1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Enterisol Ileitis lyophilisate and diluent for oral suspension for pigs

Enterisol Ileitis vet. (DK, NO, SV) lyophilisate and diluent for oral suspension for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Attenuated live bacteria Lawsonia intracellularis (MS B3903).

One 2 ml dose of reconstituted vaccine contains:

Active substance:

Lawsonia intracellularis: At least: 1 x 10^4.9TCID₅₀*

Maximum: 1 x 10^6.1TCID₅₀*

*: Tissue Culture Infective Dose

Diluent:

Sterile water for oral administration: q.s. ad 2.0 ml

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and diluent for oral suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs (weaned pigs from 3 weeks of age).

4.2 Indications for use, specifying the target species

For active immunisation of pigs from 3 weeks of age and older to reduce the intestinal lesions caused by Lawsonia intracellularisinfection 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 protection occurs as early as 3 weeks post vaccination and lasts for at least 17 weeks.

4.3 Contraindications

None.

4.4 Special warnings

vaccine has not been tested in breeding boars, therefore do not vaccinate breeding boars.

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.

4.5 Special precautions for use

Special precautions for use in animals.

Vaccinate only clinically healthy animals.

In case of anaphylactic reactions, appropriate symptomatic treatment including the administration of glucocorticoids, adrenaline, or antihistaminics 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 can not 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.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

No adverse reaction was observed after administration of the vaccine in breeding and pregnant animals.

4.8 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.

4.9 Amounts to be administered and administration route

All materials used in administering the vaccine must be free of antimicrobials, detergent or disinfectant residues to prevent inactivation.

Reconstitution with diluent:

10 and 50 dose presentations: Reconstitute the vaccine by adding the full contents of the accompanying diluent to the vaccine. Shake well and use immediately.

100 dose presentation: Reconstitute the vaccine by adding half of the contents of the accompanying diluent to the vaccine. Shake well and transfer the suspension back into the diluent bottle, mix with the remaining diluent to complete to a total volume of 200 ml. Shake well and use immediately.

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:	Diluent vial:
10	10 dose (20 ml)	20 ml
50	50 dose (100 ml)	100 ml
100	100 dose (100 ml)	200 ml

Dilute the 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.

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 filling of the calculated water amount into the trough, sodium thiosulphate or skimmed milk powder should be added to the water. Afterwards, the vaccine is to be diluted either in the water / skimmed milk or in the water / thiosulphate mixture in the trough.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse reactions have been observed following administration of 10 times the recommended dose.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

The vaccine is designed to stimulate the development of an active immune response to Lawsonia intracellularis.

Seroconversion following vaccination cannot usually be detected, and is not related to protection.

ATC Vet code: QI09AE04 (Lawsoniavaccine)

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Gelatine

Potassium hydroxide

L-glutamic acid

Potassium dihydrogen phosphate

Dipotassium phosphate

Water for injections in bulk

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf-life of the medicinal product as packaged for sale: 2 years

Shelf-life after dilution or reconstitution according to directions: 4 hours

6.4 Special precautions for storage

Store and transport refrigerated (2 °C - 8 °C).

Do not freeze.

6.5 Nature and composition of immediate packaging

Vaccine lyophilisate:

Type 1 amber glass vial of 20 ml (10 doses), 100 ml (50, 100 doses) and 12 x 100 ml (12 x 100 doses) closed with a bromobutyl stopper with lacquered aluminium seal.

Vaccine diluent:

Type 1 clear glass vial containing 20 ml (10 doses), 100 ml (50 doses), 200 ml (100 doses) and 12 x 200 ml (12 x 100 doses) closed with a chlorobutyl stopper with lacquered aluminium seal.

High density polyethylene vial containing 20 ml (10 doses), 100 ml (50 doses), 200 ml (100 doses) and 12 x 200 ml (12 x 100 doses) closed with a chlorobutyl stopper with lacquered aluminium seal.

Not all package 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 product or waste material should be disposed of in accordance with national requirements.

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authority

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Ltd

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

8. MARKETING AUTHORISATION NUMBER

Vm 00015/4073

9. RENEWAL OF THE AUTHORISATION

23 March 2010

10. DATE OF REVISION OF THE TEXT

17 December 2009

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.