Horses and ponies

Active immunisation of horses and ponies from 5 months of age for:

- Reduction of body temperature increase, coughing, inappetence, difficulty swallowing, and changes in demeanour in the acute stage of infection with Streptococcus equi.

- Reduction of number of abscesses within submandibular and retropharyngeal lymph nodes.

Onset of immunity: 2 weeks after the second vaccination dose.

Duration of immunity: 2 months after the second vaccination dose.

Vaccinate healthy animals only.

Effect of vaccination on further stages of the infection, rupture of developed lymph node abscesses, prevalence of subsequent carrier status, bastard strangles (metastatic abscessation), purpura haemorrhagica and myositis and recovery, is not known.

Efficacy has been demonstrated for the individual horse to reduce clinical signs of disease in the acute stage of the infection. Vaccinated horses can be infected and shed S. equi.

No information is available on the use of the vaccine in seropositive animals, including those with maternally derived antibodies.

Biosecurity procedures to limit the risk of introduction and spread of S. equi infection in premises should be part of management tools.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. An allergic reaction may occur. Treat symptomatically. Strangvac contains saponins, which have little toxicity for humans when ingested but have haemolytic effects when injected intravenously.

A transient increase in body temperature of up to 2.6°C may occur very commonly and last for one to five days following vaccination. Transient local tissue reactions are very commonly seen at the injection site, characterised by heat, pain and swelling (up to 5 cm diameter), and last for up to five days. Prevalence of injection site reactions are more pronounced after the second primary dose or re-vaccinations including increased swelling of up to 8 cm diameter. Ocular discharge is very commonly seen, which may be mucopurulent and present from both eyes for one to five days after vaccination. Loss of appetite and demeanour changes are common for up to one day. Anaphylactic-like reactions occur in very rare cases. Potential complications from vaccination and S. equi infection following challenge were not investigated.

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

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy or lactation. The use of this vaccine is not recommended during pregnancy or lactation.

Fertility:

The safety and efficacy of the vaccine has not been established in breeding males. The vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian.

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.

Intramuscular use.

Shake the vial well before use. Avoid multiple vial broaching. Avoid introduction of contamination.

It is recommended that all horses and ponies in a stable are vaccinated.

Primary vaccination course:

Administer one dose (2 ml) by intramuscular injection, followed by a second dose (2 ml) four weeks later.

Revaccination:

In horses at high risk of S. equi infections it is recommended to repeat the primary vaccination regimen after two months.

Zero days.