Quadrisol (vedaprofen) – Labelling - QM01AE90

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

100 mg/ml oral gel for horses

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Quadrisol 100 mg/ml oral gel for horses

2.STATEMENT OF ACTIVE SUBSTANCES

Vedaprofen:

100 mg/ml

3.PHARMACEUTICAL FORM

Oral gel.

4.PACKAGE SIZE

Adjustable dose syringe, containing 30 ml gel

3 adjustable dose syringes, each containing 30 ml gel

5.TARGET SPECIES

Horse.

6.INDICATION(S)

Reduction of inflammation and relief of pain.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

Withdrawal period(s): Meat and offal: 12 days.

Not authorised for use in lactating animals producing milk for human consumption.

9.SPECIAL WARNINGS, IF NECESSARY

If side effects occur, treatment should be discontinued.

Do not use in lactating mares.

For full contra-indications, see package leaflet.

10.EXPIRY DATE

EXP: {Month/year}

11.SPECIAL STORAGE CONDITIONS

No special precautions for storage.

Shelf-life after first opening the immediate packaging: 2 months.

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

VETCOOL B.V.

Otto Hahnweg 24

3542 AX Utrecht

NETHERLANDS

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/97/005/001 (1 x 30 ml)

EU/2/97/005/005 (3 x 30 ml)

17.MANUFACTURER’S BATCH NUMBER

Lot: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {label on the syringe}

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Quadrisol 100 mg/ml oral gel for horses

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Vedaprofen:

100 mg/ml

Propylene glycol:

130 mg/ml

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

30 ml

4.ROUTE(S) OF ADMINISTRATION

For oral use.

5.WITHDRAWAL PERIOD(S)

Withdrawal period(s):

Meat and offal: 12 days

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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