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Temozolomide Sandoz (temozolomide) – Labelling - L01AX03

Updated on site: 10-Oct-2017

Medication nameTemozolomide Sandoz
ATC CodeL01AX03
Substancetemozolomide
ManufacturerSandoz GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING BOTTLE

1.NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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

Oral use

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

7.OTHER SPECIAL WARNING, 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 25°C

Store in the original package.

Keep the bottles tightly closed in order to protect from moisture.

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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/001

EU/1/10/617/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Temozolomide Sandoz 5 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°C

Store in the original package.

Keep the bottles tightly closed in order to protect from moisture.

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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/005

EU/1/10/617/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 20 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°C

Store in the original package.

Keep the bottles tightly closed in order to protect from moisture.

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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/009

EU/1/10/617/010

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°C

Store in the original package.

Keep the bottles tightly closed in order to protect from moisture.

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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/013

EU/1/10/617/014

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 140 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°C

Store in the original package.

Keep the bottles tightly closed in order to protect from moisture.

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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/017

EU/1/10/617/018

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 180 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°C

Store in the original package.

Keep the bottles tightly closed in order to protect from moisture.

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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/021

EU/1/10/617/022

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 250 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

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

Temozolomide Sandoz 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

5 capsules

20 capsules

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

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

Temozolomide Sandoz 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

5 capsules

20 capsules

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

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

Temozolomide Sandoz 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

5 capsules

20 capsules

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

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

Temozolomide Sandoz 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

5 capsules

20 capsules

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

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

Temozolomide Sandoz 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

5 capsules

20 capsules

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

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

Temozolomide Sandoz 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

5 capsules

20 capsules

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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 x 1 hard capsule in sachet

20 x 1 hard capsule in sachet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/025

EU/1/10/617/026

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 5 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandozl 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 x 1 hard capsule in sachet

20 x 1 hard capsule in sachet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/027

EU/1/10/617/028

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 20 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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 x 1 hard capsule in sachet

20 x 1 hard capsule in sachet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/029

EU/1/10/617/030

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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 x 1 hard capsule in sachet

20 x 1 hard capsule in sachet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/031

EU/1/10/617/032

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 140 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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 x 1 hard capsule in sachet

20 x 1 hard capsule in sachet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/616/033

EU/1/10/616/034

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 180 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Temozolomide Sandoz 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 x 1 hard capsule in sachet

20 x 1 hard capsule in sachet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

7. OTHER SPECIAL WARNING, 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 25°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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/617/035

EU/1/10/617/036

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temozolomide Sandoz 250 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: { number}

SN: { number}

NN: { number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL

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

Temozolomide Sandoz 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 LABEL

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

Temozolomide Sandoz 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 LABEL

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

Temozolomide Sandoz 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 LABEL

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

Temozolomide Sandoz 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 LABEL

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

Temozolomide Sandoz 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 LABEL

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

Temozolomide Sandoz 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

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