Introduction

Company name: Elanco Animal Health

Address: Eli Lilly and Company Limited

Lilly House

Priestley Road, Basingstoke

Hampshire, RG24 9NL

Telephone: 01256 353131

Fax: 01256 779510

Email: elanco.uk.info@lilly.com

Website: www.elanco.com

Presentation

Pulmotil AC is a concentrate for oral solution for inclusion in the drinking water of chickens.

Each 1 ml of Pulmotil AC contains tilmicosin, as the phosphate, equivalent to 250 mg tilmicosin activity.

Uses

For the treatment of respiratory infections in chicken and turkey flocks associated with Mycoplasma gallisepticum and Mycoplasma synoviae. In vitro activity has been shown against Ornithobacerium rhinotracheale.

Dosage and administration

Important: Must be diluted before administration to chickens or turkeys.

To be included in the drinking water at 75 mg tilmicosin per litre (30 ml Pulmotil AC per 100 litres) for 3 days. Depending upon the age of the bird, this usually equates to a daily dose of 10-25 mg/kg bodyweight in chickens and 6-30 mg/kg bodyweight in turkeys.

One 240 ml bottle of Pulmotil AC is sufficient to medicate 800 litres of drinking water for chickens or turkeys.

A dose measure, with 10 and 20 ml calibrations, is provided with each bottle of Pulmotil AC.

Medicated drinking water should be prepared fresh every 24 hours using only clean water, according to the following dilution table:

Quantity of Pulmotil AC to be added	Drinking Water
	Litres	Gallons
5 ml (1 teaspoonful)	17	3.7
10 ml (lower cap measure)	33	7.3
15 ml	50	11
20 ml (upper cap measure)	67	15
30 ml	100	22
60 ml	200	44
240 ml bottle	800	176

Contra-indications, warnings, etc

For animal treatment only.

Not to be used in laying hens, where eggs are to be used for human consumption.

Accidental ingestion by humans should be avoided.

For oral use only. Pulmotil AC may be highly toxic when administered parenterally and, therefore, should not be injected.

The safety of tilmicosin has not been established in animals used for breeding purposes.

Do not allow horses or other equines access to drinking water containing tilmicosin.

KEEP OUT OF THE REACH OF CHILDREN.

Operator warnings

May cause irritation or sensitisation by skin contact. Avoid direct skin contact. Wear overalls and impervious gloves when mixing and handling the product. Wash affected parts if skin contact occurs. Avoid contact with eyes. If accidental eye contact occurs, immediately rinse thoroughly with water.

Withdrawal period

Turkey tissues 15 days. Chicken tissues 12 days.

Manure from treated animals should not be deposited on the same field in successive years.

Pharmaceutical precautions

Shelf-life of the unopened bottle - 2 years

Shelf-life of the opened bottle - 3 months

Store at or below 30°C. Protect from direct sunlight.

Dispose of empty bottles in accordance with National Legislation for waste disposal.

Legal category

POM-V

Packaging Quantities

Pulmotil AC is supplied in amber-coloured plastic bottles constructed with the resin polyethylene naphthalate. The nominal fill volume of the bottle is 240 ml.

Further information

None.

Marketing authorisation number

Vm 00006/4105.