Imrestor (Pegbovigrastim) – Labelling - QL03AA90

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cartons of 10, 50 or 100 syringes

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Imrestor 15 mg solution for injection for cattle pegbovigrastim

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each 2.7 ml pre-filled syringe contains 15 mg pegbovigrastim.

3.PHARMACEUTICAL FORM

Solution for injection

4.PACKAGE SIZE

10 pre-filled syringes

50 pre-filled syringes

100 pre-filled syringes

5.TARGET SPECIES

Cattle (dairy cows and heifers)

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal period:

Meat and offal: zero days

Milk: zero days

9.SPECIAL WARNING(S), IF NECESSARY

10.EXPIRY DATE

EXP {month/year}

11.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2 C – 8 C).

Do not freeze.

Sensitive to light. Store in original packaging.

The product may be stored at 25 °C for 24 hours maximum.

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

Eli Lilly and Company Limited

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/15/193/001-003

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 2.7 ml pre-filled syringe

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Imrestor 15 mg injection pegbovigrastim

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

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

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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