Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Duramune DAPPi + LC
Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Presentation
Duramune DAPPi + LC is a combination vaccine presented as a lyophilisate and diluent 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 104.8 TCID50); canine adenovirus type 2, strain V197 (104.8 to 107.0 TCID50); canine parvovirus, strain SAH (104.7 to 106.5 TCID50) and canine parainfluenza virus (105.1 to 107.4 TCID50); and one vial of liquid diluent fraction, an inactivated adjuvanted suspension of canine coronavirus, strain TN449 (RP 1.0-2.0), Leptospira canicola outer membrane coat protein (potency as per Ph.Eur) and Leptospira icterohaemorrhagiae outer membrane coat protein (potency as per Ph.Eur).
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 interrogans serogroups canicola and icterohaemorrhagiae; to reduce clinical signs and infection caused by canine adenovirus 2; to reduce clinical signs and shedding caused by canine parainfluenza virus 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 three years for the canine distemper virus, canine adenovirus and canine parvovirus fractions and at least one year for all other antigens. After one year, only a reduction of oculo-nasal discharge has been demonstrated following canine parainfluenza challenge.
Demonstration of onset and of one year duration of immunity against canine parvovirus was conducted by challenge studies using virulent CPV2a and CPV2b. Demonstration of three years duration of immunity against canine parvovirus was conducted by challenge study using virulent CPV2b only.
Dosage and administration
The vaccine is to be administered by subcutaneous injection to dogs aged 6 weeks and above.
Aseptically reconstitute the contents of the freeze-dried fraction using the contents of the vial of liquid diluent fraction. Shake the vial well 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
Administer a single dose by subcutaneous injection one year after completion of the primary vaccination schedule. Subsequent booster vaccinations should be administered at intervals of not less than one year and not more than three years. If intervals longer than one year are implemented, immunity against the canine parainfluenza virus, leptospiral antigens and canine coronavirus should be assured by administering a suitable combined canine parainfluenza, L. icterohaemorrhagiae, L. canicola and canine coronavirus vaccine at intervals of not more than one year.
Advice on correct administration
Sterile needles and syringes should be used for administration.
Syringes and needles should not have been sterilised chemically or be above ambient temperature. Do not use chemicals to disinfect or sterilise skin. Shake well before use. Aseptic precautions should be observed. Reconstituted vaccine should be used immediately.
Contra-indications, warnings, etc
FOR ANIMAL TREATMENT ONLY
Do not use in pregnant or lactating bitches.
Following the first vaccination, it is very common for puppies to develop a small visible swelling (<2 cm) lasting for generally only two days. Following the second vaccination, it is very common for a small visible swelling (up to 5 cm) to 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.
In very rare cases, type I hypersensitivity reactions (facial oedema, urticaria, anaphylactic reaction), vomiting and diarrhoea may be observed after vaccination. In the event of an allergic or anaphylactic reaction, immediate appropriate symptomatic treatment should be given.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Only healthy dogs should be vaccinated. The vaccine may not be effective in dogs incubating the disease at the time of vaccination.
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 vaccine should be administered within 14 days before or after vaccination with this product.
Animals that have received immunosuppressive drugs (eg glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.
The live virus strains present in the vaccine may spread to unvaccinated animals, but do not cause disease.
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.
Withdrawal period
Not applicable.
Pharmaceutical precautions
Store and transport refrigerated (+2°C to +8°C). Do not freeze. Protect from light.
Do not use after the expiration date shown on the vial labels.
Keep out of reach and sight 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 diluent fraction.
Not all pack sizes may be marketed.
Further information
Disposal
Dispose of waste materials by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.
Marketing authorisation number
Vm 01596/4282.
Significant Changes
Duration of immunity | 20/08/2007 |