Strangvac - summary of medicine characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Strangvac suspension for injection for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (2 ml) contains:

Recombinant protein CCE from Streptococcus equi

Recombinant protein Eq85 from Streptococcus equi

Recombinant protein IdeE from Streptococcus equi

• *as determined by means of in vitro potency tests (ELISA) *

Purified Quillaia Saponin QS-21 (Fraction C)

Cholesterol

Phosphatidyl choline

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

Colourless to pale yellow suspension.

4. CLINICAL PARTICULARS4.1 Target species

Horses

4.2 Indications for use, specifying the target species

For active immunisation of horses from 8 months of age for:

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

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

• - 2 weeks after the second vaccination dose.

2 months after the second vaccination dose

The vaccine is intended for use in horses for which a high risk of Streptococcus equi infection has been clearly identified from areas where this pathogen is known to be present.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

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, regardless of vaccination with this product.

4.5 Special precautions for use

The vaccine is tested safe for use in horses from the age of 5 months.

Special 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. An allergic reaction may occur. Treat symptomatically.

4.6 Adverse reactions (frequency and seriousness)

A transient increase in body temperature of up to 2.6°C for one to five days is very common following vaccination.

Transient local tissue reactions at the injection site, characterised by heat, pain and swelling (approximately 5 cm diameter) are very commonly seen and last for up to five days. Frequency of injection site reactions are more pronounced after the second primary dose and further doses and increased swelling of up to 8 cm diameter can occur.

Loss of appetite and demeanour changes for one day are common.

Ocular discharge which may be mucopurulent and present from both eyes is very commonly seen for one to five days after vaccination.

Anaphylactic-like reactions occur in very rare cases.

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

• - very common (more than 1 in 10 animals treated displaying adverse reactions)

• - 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, including isolated reports)

• 4.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

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

Fertility:

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

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 made on a case by case basis.

4.9 Amounts to be administered and administration route

Intramuscular use.

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

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

Data for prolonged clinical immunity from the administration of single dose revaccinations are not available. Therefore, in horses at high risk of S. equi infections it is recommended to repeat the primary vaccination regimen after two months.

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

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunological for Equidae , inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia), Streptococcus.

ATCvet code: QI05AB01

The vaccine contains recombinant protein antigens derived from Streptococcus equi , which are not living and cannot spread to other animals. Strangvac stimulates active immunity against Streptococcus equi, the causative agent of strangles in horses. After vaccination, in addition to antibodies in the blood, local antibodies (IgG) can also be detected in secretions from the nasal passages. The immunogenicity of the Streptococcus equi antigens is enhanced by ISCOM (Immune Stimulating COMplex).

Efficacy of vaccination was demonstrated in studies using an experimental challenge model of the acute stage of the infection with the heterologous strain, Streptococcus equi 4047 (isolated in New Forest, UK in 1990).

After challenge (two weeks and two months after the second dose of vaccine), vaccinated horses demonstrated reduced acute clinical signs compared to unvaccinated controls.

Of the vaccinated animals,

• - 43% (12 out of 28 ponies) remained pyrexia free (pyrexia defined as 390C or above for two out of

three days). The number of days with pyrexia was significantly lower in the vaccinated compared to non-vaccinated animals.

• - 36% (10 out of 28) did not show signs of coughing.

• - 43% (12 out of 28 ponies) did not show signs of difficulty in swallowing.

• - 43 % (12 out of 28) did not show signs of marked depression (inappetence, marked change in

demeanour) after challenge.

Based on measured antibody titers immunological memory response was found in horses following repeated vaccination 6 months after primary vaccination. The role of the measured antibodies in the immune response relevant for the protection against strangles is not known.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Purified Quillaia Saponin QS-21 (Fraction C)

Cholesterol

Phosphatidyl choline

Sodium chloride

Trometamol

Polysorbate 80

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: use immediately.

6.4 Special precautions for storage

Store and transport refrigerated (2°C – 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

6.5 Nature and composition of immediate packaging

Type I glass vial closed with a bromobutyl rubber stopper and sealed with a white aluminium crimp cap.

Cardboard box with 8 vials of 1 dose (2 ml)

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

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

7. MARKETING AUTHORISATION HOLDER

Intervacc AB Vastertorpsvagen 135 129 44 Hagersten SWEDEN

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/21/274/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: <{DD/MM/YYYY}>