Bovalto Ibraxion (inactivated IBR virus) – Summary of product characteristics - QI02AA03
Updated on site: 08-Feb-2018
|Isem tal-Mediċina:||Bovalto Ibraxion|
|Sustanza:||inactivated IBR virus|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.4 Special warnings
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period(s)
- 5. IMMUNOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF REVISION OF THE TEXT
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovalto Ibraxion emulsion for injection
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
gE deleted inactivated IBR virus, at least .............................................................................
* VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
light paraffin oil ..........................................................................................................
449.6 to 488.2 mg
For the full list of excipients, see section 6.1.
Emulsion for injection
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.
4.5Special 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
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.
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.
a booster injection should be administered at 6 month intervals.
Shake well prior to use.
Allow the vaccine to reach a temperature of
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)
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
6.1List of excipients
Light paraffin oil
Polyoxyethylene oleic alcohol
Potassium dihydrogen phosphate,
Disodium phosphate dihydrate,
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
29 avenue Tony Garnier
69007 LYON FRANCE
8.MARKETING AUTHORISATION NUMBER(S)
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.