Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Duramune® DAPPi + L is a combination vaccine comprising: one vial of a freeze dried fraction containing live attenuated strains of canine distemper virus, strain Onderstepoort, (102.5 to 104.8 TCID50); canine adenovirus, type 2, strain V197 (104.8 to 107.0 TCID50); canine parainfluenza virus, strain FDL (104.6 to 107.4 TCID50); canine parvovirus, strain SAH (104.7 to 106.5 TCID50) grown on tissue culture.

One vial of liquid diluent fraction, an inactivated suspension of Leptospira canicola outer membrane coat protein (potency as per Ph.Eur) and Leptospira icterohaemorrhagiae outer membrane coat protein (potency as per Ph.Eur). Adjuvants: Ethylene/Maleic anhydride (EMA) 0.01 ml and Neocryl XK-62 0.03 ml.

Uses

For the active immunisation of dogs to prevent mortality and disease caused by canine distemper virus and canine parvovirus, to prevent mortality and reduce clinical signs due to infectious canine hepatitis and Leptospira and to reduce clinical signs and infection caused by canine adenovirus 2 and to reduce shedding of canine parainfluenza virus.

The onset of immunity is from two weeks after the second vaccination. The duration of immunity is at least three years for the canine distemper virus, canine adenovirus and canine parvovirus fractions. The duration of immunity is at least one year for the leptospira fractions. The duration of immunity for the canine parainfluenza component is not known but may be less than a year.

Dosage and administration

The vaccine is to be administered subcutaneously to dogs of the age of 6 weeks and older.

Aseptically reconstitute the contents of the freeze-dried vial using the liquid vaccine. Shake well before use. The entire contents of the reconstituted vial should be administered as a single dose.

Primary Vaccination

Pups 6-10 weeks of age:

The initial vaccination course consists of two vaccinations. The first vaccination should be given between 6-8 weeks of age and the second vaccination should be given from 10 weeks of age.

Pups of at least 10 weeks of age:

Two vaccinations should be given with an interval of 2-4 weeks between doses.

Booster Vaccination

Year 1 Annual booster - one dose of Duramune® DAPPi + L

Year 4 Booster - one dose of Duramune® DAPPi + L

For continued protection against canine parainfluenza and Leptospira an annual booster vaccination with one dose of Duramune® DAPPi + L or Duramune® PPi + L is recommended. The duration of protection of the CPI component has not been determined and an annual booster may not be sufficient if exposure to a high risk environment is expected.

Advice on Correct Administration

Syringes and needles should not have been sterilised chemically or be above ambient temperature. Do not use chemicals to disinfect or sterilise skin. Avoid the introduction of contamination during use. Sterile needles and syringes should be used for administration. Aseptic precautions should be observed.

Contra-indications, warnings, etc

Do not use in pregnant or lactating bitches.

Only healthy dogs should be vaccinated.

The efficacy of the CDV, CPV and CAV components of the vaccine may be reduced due to maternal antibody interference. However, the vaccine has been proved to be of benefit against virulent challenge in the presence of maternal antibody levels to CDV, CAV and CPV that are likely to be encountered under field conditions. In situations where higher MDA levels are expected the vaccination protocol should be planned accordingly.

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 when used on the same day or at different times) has not been demonstrated.

Do not mix with any other vaccine or immunological product.

The live vaccine strains may spread to unvaccinated animals, but do not cause disease.

Adverse Reactions:

Following the first vaccination, up to 80% of puppies develop a small visible swelling (<2cm) lasting for generally only two days. Following the second vaccination, occasionally a small visible swelling (up to 5 cm) may be seen at the injection site, which may last for up to five days. The swelling may be painful for 1 to 2 days. In most cases, these small and transient injection site reactions resolve with no need for treatment.

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

Pharmaceutical precautions

Keep out of the reach and sight of children. Reconstituted vaccine should be used immediately. Store and transport at 2-8°C. Do not freeze. Protect from light.

Legal category

POM-V

Packaging Quantities

Packs with 10, 25, 50, or 100 x 1 ml doses. Each dose is a combination of one vial of freeze-dried fraction and one vial of liquid vaccine.

Not all pack sizes may be marketed.

Further information

Disposal:

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

Marketing authorisation number

Vm 01596/4316.