Acticam (meloxicam) – Labelling - QM01AC06

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Acticam 5 mg/ml solution for injection for dogs and cats. Meloxicam.

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Meloxicam 5 mg/ml.

Ethanol anhydrous 150 mg/ml.

3.PHARMACEUTICAL FORM

Solution for injection.

4.PACKAGE SIZE

10 ml.

5.TARGET SPECIES

6.INDICATIONS

7.METHOD AND ROUTES OF ADMINISTRATION

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

9.SPECIAL WARNINGS, IF NECESSARY

Do not use in pregnant or lactating animals.

10.EXPIRY DATE

EXP {month/year}

Shelf-life after first opening the container: 28 days.

Once broached use by ...

11.SPECIAL STORAGE CONDITIONS

This veterinary product does not require any special storage conditions.

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

Dispose of waste material in accordance with local requirements.

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

Ecuphar NV

Legeweg 157-i

B-8020 Oostkamp

Belgium

16.MARKETING AUTHORISATION NUMBER

EU/2/08/088/004

17.MANUFACTURER’S BATCH NUMBER

Lot: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Acticam 5 mg/ml solution for injection for dogs and cats.

Meloxicam.

2.QUANTITY OF THE ACTIVE SUBSTANCE

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

10 ml.

4.ROUTES OF ADMINISTRATION

Dogs: i.v. or s.c.

Cats: s.c.

5.WITHDRAWAL PERIOD

6.BATCH NUMBER

Lot: {number}

7.EXPIRY DATE

EXP {month/year}

Shelf life after first opening the container: 28 days

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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