Bovalto Ibraxion (inactivated IBR virus) – Package leaflet - QI02AA03

Updated on site: 21-Sep-2017

Medication name: Bovalto Ibraxion
ATC: QI02AA03
Substance: inactivated IBR virus
Manufacturer: Merial

PACKAGE LEAFLET FOR

Bovalto Ibraxion emulsion for injection

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

Marketing authorisation holder MERIAL

29 avenue Tony Garnier -69007 Lyon France

Manufacturer responsible for batch release

MERIAL

Laboratoire Porte des Alpes

Rue de l'Aviation-69800 Saint Priest

France

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovalto Ibraxion emulsion for injection

3.STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Each dose (2 ml) contains:

 

gE deleted inactivated IBR virus, at least .............................................................................

0.75 VN.U*

adjuvant: light paraffin oil ...........................................................................................

449.6 to 488.2 mg

* VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.

 

4.INDICATION(S)

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.

5.CONTRAINDICATIONS

None

6.ADVERSE REACTIONS

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 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).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Cattle

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

Shake well prior to use.Allow the vaccine to reach a temperature of 15 -25ºC. Use sterile syringes and needles.

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.

9.ADVICE ON CORRECT ADMINISTRATION

See above.

10.WITHDRAWAL PERIOD

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.

Protect from light.

Shelf life after first opening the container: 6 hours

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

12.SPECIAL WARNING(S)

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 insert 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.

Pregnancy and lactation:

Bovalto Ibraxion can be used during pregnancy and lactation.

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:

No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of an overdose.

Incompatibilities:

Do not mix with any other veterinary medicinal product.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

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

15.OTHER INFORMATION

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.

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.

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

Cardboard box with 1 or 10 bottles of 10 doses Cardboard box with 1 or 10 bottles of 25 doses

Not all pack sizes may be marketed.

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