vaccination via proportioner the required volume of stock solution for a 4 hours vaccination needs to be measured.
It is recommended to add skimmed milk powder or sodium thiosulfate solution as a stabilizer into the drinking water prior to adding the vaccine. The final concentration of the skimmed milk powder should be 2.5 g/litre. The final concentration of sodium thiosulfate should be approximately 0.055 g/litre.
After measuring the calculated water amount, sodium thiosulphate or skimmed milk powder should be added to the water. Afterwards, the reconstituted vaccine is to be diluted either in the water / skimmed milk or in the water / thiosulphate mixture in the trough.
Ensure that the reconstituted vaccine is evenly distributed in the water. Once even distribution has been achieved, fill the trough or the proportioner.
Vaccination via liquid feed:
The feeding systems and mixing device must be cleaned to avoid residues of antimicrobials, detergents or disinfectants.
Calculate the required number of vaccine vials as indicated in the table above.
Determine the amount of feed the animals will consume during one feeding session in less than 4 hours. The amount of feed should be defined by the feed uptake of the previous day, at the same feeding session for which the vaccination is planned.
Prepare liquid feed freshly with drinking water. The use of feed with controlled fermentation or feed containing formaldehyde is not recommended for vaccination as vaccine stability for these feed types was not tested. Reconstitute the vaccine using the provided solvent. Add the reconstituted vaccine to the fully prepared liquid feed.
Alternatively, to facilitate homogenous mixing the reconstituted vaccine may be further diluted to obtain a larger volume. This must be done with fresh drinking water containing 2.5 g/litre skimmed milk powder or 0.055 g/litre sodium thiosulfate and then mixed with the liquid feed. Ensure that the reconstituted vaccine is evenly distributed into the feed.
Contra-indications, warnings, etc
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
The vaccine has not been tested in breeding boars. Therefore, the vaccination of breeding boars is not recommended.
Do not vaccinate animals which are receiving treatment with antimicrobials effective against Lawsonia spp. Such antimicrobials should be withheld for a minimum of 3 days before and 3 days after the day of vaccination.
Efficacy of revaccination is unknown.
Special precautions for use
Special precautions for use in animals.
In case of anaphylactic reactions, appropriate symptomatic treatment including the administration of glucocorticoids, adrenaline, or antihistamines is recommended.
The vaccine is an attenuated live vaccine and the potential for spreading to non-vaccinated animals cannot be excluded. However, based on the studies conducted with sentinel pigs, the apparent frequency of spreading and associated risk is very low. Lawsonia intracellularis DNA could be detected up to 3 days post vaccination in faecal samples of more than half of vaccinated animals, therefore transmission to pen-mates cannot be excluded in this time period.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid accidental contact with the skin. In the event of accidental skin contact, wash with soap or antibacterial wash and rinse well.
Adverse reactions
None known.
Use during pregnancy, lactation or lay
No adverse reaction was observed after administration of the vaccine in breeding and pregnant animals.
Interaction with other medicinal products and other forms of interaction
Since the vaccine isolate is a live bacterium, simultaneous use of antimicrobials which are effective against Lawsonia spp. should be avoided for a minimum of 3 days before and after vaccination.
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
No adverse reactions have been observed following administration of 10 times the recommended dose.
Withdrawal period
Zero days.
Pharmaceutical precautions
Shelf-life of the vaccine lyophilisate as packaged for sale: 2 years
Shelf-life after reconstitution according to directions: 4 hours
Store and transport refrigerated (2°C - 8°C).
Do not freeze. Protect from light.
Keep out the sight and reach of children. For animal treatment only.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Lyophilisate:
Type 1 amber glass vial of 20 ml (10 doses), 100 ml (50 doses) and 100 ml (100 doses) closed with a bromobutyl stopper with lacquered aluminium seal.
Solvent:
High density polyethylene vial containing 20 ml, 100 ml and, 200 ml closed with a chlorobutyl stopper with lacquered aluminium seal.
Cardboard box of 1 lyophilisate vial of 20 ml (10 doses) and 1 solvent vial of 20 ml. Cardboard box of 1 lyophilisate vial of 100 ml (50 doses) and 1 solvent vial of 100 ml. Cardboard box of 1 lyophilisate vial of 100 ml (100 doses) and 1 solvent vial of 200 ml. Cardboard box of 12 lyophilisate vials of 100 ml (100 doses) and 12 solvent vials of 200 ml. Corresponding vials of lyophilisate and solvent are packed together in one cardboard box.
Not all package sizes may be marketed.
Further information
Pharmacotherapeutic group: immunologicals for Suidae, live bacterial vaccines for pigs, Lawsonia
ATCvet code: QI09AE04
The vaccine is designed to stimulate the development of an active immune response to Lawsonia intracellularis in pigs. Seroconversion following vaccination cannot usually be detected, and is not related to protection.
The vaccine modulates the composition of the microbiome. Published literature suggests that this can reduce the Salmonella spp. prevalence in the acute phase of the infection and the seroprevalence at slaughter in L. intracellularis and Salmonella enterica co-infected pigs.
Marketing Authorisation Number
Vm 08327/4294
Significant changes
GTIN
GTIN description:Enterisol Ileitis lyophilisate and diluent for oral suspension for pigs - 20ml
GTIN:5012917046045
GTIN description:Enterisol Ileitis lyophilisate and diluent for oral suspension for pigs - 100ml
GTIN:5012917046038