Equilis Te - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Equilis Te suspension for injection for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 1 ml contains:

Active substance:

Tetanus toxoid            40 Lf 1

• 1 Flocculation equivalents; corresponds with > 30 lU/ml guinea pig serum in the Ph. Eur. potency test

Adjuvants:

Purified Saponin           375 tig

Cholesterol                 125 tig

Phosphatidylcholine        62.5 tig

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Suspension for injection.

Clear opalescent suspension.

4. CLINICAL PARTICULARS4.1 Target species

Horses

• 4.2 Indications for use, specifying the target species

Active immunisation of horses from 6 months of age against tetanus to prevent mortality.

Onset of immunity:      2 weeks after the primary vaccination course

Duration of immunity: 17 months after the primary vaccination course

24 months after the first revaccination

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.

• 4.5 Special precautions for use

Special precautions for use in animals

Only healthy animals should be vaccinated.

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.

• 4.6 Adverse reactions (frequency and seriousness)

A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days. In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.

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

• – very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

• – common (more than 1 but less than 10 animals in 100 animals)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals)

• – rare (more than 1 but less than 10 animals in 10,000 animals)

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

• 4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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

Allow the vaccine to reach room temperature before use.

Vaccination schedule :

Primary vaccination course

• Administer one dose (1ml), by intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later

Revaccination

The first revaccination is given not later than 17 months after the primary vaccination course. Thereafter a maximum interval of two years is recommended (see scheme).

In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)

Concurrent active and passive immunisation (emergency vaccination)

The vaccine can be used together with Tetanus-Serum for treatment of injured horses that have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum at a separate injection site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4 weeks later. A third vaccination with Equilis Te should be repeated at least four weeks later. Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.

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

Following the administration of a double dose of vaccine, no side effects other than those described under section 4.6 have been observed except for some depression at the day of vaccination.

• 4.11 Withdrawal period

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

To stimulate active immunity against tetanus.

Pharmacotherapeutic group: Inactivated bacterial vaccine.

ATC vet code: QI05AB03

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Lactose

Phosphate buffer

Chloride buffer

Traces of formaldehyde

Purified Saponin

Cholesterol

Phosphatidylcholine

6.2 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

6.4 Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Protect from light.

Do not freeze.

• 6.5 Nature and composition of immediate packaging

• 1 ml suspension in type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.

• 1 ml suspension in type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.

Package size:

Cardboard box with 10 glass vials.

Cardboard box with 10 pre-filled syringes with needles.

Not all pack sizes may be marketed.

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

7. MARKETING AUTHORISATION HOLDER

Intervet International B.V.

Wim de Korverstraat 35

5831 AN Boxmeer

The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/05/055/001–002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 08/07/2005

Date of last renewal: 10/06/2015