Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 7. OTHER SPECIAL WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 9. SPECIAL STORAGE CONDITIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL CLASSIFICATION FOR SUPPLY
- 15. INSTRUCTIONS ON USE
- 16. INFORMATION IN BRAILLE
- 17. UNIQUE IDENTIFIER – 2D BARCODE
- 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
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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.
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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
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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
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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
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