SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Vanguard 7

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Quantity per 1 ml dose

Active substances:

Freeze-dried fraction: Vanguard DA₂Pi

Live attenuated canine distemper virus, strain N-CDV, minimum titre: 10^3.0 CCID₅₀*

Live attenuated canine adenovirus Type 2, strain Manhattan, minimum titre: 10^3.2 CCID₅₀*

Live attenuated canine parainfluenzavirus, strain NL-CPI-5, minimum titre: 10^6.0 CCID₅₀*

Liquid fraction: Vanguard CPV-L

Live attenuated canine Parvovirus, strain NL-35-D, low passage, minimum titre: 10^7.0 CCID₅₀*

Inactivated Leptospira canicola, at least 40 hamster protective doses

Inactivated Leptospira icterohaemorrhagiae, at least 40 hamster protective doses

*Cell culture infectious dose-50

See Section 6.1 for full list of excipients.

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for solution for injection

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

Active immunisation of dogs to prevent mortality and clinical signs due to canine distemper virus infections, to prevent clinical signs including leucopenia and reduce viral shedding caused by canine parvovirus (type 2a), to prevent mortality and clinical signs including leucopenia and reduce viral shedding caused by canine parvovirus (types 2b and 2c), to reduce mortality and clinical signs due to canine adenovirus type 1 infections, to reduce clinical signs and infection or excretion due to canine adenovirus type 2 infections, to reduce clinical signs and infection due to Leptospira canicola and icterohaemorrhagiae and, to reduce pathological signs of disease caused by canine parainfluenza virus infections.

Onset of immunity occurs by approximately two weeks after the last dose of the Basic Vaccination Scheme. Onset of immunity for the canine parvovirus component (type 2b) occurs 7 days after a single dose when animals are vaccinated from 9 weeks of age.

The duration of immunity for canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2 and the leptospiral components is at least 12 months. However, the duration of immunity for canine parainfluenzavirus has not been determined.

4.3 Contraindications

Do not use in unhealthy animals.

4.4 Special warnings for each target species

The canine adenovirus Type 2 and canine parvovirus vaccinal strains may be shed from vaccinated animals for a number of days following vaccination. However, due to the low pathogenicity of these strains, it is not necessary to keep vaccinated animals separated from non-vaccinated animals.

High levels of maternally derived antibodies (MDA) may interfere with the response to vaccination. Although the vaccine has been shown to be efficacious in the presence of levels of MDA that are likely to be encountered under field conditions, where for any reason it is likely that particularly high levels of MDA are present (for example against the CPV component), this should be taken into account when planning the timing of vaccinations.

4.5 Special precautions for use

None

In case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical attention showing a copy of the product literature.

4.6 Adverse reactions (frequency and seriousness)

Vaccinated dogs may have a transient swelling 4-6 hours after vaccination which resolves after approximately 7 days.

If a systemic anaphylactic reaction occurs (eg vomiting), administer adrenaline or an equivalent.

4.7 Use during pregnancy, lactation or lay

Do not use during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

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 decided on a case by case basis.

4.9 Amounts to be administered and administration route

Dosage and route of administration:

Reconstitute one vial of the freeze-dried fraction (Vanguard DA₂Pi) aseptically using the contents of one vial of the liquid fraction (Vanguard CPV-L) as diluent. Shake well and immediately inject the entire contents of the reconstituted vial (1 ml) subcutaneously. Do not use chemically sterilised syringes or needles, as these will interfere with the effectiveness of the vaccine.

Basic Vaccination Scheme:

Puppies younger than 10 weeks of age

Two doses of Vanguard 7 at least 14 days apart. The first dose can be given as young as 7 weeks of age. The second dose should not be given until at least 10 weeks of age.

Puppies 10 weeks of age and older

A single dose of Vanguard 7, followed by a single dose of Vanguard Lepto-ci at least 14 days later

Re-vaccination Scheme:

A single dose of Vanguard 7 to be given annually thereafter

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

Occasional transient swellings may occur at the injection site after vaccination with an overdose.

No treatment is necessary in most cases of overdose. However, if a systemic anaphylactic reaction occurs (eg vomiting), administer adrenaline or an equivalent.

4.11 Withdrawal period(s)

Not applicable.

5. IMMUNOLOGICAL PROPERTIES

The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine adenoviruses Types 1 and 2, canine parainfluenzavirus, canine parvovirus, Leptospira canicola and Leptospira icterohaemorrhagiae.

ATC Vet code:QI07AI02

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Neomycin

Gentamycin

6.2 Incompatibilities

Do not mix with any other vaccine or immunological product.

6.3 Shelf life

Shelf-life as packaged for sale:

For the freeze-dried fraction (Vanguard DA₂Pi): 2 years

For the liquid fraction (Vanguard CPV-L): 4 years

The vaccine should be administered immediately after reconstitution.

6.4. Special precautions for storage

Store and transport at +2°C to +8°C. Do not freeze.

6.5 Nature and composition of immediate packaging

The vaccine is filled in 1 dose vials glass Type I (Ph Eur). Vials of the freeze-dried fraction are closed with a bromobutyl rubber stopper and a varnished aluminium cap. Vials of the liquid fraction are closed with a chlorobutyl rubber stopper and a varnished aluminium cap.

Pack contains 1, 10, 25 or 100 vials of Vanguard™ DA₂Pi Lyophilisate fraction and 1, 10, 25 or 100 vials of 1 ml Vanguard™ CPV-L solvent fraction.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm: 42058/4157

9. DATE OF RENEWAL OF THE AUTHORISATION

Date: 28 October 2010

10. DATE OF REVISION OF THE TEXT

Date: February 2014

19 February 2014