SUMMARY OF PRODUCT CHARACTERISTICS

Duramune DAPPi+LC Lyophilisate and Solvent for Suspension for Injection for Dogs.

1. Lyophilisate fraction:

Active Substances	Per 1 ml dose
Canine distemper virus, strain Onderstepoort	101.1 to 103.4 TCID50*
Canine adenovirus type 2, strain V197	104.0 to 106.2 TCID50*
Canine parvovirus, strain SAH	104.7 to 106.5 TCID50*
Canine parainfluenza virus, strain FDL	104.5 to 106.8 TCID50*

*TCID₅₀= tissue culture 50% infective dose

Excipients
For a full list of excipients, see section 6.1.

2. Liquid solvent 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 icterohaemorrhagiae	Potency according to Ph.Eur.*
Canine coronavirus, strain TN449 (inactivated)	RP* 1.0-2.0**
Adjuvants
Ethylene/Maleic anhydride (EMA-31)	0.1 mg
Neocryl	0.015 ml
Excipients
For a full list of excipients, see section 6.1.

* hamster 80% protective dose according to Ph.Eur.
** RP = Relative Potency

Lyophilisate and solvent for suspension for injection.

Lyophilisate: Cream-yellow colour powder

Solvent: opaque liquid.

Dogs

For active immunisation of dogs to prevent mortality and disease caused by canine distemper virus; to prevent mortality and disease andreduce virus shedding caused by canine parvovirus infection;to prevent mortality and reduce clinical signs caused by infectious canine hepatitis and Leptospira interrogans serogroups canicolaand icterohaemorrhagiae; and to reduce clinical signs and infection caused by canine adenovirus 2; to reduce clinical signs and shedding caused by infection with 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 and canine adenovirus components and at least one year for all other antigens.

The duration of immunity for the canine parvovirus component has been demonstrated to be at least three years following challenge with CPV2b. A duration of immunity of at least 1 year has been proven after CPV2a challenge. Duration of immunity against CPV2c has not been investigated. Demonstration of onset of immunity against canine parvovirus was conducted by challenge studies using virulent CPV2a and CPV2b following vaccination from 6 weeks of age and CPV2c following vaccination from 8 weeks of age.

After one year only a reduction of oculo-nasal discharge has been demonstrated following canine parainfluenza challenge.

Only vaccinate healthy dogs

None

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 proven to be of benefit in the presence of maternal antibody levels that are likely to be encountered under field conditions against virulent challenge by CDV, CAV and CPV (2a and 2b). Efficacy against CPV-2c in the presence of MDA has not been investigated. In situations where higher MDA levels are expected the vaccination protocol should be planned accordingly.

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

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

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, lethargy, 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.

In any animal population there will be a small number of individuals, which fail to respond fully to vaccination.

Do not use in pregnant or lactating bitches.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

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

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

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 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. For booster vaccinations against CPV the epidemiological situation should be taken into consideration.

Overdose (symptoms, emergency procedures, antidotes), if necessary

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

Not applicable.

To stimulate active immunity against canine distemper virus, canine adenovirus, infectious canine hepatitis, canine parainfluenza virus, canine parvovirus, canine coronavirus, Leptospira interrogans serogroup canicolaand Leptospira interrogans serogroup icterohaemorrhagiae.

ATC Code: QI07AJ10

1. Lyophilisate fraction:

Sucrose
Gelatin
Bactopeptone
Potassium phosphate dibasic
Potassium phosphate monobasic
Sodium hydroxide
Eagle’s Earle’s medium with HEPES

2. Liquid solvent fraction:

Ethylene/Maleic anhydride (EMA-31)

Neocryl

Sodium chloride
Sodium phosphate dibasic
Potassium phosphate monobasic
Water for injections

Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.

Shelf-life of the veterinary medicinal product as packaged for sale: 18 Months

Shelf-life after reconstitution according to directions: Use immediately.

Store and transport refrigerated (+2°C - +8°C).

Protect from light.
Do not freeze.

Lyophilisate Fraction

Vial: Type I (Ph.Eur.) glass.

Closure: Bromobutyl rubber stoppers sealed with aluminium caps.

Liquid solvent Fraction

Vial: Type I (Ph.Eur.) glass.

Closure: Chlorobutyl rubber stoppers sealed with aluminium caps.

Pack Sizes

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

Not all pack sizes may be marketed.

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

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm42058/4050

11 July 2002

October 2015

Approved: 30/10/2015