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Oncept IL-2 (vCP1338 virus) – Labelling - QL03AX

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box of 6 vials of lyophilisate and 6 vials of solvent

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Oncept IL-2 lyophilisate and solvent for suspension for injection for cats

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Feline interleukin-2 recombinant canarypox virus (vCP1338) ........................................

≥ 106.0 EAID50

3.PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection

4.PACKAGE SIZE

Lyophilisate: 6 x 1 dose

Solvent: 6 x 1 ml

5.TARGET SPECIES

Cats

6.INDICATION

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}

Use immediately after reconstitution.

11.SPECIAL STORAGE CONDITIONS

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

Store in the original package in order to protect from light.

Do not freeze.

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 NUMBER(S)

EU/2/13/150/001

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Oncept IL-2 lyophilisate

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

Read the package leaflet before use.

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 Solvent vial

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Solvent for Oncept IL-2

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

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

1 ml

4. ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

5. WITHDRAWAL PERIOD

6. BATCH NUMBER

Lot {number}

7. EXPIRY DATE

EXP {month/year}

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

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