Vanguard^® Plus DHPPi/L4R

Vaccine

VANGUARD^® PLUS DHPPi/L4R is for the active immunisation of dogs from 8 – 9 weeks of age:

• to prevent mortality and clinical signs caused by canine distemper virus.
• to prevent mortality and clinical signs caused by canine adenovirus type 1.
• to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2.
• to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus.
• to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus.
• to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava.
• to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
• to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa and to prevent mortality, clinical signs and infection caused by rabies virus.

Do not use with other veterinary medicinal products. Rabies disease is a controlled disease in terms of the Animal Diseases Act (Act 35/1984). The occurrence or suspicion of the disease thus must be reported to the State Veterinary Services. A good immune response is reliant on a fully competent immune system. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

Immunological responses to the CDV, CAV and CPV components of the vaccine may be delayed due to maternally derived antibody interference. However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CDV, CAV and CPV at levels equal or higher to those likely to be encountered under field conditions. In situations where very high maternally derived antibody levels are expected, the vaccination protocol should be carefully planned accordingly.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use during pregnancy and lactation.

A transient swelling may be observed at the injection site following subcutaneous administration in dogs. Gastrointestinal signs such as diarrhoea and vomiting or anorexia and decreased activity are possible. Hypersensitivity reactions (i.e. anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur. Keep out of reach of children, uninformed persons and animals. Although this product has been extensively tested under a large variety of conditions, failure thereof may ensue because of a wide range of reasons. If this is suspected, notify the registration holder.

Precautions for use in animals: Only healthy animals should be vaccinated.

Do not use in animals that are showing signs of rabies or that are suspected of being infected with rabies virus. The live attenuated virus vaccine strains CAV-2, CPiV and CPV-2b may be shed by vaccinated animals following vaccination, shedding of CPV has been shown for up to 10 days. However, due to the low pathogenicity of these strains, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs. The vaccine virus strain CPV-2b has not been tested in domestic cats and other carnivores (except dogs) that are known to be susceptible to canine parvoviruses. Therefore, vaccinated dogs should be separated from other canine and feline species after vaccination.

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 any vaccine containers, unused vaccine and disposable vaccine equipment in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).

Use only as directed. Subcutaneous use.

Aseptically reconstitute the lyophilisate with the solvent. Shake well and administer immediately the entire content (1 ml) of the reconstituted product.

Reconstituted vaccine: pink/red, or yellowish colour with slight opalescence.

Primary vaccination scheme:

Two doses of VANGUARD® PLUS DHPPi/L4R 3 – 4 weeks apart from 8 – 9 weeks of age.

The second dose should not be given before 12 weeks of age.

Rabies:

The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. Therefore, the first dose may be given using VANGUARD® PLUS DHPPi/L4. In this case the second vaccination with VANGUARD® PLUS DHPPi/ L4R should not be given before 12 weeks.

However, in field studies 10 % of sero-negative dogs did not show seroconversion (> 0,1 IU/ml) 3 – 4 weeks after single primary vaccination against rabies. Another 17 % did not show the 0,5 IU/ml rabies antibody titre required by some non-EU countries to travel in. In case of travelling to risk areas or for travel outside the EU veterinary surgeons may wish to use a two-dose primary course including rabies or give an additional rabies vaccination after 12 weeks.

In case of need, dogs of 6 weeks old can be vaccinated as safety of this product has been demonstrated in 6 weeks old dogs.

Re‑vaccination scheme:

A single dose of VANGUARD® PLUS DHPPi/L4R should be given every 3 years.

Store in a cool place between 2 °C and 7 °C. Do not freeze. Protect from light.

Plastic box containing 25 vials of lyphilisate and 25 vials of solvent.