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Versican Plus Pi (canine parainfluenza type-2 virus, strain...) – Labelling - QI07AD08

Updated on site: 09-Feb-2018

Medication name: Versican Plus Pi
ATC: QI07AD08
Substance: canine parainfluenza type-2 virus, strain CPiV-2 Bio 15 (live attenuated)
Manufacturer: Zoetis Belgium SA

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

BOX

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Versican Plus Pi lyophilisate and solvent for suspension for injection for dogs

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

 

Per dose (1 ml):

 

 

 

Lyophilisate (live attenuated):

Minimum

Maximum

 

Canine parainfluenza Type 2 virus

103.1 TCID50

105.1 TCID50

 

Solvent:

 

 

 

Water for injections

(Aqua ad iniectabilia)

 

 

 

 

 

 

 

 

 

 

 

 

 

3.

PHARMACEUTICAL FORM

 

 

 

 

 

 

 

 

 

Lyophilisate and solvent for suspension for injection

 

 

 

 

 

 

 

 

 

4.

PACKAGE SIZE

 

 

 

25 x 1 dose

 

 

 

50 x 1 dose

 

 

 

5.TARGET SPECIES

Dogs

6.INDICATION(S)

Read the package leaflet before use.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

Once reconstituted, use immediately.

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

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

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/14/168/001

EU/2/14/168/002

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (1 dose lyophilisate)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Versican Plus Pi lyophilisate for dogs

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Pi

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

1 dose

4. ROUTE(S) OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (1 ml solvent)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Versican Plus Pi solvent for dogs

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

Aqua ad iniectabilia

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

1 ml

4. ROUTE(S) OF ADMINISTRATION

SC

5. WITHDRAWAL PERIOD

6. BATCH NUMBER

Lot {number}

7. EXPIRY DATE

EXP {month/year}

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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