Bovela (modified live bovine viral diarrhoea...) – Labelling - QI02AD02

Updated on site: 08-Feb-2018

Medication name: Bovela
ATC: QI02AD02
Substance: modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93
Manufacturer: Boehringer Ingelheim Vetmedica GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box: 5 doses, 10 doses, 25 doses, 50 doses lyophilisate and 10 ml, 20 ml, 50 ml, 100 ml solvent

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovela lyophilisate and solvent for suspension for injection for cattle

2.STATEMENT OF ACTIVE SUBSTANCES

Each dose (2 ml) contains:

Bovine viral diarrhoea virus type 1,

Bovine viral diarrhoea virus type 2.

3.PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection

4.PACKAGE SIZES

5 doses (10 ml)

10 doses (20 ml)

25 doses (50 ml)

50 doses (100 ml)

4 x 5 doses (10 ml)

4 x 10 doses (20 ml)

4 x 25 doses (50 ml)

4 x 50 doses (100 ml)

6 x 5 doses (10 ml)

6 x 10 doses (20 ml)

6 x 25 doses (50 ml)

6 x 50 doses (100 ml)

10 x 5 doses (10 ml)

10 x 10 doses (20 ml)

10 x 25 doses (50 ml)

10 x 50 doses (100 ml)

5.TARGET SPECIES

Cattle

6.INDICATION

7.METHOD AND ROUTE OF ADMINISTRATION

Intramuscular use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal period: Zero days.

9.SPECIAL WARNINGS, IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

Once reconstituted use within 8 hours.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze.

Keep the vials in the outer carton.

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.

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

16.MARKETING AUTHORISATION NUMBERS

EU/2/14/176/001 5 doses and 10 ml EU/2/14/176/002 5 doses and 10 ml (4 x) EU/2/14/176/003 5 doses and 10 ml (6 x) EU/2/14/176/004 5 doses and 10 ml (10 x) EU/2/14/176/005 10 doses and 20 ml EU/2/14/176/006 10 doses and 20 ml (4 x) EU/2/14/176/007 10 doses and 20 ml (6 x) EU/2/14/176/008 10 doses and 20 ml (10 x) EU/2/14/176/009 25 doses and 50 ml EU/2/14/176/010 25 doses and 50 ml (4 x) EU/2/14/176/011 25 doses and 50 ml (6 x) EU/2/14/176/012 25 doses and 50 ml (10 x) EU/2/14/176/013 50 doses and 100 ml EU/2/14/176/014 50 doses and 100 ml (4 x) EU/2/14/176/015 50 doses and 100 ml (6 x) EU/2/14/176/016 50 doses and 100 ml (10 x)

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Lyophilisate vials: 50 doses

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovela lyophilisate for suspension for injection for cattle

2. STATEMENT OF ACTIVE SUBSTANCES

Each dose (2 ml) contains:

Bovine viral diarrhoea virus type 1,

Bovine viral diarrhoea virus type 2.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension for injection

4. PACKAGE SIZE

50 doses (100 ml)

5. TARGET SPECIES

Cattle

6. INDICATION

7. METHOD AND ROUTE OF ADMINISTRATION

IM

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Withdrawal period: Zero days.

9. SPECIAL WARNINGS, IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

Once reconstituted use within: 8 hours.

11. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze.

Keep the vial in the outer carton.

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.

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

Boehringer Ingelheim Vetmedica GmbH

GERMANY

16. MARKETING AUTHORISATION NUMBERS

EU/2/14/176/013 50 doses

EU/2/14/176/014 4 x 50 doses

EU/2/14/176/015 6 x 50 doses

EU/2/14/176/016 10 x 50 doses

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Lyophilisate vials: 5 doses, 10 doses and 25 doses

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovela lyophilisate for suspension for injection for cattle

2.QUANTITY OF THE ACTIVE SUBSTANCES

Each dose (2 ml) contains:

Live BVDV-1 and BVDV-2.

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 OF ADMINISTRATION

IM

5.WITHDRAWAL PERIOD

Withdrawal period: Zero days.

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

Once reconstituted use within: 8 hours.

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Solvent bottles: 10 ml, 20 ml, 50 ml, 100 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Solvent for Bovela

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

10 ml

20 ml

50 ml

100 ml

3.ROUTE OF ADMINISTRATION

Read the package leaflet before use.

4.STORAGE CONDITIONS

Store and transport refrigerated.

Keep the bottle in the outer carton.

5.BATCH NUMBER

Lot {number}

6.EXPIRY DATE

EXP {month/year}

7.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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