Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

Emulsion for injection for fattening pigs.

Inactivated whole culture of Mycoplasma hyopneumoniae, J strain, Isolate B-3745 grown in liquid medium.

One dose of two ml vaccine contains –

before inactivation : Min. antigen: 3.0 x 108 CCU*; max. antigen 6.0 x 108 CCU*

*: Colour Changing Units

after inactivation – Mycoplasma hyopneumoniae ≥ 1 : 80 antibody titre elicited with ½ dose (rabbits/ELISA assay)

Adjuvant : Montanide ISA 708 : 1.30ml (65%)

Uses

For active immunisation of pigs from three weeks of age to reduce lung lesions following infection with Mycoplasma hyopneumoniae. Onset of protection occurs by two weeks post vaccination and lasts for at least 118 days.

Dosage and administration

Warm to room temperature and shake well prior to use. The minimum needle diameter recommended is 1.2 mm. The vaccination dose is 2 ml, irrespective of body weight. A single dose should be administered by deep intramuscular injection in the neck to pigs of three to ten weeks of age. Avoid the introduction of contamination during use.

Contra-indications, warnings, etc

Depression and reduction of appetite may occur after administration. These symptoms generally disappear within a few days. Swellings of about two centimetres in diameter, which may be of hard consistency, may be observed at the site of injection in about 2.4% of the cases. These swellings will disappear within one to two days.

In very rare cases granulomatous reactions at the injection site have been observed at the slaughterhouse which are mainly caused by an improper injection technique.

Do not mix with any other vaccine/immunological product.

Vaccinate only clinically healthy animals.

In the case of anaphylactic reactions, the administration of epinephrine is recommended.

Do not use during pregnancy and lactation.

No information is available on the safety and efficacy of the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product.

Operator Warnings

Ensure that the method of restraint, handling and administration, e.g. by the use of guarded needles, minimises the risk of accidental injection/self injection.

In case of accidental self injection of vaccine, seek medical advice immediately and show the package leaflet to the physician.

Disposal Advice

Empty vaccine containers and any unused material shall be discarded according to national regulations.

Withdrawal period

Zero days.

Pharmaceutical precautions

Store and transport between +2°C and +8°C

Do not freeze.

Use immediately after opening

Keep out of reach and sight of children.

For veterinary prescription only

Legal category

POM-V

Packaging Quantities

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

Further information

Manufacturer:

Boehringer Ingelheim Vetmedica, Inc

St Joseph, Missouri, 64506-2002, USA

US Veterinary License No 124

Marketing authorisation number

Vm 00015/4067.