Equilis Prequenza Te (equine influenza-virus strains: A/equine-2/South...) – Summary of product characteristics - QI05AL01

Updated on site: 21-Sep-2017

Naziv lijeka: Equilis Prequenza Te
ATC: QI05AL01
Tvar: equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93, tetanus toxoid
Proizvođač: Intervet International BV

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Equilis Prequenza Te suspension for injection for horses

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Per dose of 1 ml:

 

 

Active substances:

 

 

Equine influenza virus strains:

 

AU1

A/equine-2/ South Africa/4/03

A/equine-2/ Newmarket/2/93

50 AU

Tetanus toxoid

Lf2

1Antigenic units

2Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur. potency test

Adjuvants:

 

Purified Saponin

375 micrograms

Cholesterol

125 micrograms

Phosphatidylcholine

62.5 micrograms

For a full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Clear opalescent suspension for injection

4.CLINICAL PARTICULARS

4.1Target species

Horses

4.2Indications for use, specifying the target species

Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.

Influenza

 

Onset of immunity:

2 weeks after the primary vaccination course

Duration of immunity:

5 months after the primary vaccination course

Tetanus

12 months after the first revaccination

 

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

4.3Contraindications

None

4.4Special warnings

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.

4.5Special precautions for use

Only healthy animals should be vaccinated.

Special precautions for use in animals

Not applicable

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.

4.6Adverse reactions (frequency and seriousness)

A diffuse hard or soft swelling (max. diameter 5 cm) may 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.

4.7Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8Interaction 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 (see section 4.9).

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.

4.9Amounts to be administered and administration route

Intramuscular use

Vaccination schedule:

Primary vaccination course

Administer one dose (1 ml), by strict intramuscular injection, according to the following schedule:

Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later

Revaccination

Influenza

It is recommended that a single booster dose should only be administered to horses that have already received a primary vaccination course using vaccines that contain the same types of equine influenza virus included in this vaccine. A primary vaccination course may be considered necessary in horses that have not been suitably primed.

The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course. This revaccination results in immunity to equine influenza lasting at least 12 months.

The second revaccination is given 12 months after the first revaccination.

The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).

Tetanus

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).

V1

V2

V3

V4

V5

V6

 

 

 

 

 

42 months

 

 

 

 

Prequenza

Prequenza Prequenza

 

Prequenza Te

 

Prequenza

 

Prequenza Te

Te

Te

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In case of increased infection risk or insufficient colostrum intake, an additional initial injectioncan 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 from Intervet 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 from Intervet 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 Prequenza Te should be repeated at least four weeks later. Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza 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

4.6 have been observed except for some depression at the day of vaccination

4.11 Withdrawal period(s)

Zero days

5.IMMUNOLOGICAL PROPERTIES

To stimulate active immunity against Equine influenza and tetanus

ATC-vet code: QI05AL01

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Phosphate buffer, traces of thiomersal, traces of formaldehyde

6.2Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3Shelf life

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

6.4Special precautions for storage

Store at 2-8°C, protected from light. Do not freeze.

6.5Nature and composition of immediate packaging

Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap. 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 of 1 ml.

Cardboard box(es) with 1, 5 or 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

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

7.MARKETING AUTHORISATION HOLDER

Intervet International B.V.

Wim de Körverstraat 35

NL-5831 AN Boxmeer

The Netherlands

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/05/057/001-004

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08 July 2005 / 27 July 2010

10.DATE OF REVISION OF THE TEXT

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable

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