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Temodal (temozolomide) – Labelling - L01AX03

Updated on site: 10-Oct-2017

Medication nameTemodal
ATC CodeL01AX03
Substancetemozolomide
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg

1.NAME OF THE MEDICINAL PRODUCT

Temodal 5 mg hard capsules temozolomide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 5 mg temozolomide.

3.LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules

20 hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

Store in the original bottle in order to protect from moisture.

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 medicinal product or waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/001 (5 hard capsules)

EU/1/98/096/002 (20 hard capsules)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Temodal 5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg

1. NAME OF THE MEDICINAL PRODUCT

Temodal 20 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 20 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules

20 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

Store in the original bottle in order to protect from moisture.

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 medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/003 (5 hard capsules)

EU/1/98/096/004 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 20 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg

1. NAME OF THE MEDICINAL PRODUCT

Temodal 100 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 100 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules

20 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

Store in the original bottle in order to protect from moisture.

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 medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/005 (5 hard capsules)

EU/1/98/096/006 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 100 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg

1. NAME OF THE MEDICINAL PRODUCT

Temodal 140 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 140 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules

20 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the enclosed 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, preferably in a locked cupboard. Accidental -ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

Store in the original bottle in order to protect from moisture.

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 medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/009 (5 hard capsules)

EU/1/98/096/010 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 140 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg

1. NAME OF THE MEDICINAL PRODUCT

Temodal 180 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 180 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules

20 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the enclosed 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, preferably in a locked cupboard. Accidental -ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

Store in the original bottle in order to protect from moisture.

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 medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/011 (5 hard capsules)

EU/1/98/096/012 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 180 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg

1. NAME OF THE MEDICINAL PRODUCT

Temodal 250 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 250 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules

20 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

Store in the original bottle in order to protect from moisture.

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 medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/007 (5 hard capsules)

EU/1/98/096/008 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 250 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 5 mg hard capsules temozolomide

Oral use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 hard capsules

20 hard capsules

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 20 mg hard capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 hard capsules

20 hard capsules

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 100 mg hard capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 hard capsules

20 hard capsules

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 140 mg hard capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 hard capsules

20 hard capsules

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 180 mg hard capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 hard capsules

20 hard capsules

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 250 mg hard capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 hard capsules

20 hard capsules

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg INDIVIDUALLY SEALED IN SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temodal 5 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 5 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules in sachets

20 hard capsules in sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/024 (5 hard capsules)

EU/1/98/096/025 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg INDIVIDUALLY SEALED IN SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temodal 20 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 20 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules in sachets

20 hard capsules in sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/013 (5 hard capsules)

EU/1/98/096/014 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 20 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg INDIVIDUALLY SEALED IN SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temodal 100 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 100 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules in sachets

20 hard capsules in sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/015 (5 hard capsules)

EU/1/98/096/016 (20 hard capsules

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 100 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg INDIVIDUALLY SEALED IN SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temodal 140 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 140 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules in sachets

20 hard capsules in sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the enclosed 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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/017 (5 hard capsules)

EU/1/98/096/018 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 140 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg INDIVIDUALLY SEALED IN SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temodal 180 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 180 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules in sachets

20 hard capsules in sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the enclosed 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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/019 (5 hard capsules)

EU/1/98/096/020 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 180 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg INDIVIDUALLY SEALED IN SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temodal 250 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 250 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 hard capsules in sachets

20 hard capsules in sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the enclosed 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, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Cytotoxic

Do not open, crush or chew the capsules, swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/021 (5 hard capsules)

EU/1/98/096/022 (20 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temodal 250 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 5 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 5 mg capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 capsule

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 20 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 20 mg capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 capsule

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 100 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 100 mg capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 capsule

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 140 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 140 mg capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 capsule

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 180 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 180 mg capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 capsule

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 250 mg

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Temodal 250 mg capsules temozolomide

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 capsule

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Temodal 2.5 mg/ml powder for solution for infusion temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 100 mg temozolomide.

After reconstitution, 1 ml of solution for infusion contains 2.5 mg temozolomide.

3. LIST OF EXCIPIENTS

Excipients: mannitol (E421), threonine, polysorbate 80, sodium citrate and hydrochloric acid concentrated for pH adjustment.

For sodium, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion 1 vial 100 mg

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use only.

For single use only.

Read the package leaflet before 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

Avoid contact with skin, eyes or nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

After reconstitution, use the solution within 14 hours at 25 C, including infusion time.

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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/023

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Temodal 2.5 mg/ml powder for solution for infusion temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 100 mg temozolomide.

After reconstitution, 1 ml of solution for infusion contains 2.5 mg.

3. LIST OF EXCIPIENTS

Mannitol (E421), threonine, polysorbate 80, sodium citrate and hydrochloric acid. For sodium, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion 100 mg

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, single use only.

Read the package leaflet before 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

Avoid contact with skin, eyes, nose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

After reconstitution: 14 hours at 25 C, including infusion time.

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

Dispose of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/096/023

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

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