English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Temomedac (temozolomide) – Labelling - L01AX03

Updated on site: 10-Oct-2017

Medication nameTemomedac
ATC CodeL01AX03
Substancetemozolomide
Manufacturermedac Gesellschaft für klinische Spezialpräparate mbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Temomedac 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 package 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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/605/001

EU/1/09/605/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Temomedac 5 mg

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 OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Temomedac 20 mg hard capsules temozolomide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 20 mg temozolomide.

3. LIST OF EXCIPIENTS

Contains lactose, sunset yellow FCF (E110). 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

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 package 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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/605/003

EU/1/09/605/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temomedac 20 mg

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 OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Temomedac 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 package in order to protect from moisture.

Keep the bottle tightly.

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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/605/005

EU/1/09/605/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temomedac 100 mg

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 OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Temomedac 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 package in order to protect from moisture.

Keep the bottle tightly.

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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/605/007

EU/1/09/605/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temomedac 140 mg

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 OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Temomedac 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 package 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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/605/009

EU/1/09/605/010

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temomedac 180 mg

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 OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Temomedac 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 package 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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/605/011

EU/1/09/605/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Temomedac 250 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

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

Temomedac 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

BOTTLE LABEL

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

Temomedac 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

BOTTLE LABEL

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

Temomedac 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

BOTTLE LABEL

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

Temomedac 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

BOTTLE LABEL

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

Temomedac 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

BOTTLE LABEL

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

Temomedac 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

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed