Vanguard 7 is presented as a Lyophilisate and solvent for solution for injection. The fractions are:

Vanguard DA2Pi: freeze-dried fraction containing live attenuated canine distemper virus, N-CDV strain ≥ 103.0 CCID50, live attenuated canine adenovirus Type 2, Manhattan strain ≥ 103.2 CCID50 and live attenuated parainfluenzavirus, NL-CPI-5 strain ≥ 106.0 CCID50.

Vanguard CPV-L: liquid fraction containing live attenuated canine parvovirus, NL-35-D strain, low passage ≥ 107.0 CCID50, inactivated Leptospira canicola (between 420 and 740 RU (Relative Units)) and inactivated Leptospira icterohaemorrhagiae (between 463 and 915 RU).

CCID50 – 50% cell culture infectious dose

For the active immunisation of healthy puppies and 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 L. icterohaemorrhagiae, and to reduce pathological signs of disease caused by canine parainfluenzavirus 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.

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 sterilized syringes or needles, as these will interfere with the effectiveness of the vaccine.

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.

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

If protection against rabies is required:

First dose: Vanguard 7 from 10 weeks of age.

Second dose: Vanguard Lepto-ci mixed with Versiguard Rabies at least 14 days later, but not before 12 weeks of age.

To mix both products, Vanguard vaccines should be reconstituted as described above. The reconstituted vial will then be well shaken and then mixed with 1 ml of Versiguard Rabies either in the Versiguard Rabies vial or the syringe. Versiguard Rabies will be well shaken before use. The mixed vaccines will be gently shaken and then administered immediately by subcutaneous injection.

The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. However, in field studies 10% of seronegative dogs did not show seroconversion (>0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies. Some animals may also not show titres >0.5 IU/ml after the primary vaccination. Antibody titres drop over the course of the 3-year duration of immunity, although dogs are protected when challenged. In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥0.5 IU/ml).

Although the efficacy of the rabies fraction has been demonstrated following administration at 12 weeks, at the discretion of the veterinary surgeon, in case of need, dogs younger than 10 weeks can be vaccinated with Vanguard 7 mixed with Versiguard Rabies as the safety of this association has been demonstrated in 7-week-old dogs.

A single dose of Vanguard 7 should be given annually.

See Further Information section for more detailed guidance relating to duration of immunity.

Vaccinate healthy animals only.

Do not use during pregnancy.

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.

In very rare cases, vaccinated dogs may have a transient swelling 4-6 hours after vaccination which resolves after approximately 7 days.

In very rare cases, anaphylactic reaction occurs (e.g. circulatory shock/hypotension, loss of consciousness/collapse, pale mucous membrane, vomiting) may occur. If such reaction occurs, appropriate treatment (adrenaline or an equivalent) should be administered without delay.

Anorexia and ataxia have been reported very rarely.

The frequency of adverse reactions is defined using the following convention:

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 (e.g. vomiting) administer adrenaline or an equivalent.

Safety and efficacy data demonstrate that this vaccine can be administered subcutaneously in dogs on the same day as Versiguard Rabies either mixed or at different sites. The duration of immunity for Vanguard 7 when used with Versiguard Rabies has not been established.

After concurrent or mixed administration of Versiguard Rabies and Vanguard 7, vaccinated dogs may have a transient swelling (up to 6 cm) at the injection site and a transient swelling of the sub-mandibular and/or pre-scapular lymph nodes at the injection site 4 hours after vaccination. These signs resolve within 24 hours.

Do not mix with any other veterinary medicinal product, except Versiguard Rabies.

In case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical advice immediately and show the package leaflet or the label to the physician.

Store and transport refrigerated (2°C - 8°C). Do not freeze.

Shelf life after reconstitution according to directions: use immediately.

For animal treatment only.

Keep out of sight and reach of children.

Packs contain 25 vials of the Vanguard DA2Pi freeze-dried fraction and 25 vials of Vanguard CPV-L liquid fraction. Packs of disposable syringes with needles are also available.

Annual booster vaccination is recommended. However, should Veterinary Surgeons conduct a risk-benefit analysis for individual animals to determine the frequency of revaccination with Vanguard 7, they should be aware of the following information. Serological data has indicated that most dogs, when given at least the first annual booster, can maintain protective levels of immunity to the viral components of Vanguard 7 for up to 4 years. For further information please contact the company.

The CAV-2 strain used in Vanguard 7 has not been associated in either laboratory or field studies with corneal opacity (”blue eye”) or uveitis associated with adenovirus type 1 (CAV-1).

Canine parvovirus disease in kennels and pet shops is a problem of intensive husbandry and must be treated as such. Without careful professional attention to management practices in such places, successful disease control may be difficult to achieve.

When used in accordance with the recommended vaccination regime, Vanguard 7 can aid in the reduction of environmental contamination with canine parvovirus.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.