Purevax RCP FeLV (Attenuated feline rhinotracheitis herpesvirus...) – Labelling - QI06AX

Updated on site: 09-Feb-2018

Medication name: Purevax RCP FeLV
ATC: QI06AX
Substance: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97)
Manufacturer: Merial

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Pack of 10 bottles of lyophilisate and 10 bottles of solvent

Pack of 50 bottles of lyophilisate and 50 bottles of solvent

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Purevax RCP FeLV lyophilisate and solvent for suspension for injection

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

 

Per dose of 1 ml:

≥ 104.9 CCID50

 

FHV (F2 strain) .................................................................................................................

 

FCV (431 and G1 strains) ...............................................................................................

≥ 2.0 ELISA U.

 

FPV (PLI IV).....................................................................................................................

≥ 103.5 CCID50

 

FeLV recombinant canarypox virus (vCP97)...................................................................

≥ 107.2 CCID50.

 

 

 

 

 

 

3.

PHARMACEUTICAL FORM

 

 

 

 

 

 

 

Lyophilisate and solvent for suspension for injection.

 

 

 

 

 

4.

PACKAGE SIZE

 

 

Lyophilisate (10x1 dose) + solvent (10x1 ml)

 

 

Lyophilisate (50x1 dose) + solvent (50x1 ml)

 

 

 

 

 

5.

TARGET SPECIES

 

 

Cats

 

 

 

 

6.INDICATION(S)

Read the package leaflet before use.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

8.WITHDRAWAL PERIOD

Not applicable.

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP (mm/yyyy)

Once reconstituted use immediately.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Protect from light.

Do not freeze.

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

MERIAL

29, avenue Tony Garnier 69007 LYON FRANCE

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/04/048/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/048/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)

17.MANUFACTURER’S BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate bottle

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Purevax RCP FeLV

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

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

7.EXPIRY DATE

EXP (mm/yyyy)

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottle

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Purevax RCP FeLV solvent

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

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

7.EXPIRY DATE

EXP (mm/yyyy)

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

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