Bovalto Ibraxion (inactivated IBR virus) – Summary of product characteristics - QI02AA03

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovalto Ibraxion emulsion for injection

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance
Each dose of 2 ml contains:
gE deleted inactivated IBR virus, at least .............................................................................		0.75 VN.U*
* VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Adjuvant
light paraffin oil ..........................................................................................................		449.6 to 488.2 mg
For the full list of excipients, see section 6.1.
3.	PHARMACEUTICAL FORM

Emulsion for injection

4.CLINICAL PARTICULARS

4.1Target species

Cattle

4.2Indications for use, specifying the target species

Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.

Onset of immunity: 14 days

Duration of immunity: 6 months.

4.3 Contraindications

None

4.4Special warnings

None.

4.5Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

To the user:

This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:

This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

4.6Adverse reactions (frequency and seriousness)

The injection of the vaccine may cause a transient tissue reaction at the site of injection, which may persist for three weeks and rarely up to five weeks.

The vaccination may cause a slight rise in body temperature (less than 1°C) for a transient period (less than 48 hours after injection) without any consequence to the health or performance of the animal.

A hypersensitivity reaction may occur. These are rare and an appropriate symptomatic treatment should be administered.

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

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

4.7Use during pregnancy, lactation or lay

Bovalto Ibraxion can be used during pregnancy and lactation.

4.8Interaction 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.

4.9Amounts to be administered and administration route

Administer one dose (2 ml) by subcutaneous injection in the neck (at the front of the shoulder) according to the following regimen:

The presence of maternally derived antibodies against infectious bovine rhinotracheitis virus may interfere with the vaccination and requires an appropriate vaccination regimen.

Basic vaccination:	two injections 21 days apart. For use in animals from the age of 2 weeks in
	the absence of maternally derived antibodies against IBR virus or from the
	age of 3 months in the presence of maternally derived antibodies.
Revaccination:	a booster injection should be administered at 6 month intervals.

Shake well prior to use.

Allow the vaccine to reach a temperature of 15°C-25°C.

Use sterile syringes and needles

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

No undesirable effects other than those mentioned in section 4.6 have been observed after the administration of an overdose.

4.11 Withdrawal period(s)

Zero days

5.IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals, bovine rhinotracheitis virus (IBR) ATCvet code: QI02AA03

Bovalto Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/w emulsion) vaccine which acts by the active immunisation of cattle characterised by the production of Infectious Bovine Rhinotracheitis (IBR) vironeutralising antibodies.

The gE gene deletion allows differentiation between animals vaccinated with gE-negative vaccines (anti gE antibody negative, IBR vironeutralising antibody positive) and naturally infected animals (positive to both IBR vironeutralising antibody and anti gE antibody). Bovalto Ibraxion can therefore be used as a marker vaccine in association with an appropriate diagnostic test.

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Light paraffin oil

Benzyl alcohol

Triethanolamine

Polyoxyethylene oleate

Polyoxyethylene oleic alcohol

Potassium chloride,

Sodium chloride,

Potassium dihydrogen phosphate,

Disodium phosphate dihydrate,

Magnesium chloride,

Calcium chloride

6.2Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months Shelf life after first opening the immediate packaging: 6 hours

6.4.Special precautions for storage

Store and transport refrigerated (2°C- 8°C),

Do not freeze.

Protect from light.

6.5Nature and composition of immediate packaging

Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses (1 x 10 ml or 10 x 10 ml)

Cardboard box with 1 or 10 bottles of 10 doses (1 x 20 ml or 10 x 20 ml) Cardboard box with 1 or 10 bottles of 25 doses (1 x 50 ml or 10 x 50 ml)

Not all pack sizes may be marketed.

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 products should be disposed of in accordance with local requirements.

7.MARKETING AUTHORISATION HOLDER

MERIAL

29 avenue Tony Garnier

69007 LYON FRANCE

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/99/017/001-006

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09/03/2000

Date of last renewal: 23/03/2010

10.DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

The manufacture, import, possession, sale, supply and/or use of Bovalto Ibraxion may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. Any person intending to manufacture, import, possess, sell, supply and/or use Bovalto Ibraxion must consult the relevant Member State’s competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.