Xaluprine (Mercaptopurine Nova Laboratories) (6-mercaptopurine monohydrate) – Labelling - L01BB02

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Xaluprine 20 mg/ml oral suspension mercaptopurine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of suspension contains 20 mg mercaptopurine (as monohydrate).

3.LIST OF EXCIPIENTS

Also contains: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), potassium sorbate (E202), sodium hydroxide, aspartame (E951) and sucrose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Oral suspension.

100 ml glass bottle Bottle adaptor

1 ml and 5 ml dosing syringes.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Take as directed by your doctor using the dosing syringes provided.

Shake vigorously before use for at least 30 seconds.

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic.

8.EXPIRY DATE

EXP:

Discard 56 days after first opening.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Keep the bottle tightly closed.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused product waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Nova Laboratories Limited

Martin House

Gloucester Crescent

Wigston, Leicester

LE18 4YL

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/727/001

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to restricted medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Xaluprine 20 mg/ml

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Xaluprine 20 mg/ml oral suspension mercaptopurine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of suspension contains 20 mg mercaptopurine (as monohydrate).

3. LIST OF EXCIPIENTS

Also contains: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215) potassium sorbate (E202), sodium hydroxide, aspartame (E951) and sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Oral suspension.

100 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Take as directed by your doctor using the dosing syringes provided.

Shake vigorously before use for at least 30 seconds.

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

8. EXPIRY DATE

EXP:

Discard 56 days after first opening.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Keep the bottle tightly closed.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused product waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Nova Laboratories Limited

Martin House

Gloucester Crescent

Wigston, Leicester

LE18 4YL

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/727/001

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to restricted medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE