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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 viral shedding of 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.
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Presentation
Duramune DAPPi + LC 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 (103.6 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 Canine coronavirus, strain TN449 (RP of 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 active immunization 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; to reduce viral shedding of 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 one year for all antigens except the canine parainfluenza component which is not known but may be less than a year.
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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 DAPPi + LC 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.
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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 all cases these small and transient injection site reactions resolve with no need for treatment. Avoid the introduction of contamination during use.
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.
Reconstituted vaccine should be used immediately.
Shake well before use.
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 the CDV, CPV and CAV components of the vaccine may be reduced 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.
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. This product should not be used concurrently or simultaneously with any other immunological 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.
Keep out of reach of children.
Pharmaceutical precautions
Store at +2°C to +8°C. Do not freeze. Protect from light.
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Legal category
POM-V (previously POM).
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 the liquid diluent fraction.
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 01596/4282.
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