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Protelos (strontium ranelate) – Labelling - M05BX03

Updated on site: 09-Oct-2017

Medication nameProtelos
ATC CodeM05BX03
Substancestrontium ranelate
ManufacturerLes Laboratoires Servier

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

1.NAME OF THE MEDICINAL PRODUCT

PROTELOS 2 g granules for oral suspension

Strontium ranelate

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 2 g strontium ranelate.

3.LIST OF EXCIPIENTS

Also contains aspartame (E 951).

4.PHARMACEUTICAL FORM AND CONTENTS

Granules for oral suspension. 7 sachets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

If not used immediately after reconstitution, the preparation should be consumed within 24 hours.

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

Les Laboratoires Servier 50, rue Carnot

92284 Suresnes cedex France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/288/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

PROTELOS 2 g

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

Outer carton

1. NAME OF THE MEDICINAL PRODUCT

PROTELOS 2 g granules for oral suspension

Strontium ranelate

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 2 g strontium ranelate.

3. LIST OF EXCIPIENTS

Also contains aspartame (E 951).

4. PHARMACEUTICAL FORM AND CONTENTS

Granules for oral suspension. 14 sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For 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.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

If not used immediately after reconstitution, the preparation should be consumed within 24 hours.

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

Les Laboratoires Servier 50, rue Carnot

92284 Suresnes cedex France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/288/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PROTELOS 2 g

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

Outer carton

1. NAME OF THE MEDICINAL PRODUCT

PROTELOS 2 g granules for oral suspension

Strontium ranelate

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 2 g strontium ranelate.

3. LIST OF EXCIPIENTS

Also contains aspartame (E 951).

4. PHARMACEUTICAL FORM AND CONTENTS

Granules for oral suspension. 28 sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For 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.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

If not used immediately after reconstitution, the preparation should be consumed within 24 hours.

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

Les Laboratoires Servier 50, rue Carnot

92284 Suresnes cedex France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/288/003

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PROTELOS 2 g

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

Outer carton

1. NAME OF THE MEDICINAL PRODUCT

PROTELOS 2 g granules for oral suspension

Strontium ranelate

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 2 g strontium ranelate.

3. LIST OF EXCIPIENTS

Also contains aspartame (E 951).

4. PHARMACEUTICAL FORM AND CONTENTS

Granules for oral suspension. 56 sachets

84 sachets

100 sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For 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.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

If not used immediately after reconstitution, the preparation should be consumed within 24 hours.

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

Les Laboratoires Servier 50, rue Carnot

92284 Suresnes cedex France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/288/004 56 sachets

EU/1/04/288/005 84 sachets (3 packs of 28)

EU/1/04/288/006 100 sachets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PROTELOS 2 g

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

Sachet

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

PROTELOS 2 g granules for oral suspension.

Strontium ranelate.

For oral use.

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 g

6.OTHER

Read the package leaflet before use

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