Duramune DAP + L, Lyophilisate and diluent for suspension for injection for dogs

Provides protection against today’s most current field isolates of canine parvovirus (CPV-2b), stimulating higher levels of parvovirus SN antibodies. The vaccine also provides protection against canine distemper, adenovirus type 2 and Leptospira icterohaemorrhagiae and canicola.
Duramune Lepto vaccines are developed using a unique subunit manufacturing technique to separate out the Outer Membrane Complex, eliminating unnecessary cellular debris, and leaving the remaining purified surface immunogens to produce the vaccine.
Duramune Lepto vaccines are developed using a unique subunit manufacturing technique to separate out the Outer Membrane Complex, eliminating unnecessary cellular debris, and leaving the remaining purified surface immunogens to produce the vaccine.
Duramune is better tolerated than older broad spectrum canine vaccines and its primary vaccination can be completed at 10 weeks of age, facilitating earlier socialization.

Description

Duramune DAP + L is a combination vaccine presented as a lyophilisate and diluent for suspension for injection for dogs.
Each dose comprises:

Freeze-dried fraction Active substances:	Per 1 ml dose
Canine distemper virus, strain Onderstepoort	10^2.5 to 10^4.8 TCID₅₀*
Canine adenovirus type 2, strain V197	10^4.8 to 10^7.0 TCID₅₀*
Canine parvovirus, strain SAH	10^4.7 to 10^6.5 TCID₅₀*
*TCID₅₀ = tissue culture 50% infective dose
Liquid diluent fraction Active substances:	Per 1 ml dose
Inactivated Leptospira interrogans bacteria (outer membrane coat)
Serogroup canicola, Serovar canicola	Potency according to Ph.Eur.*
Serogroup icterohaemorrhagiae, serovar icterohaemorrhagiea	Potency according to Ph.Eur.*
Adjuvants:
Ethylene/Maleic anhydride (EMA)	0.01 ml
Neocryl XK-62 (50% solution)	0.03 ml
* hamster 80% protective dose according to Ph.Eur.

INDICATIONS

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

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 the leptospira fractions.

CONTRAINDICATIONS

Do not use in pregnant or lactating bitches.

ADVERSE REACTIONS

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 to 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.
Overdose
Some puppies may exhibit a transient lethargy by 4 hours post vaccination but recover by two days post vaccination. A small visible swelling (<5 cm) may very commonly be seen at the injection site, which may last for up to 17 days. Transient mild hyperthermia lasting not more than 24 hours may very commonly be seen in dogs given an overdose.

TARGET SPECIES

Dogs.

DOSAGE, ROUTE AND METHOD OF 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
Puppies 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.
Puppies 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 leptospiral antigens should be assured by administering a suitable L. icterohaemorrhagiae and L. canicola 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.

WITHDRAWAL PERIOD

Not applicable.

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 15 months.
Use immediately after reconstitution of the freeze-dried vaccine.

SPECIAL STORAGE PRECAUTIONS

Store and transport refrigerated (2^oC - 8^oC).
Do not freeze.
Protect from light.

SPECIAL WARNINGS

Only healthy dogs should be vaccinated.
Do not use in pregnant or lactating bitches.
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.
Do not mix with any other vaccine or immunological product except the diluent vaccine supplied.
The live vaccine strains of canine adenovirus type 2 (strain V197) and canine parvovirus (strain SAH) may spread to unvaccinated animals, but do not cause disease.
Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Dispose of waste materials by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

OTHER INFORMATION

ATCv code: QI07AI03
Nature and composition of immediate packaging
Freeze-dried Fraction: Vial: Type I (Ph.Eur.) glass. 3 ml capacity
Closure: Type I (Ph.Eur.) grey or red bromobutyl rubber stoppers sealed with aluminium crimp caps
Liquid diluent Fraction
Vial: High-density polypropylene.
Contents: 1 ml in a 3 ml injection vial.
Closure: Chlorobutyl snap-on rubber stoppers with centre hole caps sealed with aluminium crimp caps.
Pack sizes: Packs with 10 or 25 x 1 ml doses. Each dose is a combination of one vial of the freeze-dried fraction and one vial of diluent fraction.

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