Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Inactivated, Amphigen adjuvanted Mycoplasma hyopneumoniae vaccine.

An off-white emulsion for injection. Each 2ml dose of vaccine contains 4.5 to 5.2 log10 Relative Potency Units of inactivated Mycoplasma hyopneumoniae Strain NL1042, 0.025ml of Amphigen Base, and 0.075ml of Drakeol 5 (mineral oil).

Uses

For active immunisation of piglets from 7 days of age to reduce lung lesions related to infection by Mycoplasma hyopneumoniae in fattening pigs. The onset of immunity is within two weeks after vaccination. A duration of immunity of at least 25 weeks has been demonstrated.

In more detailed studies in piglets from three weeks of age, vaccination has also been shown to reduce coughing and losses in weight gain related to infection by Mycoplasma hyopneumoniae in fattening animals. In these studies, onset of immunity three weeks after vaccination and a duration of immunity of at least 23 weeks were demonstrated; periods shorter than three weeks of age or longer than 23 weeks were not tested.

Dosage and administration

Shake and aseptically administer a single 2ml injection by the deep intramuscular route in the lateral neck muscle.

Do not use chemically sterilized syringes and needles.

Vaccination Programme

One single dose of 2ml of vaccine should be given to piglets from 7 days of age. Vaccination should be performed prior to the period of risk. Infection usually occurs within the first month of life.

Contra-indications, warnings, etc

Do not vaccinate pregnant or lactating animals.

Hypersensitivity reactions, including shock and death may occur in very rare cases. Appropriate treatment (for example glucocorticoid intravenously or adrenaline intramuscularly) should be administered.

Administration of the vaccine may be followed by a mild, transient reaction at the injection site up to 2.5cm which resolves within two days (incidence 16%). Transient increases in rectal temperature can be observed for up to four days post vaccination.

As part of the immune reaction following vaccination, inflammatory cell infiltration and/or fibrosis may occur in the muscle tissue at the injection site, lasting for at least 14 days.

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

Injection site reactions observed after the administration of a single overdose are similar to those following a dose of vaccine. A percentage of animals (approximately 27%) vaccinated with an overdose may develop a palpable injection site reaction of up to 3cm in diameter that resolves within two days.

Withdrawal period

Zero days.

Operator Warning

To the user

This product contains mineral oil.

Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the doctor

This product contains mineral oil. Even if very small amounts have been injected, accidental injection with this oil-based product can cause intense swelling which may, for example, result in ischemic necrosis and the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Pharmaceutical precautions

Store away from light between +2°C and +8°C. Do not freeze. A slight black deposit may appear during storage. Stellamune Once has an in-use shelf life of 10 hours.

Avoid the introduction of contamination during use. Do not mix with any other vaccine/immunological products.

Any unused product or waste material should be disposed of in accordance with national requirements.

For animal treatment only.

Keep out of reach of children.