Bovalto Ibraxion (inactivated IBR virus) – Labelling - QI02AA03

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

5 doses (10 ml)

10 x 5 doses (10 x 10 ml)

10 doses (20 ml)

10 x 10 doses (10 x 20 ml)

25 doses (50 ml)

10 x 25 doses (10 x 50 ml)

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovalto Ibraxion emulsion for injection

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

 

For 1 dose of 2 ml:

 

 

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

0.75 VN.U*

 

.light paraffin oil .........................................................................................................

449.6 to 488.2 mg

 

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

 

 

 

 

 

 

 

 

 

3.

PHARMACEUTICAL FORM

 

 

 

 

 

 

 

 

 

Emulsion for injection

 

 

 

 

 

 

 

4.

PACKAGE SIZE

 

 

5 doses (10 ml)

 

 

10 x 5 doses (10 x 10 ml)

 

 

 

 

10 doses (20 ml)

 

 

 

 

 

10 x 10 doses (10 x 20 ml)

 

 

 

25 doses (50 ml)

 

 

 

 

10 x 25 doses (10 x 50 ml)

 

 

 

 

 

5.

TARGET SPECIES

 

 

Cattle

 

 

 

 

 

 

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use - SC

8.WITHDRAWAL PERIOD

Withdrawal period: zero days.

9.SPECIAL WARNING(S), IF NECESSARY

Accidental injection is dangerous.

10.EXPIRY DATE

EXP {month/year}

Once broached use by: 6 hours

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze.

Protect from light.

12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only. To be supplied only on veterinary prescription.

The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.

14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MERIAL

29 avenue Tony Garnier

69007 LYON France

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/99/017/001 5 doses (10 ml) EU/2/99/017/004 10 x 5 doses (10 x 10 ml) EU/2/99/017/002 10 doses (20 ml) EU/2/99/017/005 10 x 10 doses (10 x 20 ml) EU/2/99/017/003 25 doses (50 ml) EU/2/99/017/006 10 x 25 doses (10 x 50 ml)

17.MANUFACTURER’S BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

5 doses (10 ml)

10 doses (20 ml)

25 doses (50 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovalto Ibraxion emulsion for injection

Cattle

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

For 1 dose of 2 ml: gE deleted inactivated IBR virus, at least ................................................

0.75 VN.U

3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

5 doses (10 ml)

10 doses (20 ml)

25 doses (50 ml)

4. ROUTE(S) OF ADMINISTRATION

SC

5. WITHDRAWAL PERIOD

Withdrawal period: Zero days

6.BATCH NUMBER

Lot

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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