Parvoduk (live attenuated Muscovy duck parvovirus) – Labelling - QI01BD03

Updated on site: 09-Feb-2018

Medication name: Parvoduk
ATC: QI01BD03
Substance: live attenuated Muscovy duck parvovirus
Manufacturer: Merial

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Box of suspension

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Parvoduk suspension for injection for Muscovy ducks

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

One reconstituted dose of 0.2 ml contains:

2.6–4.8 log10 CCID50.

Live attenuated Muscovy duck parvovirus strain GM 199 ....................................

3.PHARMACEUTICAL FORM

Suspension for injection.

4.PACKAGE SIZE

10 x 500 doses

2,500 doses

5.TARGET SPECIES

Muscovy ducks.

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal period: zero days.

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP

Once reconstituted, use within 4 hours.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated (2° C – 8° C).

Do not freeze.

Protect from light.

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

Read the package leaflet before use.

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

MERIAL

29, avenue Tony Garnier 69007 Lyon

FRANCE

16.MARKETING AUTHORISATION NUMBERS

EU/2/14/162/001

EU/2/14/162/002

17.MANUFACTURER’S BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Box of diluent

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Parvoduk diluent for injection for Muscovy ducks

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Saline buffer

3. PHARMACEUTICAL FORM

4. PACKAGE SIZE

10 x 500 doses

2,500 doses

5. TARGET SPECIES

Muscovy ducks.

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Withdrawal period: zero days.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP

11. SPECIAL STORAGE CONDITIONS

Store below 25° C.

Do not freeze.

Protect from light.

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

Read the package leaflet before use.

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

MERIAL

29, avenue Tony Garnier 69007 Lyon

FRANCE

16. MARKETING AUTHORISATION NUMBERS

EU/2/14/162/001

EU/2/14/162/002

17. MANUFACTURER’S BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials of suspension

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Parvoduk suspension

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Live attenuated Muscovy duck parvovirus.

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

500 doses

2,500 doses

4.ROUTE(S) OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD

Withdrawal period: zero days.

6.BATCH NUMBER

Lot

7.EXPIRY DATE

EXP

Once reconstituted, use within 4 hours.

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Bags of diluent

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Diluent for Parvoduk suspension

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Saline buffer

3. PHARMACEUTICAL FORM

4. PACKAGE SIZE

500 doses.

2,500 doses.

5. TARGET SPECIES

Muscovy ducks.

6. INDICATION

Read the package leaflet before use.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Withdrawal period: zero days.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP

11. SPECIAL STORAGE CONDITIONS

Store below 25° C.

Do not freeze.

Protect from light.

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

Read the package leaflet before use.

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 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/2/14/162/001

EU/2/14/162/002

17. MANUFACTURER’S BATCH NUMBER

Lot

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