Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Duramune® Puppy DP+C is a combination vaccine presented as a lyophilisate and solvent for suspension for injection. Each dose comprises one vial of a freeze dried fraction containing live attenuated strains of canine distemper virus, strain Onderstepoort, (102.5 to 104.8TCID50); and canine parvovirus, strain SAH (104.7 to 106.5TCID50) and one vial of liquid diluent fraction, an inactivated suspension of canine coronavirus, strain TN449 (RP of 1.0-2.0).

Uses

For active immunisation of dogs to prevent mortality and reduce disease caused by canine distemper virus and canine parvovirus and to reduce infection at the intestinal level caused by canine coronavirus. The onset of immunity is from two weeks after the second vaccination. The duration of immunity is at least one year for all antigens.

Dosage and administration

Administer vaccine by subcutaneous injection.

Aseptically reconstitute the contents of the freeze-dried fraction using the liquid diluent fraction. Shake the vial and immediately administer all of the reconstituted vaccine using aseptic technique.

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

An annual booster vaccination with one dose of Duramune® Puppy DP+C is recommended.

Contra-indications, warnings, etc

Do not use in pregnant or lactating bitches.

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 1-2 days. In most cases these small and transient injection site reactions resolve with no need for treatment.

Syringes and needles should not have been sterilised chemically or be above ambient temperature. Do not use chemicals to disinfect or sterilise skin.

Reconstituted vaccine should be used immediately.

Shake well before use.

Avoid the introduction of contamination during use.

Sterile needles and syringes should be used for administration.

Aseptic precautions should be observed.

Only healthy dogs should be vaccinated.

The vaccine may not be effective in dogs incubating the disease at the time of vaccination.

The efficacy of CDV and CPV 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 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.

Withdrawal period: Not applicable.

In the event of an allergic or anaphylactic reaction, immediate treatment should be given with a soluble glucocorticoid intravenously (e.g. dexamethasone sodium phosphate).

No information is available on the effects of 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 this product.

Animals that have received the corresponding antiserum or immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.

Pharmaceutical precautions

Store and transport at +2ºC to +8ºC. Do not freeze. Protect from light. Do not use after the expiration date shown on the vial labels. Keep out of reach of children.

Legal category

POM-V

Packaging Quantities

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

Not all pack sizes may be marketed.

Further information

In any animal population there will be a small number of individuals, which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the animal’s ability to respond. Immune competence can be influenced by genetic factors, intercurrent infection, age, nutritional status, concurrent drug therapy, stress etc.

Disposal: Dispose of waste materials by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

Marketing authorisation number

Vm 01596/4317.

Significant Changes