Summary of medicine characteristics - Bovalto Ibraxion
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.
3. PHARMACEUTICAL FORM
Emulsion for injection
4. CLINICAL PARTICULARS
4.1 Target species
Cattle
4.2 Indications for use, specifying the target species
Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
4.3 Contraindications
None
Onset of immunity: 14 days
Duration of immunity: 6 mon
4.4 Special wa
None.
4.5
precautions for use
cautions for use in animals inate 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 ve small amount is injected and take the package leaflet with you.If pain persists for more 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.
4.6 Adverse 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).
4.7 Use during pregnancy, lactation or lay
Bovalto Ibraxion can be used during pregnancy and lactation.
4.8 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.
4.9 Amounts 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:
Revaccination:
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 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, ATCvet code: QI02AA03
rus (IBR)
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 bet
o
n 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
6.1 List 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
6.2 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: 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.
6.5 Nature and composition of immediate packaging
Type I glass bottles with a Nitrile elastomer closure and sealed with an alumini Cardboard box with 1 or 10 bottles of 5 doses (1 × 10 ml or 10 × 10 ml) Cardboard box with 1 or 10 bottles of 10 doses (1 × 20 ml or 10 × 20 ml) Cardboard box with 1 or 10 bottles of 25 doses (1 × 50 ml or 10 × 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