Strangvac - patient leaflet, side effects, dosage

PACKAGE LEAFLET:

Strangvac suspension for injection for horses and ponies

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder

Intervacc AB

Vastertorpsvagen 135

129 44 Hagersten

SWEDEN

Manufacturer responsible for batch release :

3P BIOPHARMACEUTICALS, S.L.

C/ Mocholí 2,

Polígono Industrial Mocholí,

Noáin,

Navarra,

31110,

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Strangvac suspension for injection for horses

• 3. STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS

One dose (2 ml) contains:

Active substances:

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)

Adjuvants:

Purified Quillaia Saponin QS-21 (Fraction C)

Cholesterol

Phosphatidyl choline

Colourless to yellow clear suspension.

4. INDICATION(S)

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.

Onset of immunity:

2 weeks after the second vaccination dose.

Duration of immunity:

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.

5. CONTRAINDICATIONS

None

6. ADVERSE REACTIONS

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)

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Horses.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Intramuscular use.

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

Vaccination schedule:

Primary vaccination course:

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

Re-vaccination:

Data for prolonged clinical immunity from the administration of single dose revaccinations is not available.

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

9. ADVICE ON CORRECT ADMINISTRATION

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

• 10. WITHDRAWAL PERIOD(S)

Zero days

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Do not freeze.

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

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

Do not use this veterinary medicinal product after the expiry date which is stated on the vial label after EXP. The expiry date refers to the last day of that month.

• 12. SPECIAL WARNING(S)

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 hemorrhagica 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.

Special warnings for use in animals:

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.

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 males. The vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian.

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.

Overdose (symptoms, emergency procedures, antidotes) :

Not applicable.

Incompatibilities :

Do not mix with any other veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT

OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency

• 15. OTHER INFORMATION