Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Inactivated, adjuvanted vaccine containing Mycoplasma hyopneumoniae, strain P-5722-3, RP* 1-1.9 and Haemophilus parasuis serotype 4, strain 2170B, RP* 1-8.1 and serotype 5, strain IA84-29755, RP* 1-3.4 per 2 ml dose. Also contains Carbopol 941 as adjuvant, thiomersal as preservative and amaranth as a colourant.

*Relative potency as compared to a reference in an in-vitro ELISA assay.

Semi-transparent, homogeneous, pale red solution.

Uses

For the active immunisation of pigs to reduce lung lesions caused by Mycoplasma hyopneumoniae and to reduce lesions and clinical signs caused by Haemophilus parasuis serotypes 4 and 5.

Onset of immunity against Mycoplasma hyopneumoniae has been demonstrated one week after second vaccination.

Onset of immunity against Haemophilus parasuis serotypes 4 and 5 has been demonstrated 3.5 weeks after second vaccination.

Duration of immunity studies indicate that the vaccine protects for 6 months after the second vaccination against Mycoplasma hyopneumoniae and Haemophilus parasuis serotypes 4 and 5.

Dosage and administration

The vaccine should be shaken well before use.

Administer a 2.0 ml dose by intramuscular injection only. Second vaccination should be administered preferably at the alternate side of the neck.

Vaccination schedule:

Pigs can be vaccinated from the age of 7 days and older. A second vaccination should be given 14-21 days later.

Advice on correct administration:

It is good practice to allow vaccine to warm to body temperature in the hand or pocket before administration, to avoid the discomfort of injection of a cold liquid.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Adverse Reactions:

Vaccinated animals may commonly experience a mild injection site reaction (up to 3.7 cm in diameter) which resolves within 5 days. In rare occasions, injection site reactions of more than 5 cm in diameter may be observed. Vaccinated animals may commonly have a mild, transitory hyperthermia which returns to normal within 24 hours. In rare occasions hyperthermia can be observed for a longer period of time.

In very rare cases, anaphylactic reactions may be observed after vaccination.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Special warnings:

The efficacy of the H.parasuis components of the vaccine may be reduced due to maternal antibody (MDA) interference. Field studies have shown that maternal antibody titres to H.parasuis have dropped significantly in most cases by 3 weeks of age.

No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either on the same day or at different times) has not been demonstrated.

Only healthy animals should be vaccinated.

Feeder-finishing pigs should preferably be vaccinated before the age of 10 weeks when the pigs are most susceptible.

Susceptible breeding animals should be vaccinated with two doses given 2 to 3 weeks apart, prior to introduction into a herd.

Do not use during pregnancy or lactation.

After administration with a double dose, reactions in pigs are similar to those seen after administration of a single dose but may persist for longer (up to 11 days), and injection site reactions may be larger (in rare occasions over 5 cm in diameter).

Do not mix with any other vaccine or immunological product.

Prior to first time use on a farm, it is strongly recommended that the advice of a veterinary practitioner is sought.

In the case of accidental self-injection, seek medical advice and show the package insert or the label to the physician.

Withdrawal Period: Zero days.

Pharmaceutical precautions

Keep out of the reach and sight of children. Store and transport refrigerated at +2°C to +8°C. Do not freeze. Store protected from light in the original container.

Shelf-life after first opening: Use immediately.

Legal category

POM-V

Packaging Quantities

Box with 1 or 10 high density polyethylene vials:

containers: 25 ml vial containing 10 doses; 60 ml vial containing 25 doses; 120 ml vial containing 50 doses; 250 ml vial containing 125 doses.

Box with 1 or 10 low density polyethylene sachets:

100 ml sachet containing 50 doses.

Not all pack sizes may be marketed.

Further information

Disposal:

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.

Marketing Authorisation Number

Vm 01596/4244