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

Renvela (sevelamer carbonate) – Labelling - V03AE02

Updated on site: 09-Oct-2017

Medication nameRenvela
ATC CodeV03AE02
Substancesevelamer carbonate
ManufacturerGenzyme Europe B.V.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL - BOTTLE OF 30 TABLETS (WITH OUTER CARTON)

LABEL with Blue box - BOTTLE OF 180 TABLETS (WITHOUT OUTER CARTON)

1.NAME OF THE MEDICINAL PRODUCT

Renvela 800 mg film-coated tablets sevelamer carbonate

2.STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 800 mg sevelamer carbonate.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

180 film-coated tablets

5.METHOD AND ROUTE OF ADMINISTRATION

For oral use.

Tablets must be swallowed whole. Do not chew.

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, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Keep the bottle 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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

12.MARKETING AUTHORISATION NUMBERS

EU/1/09/521/001 30 film-coated tablets

EU/1/09/521/003 180 film-coated tablets

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renvela 800 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON with Blue box – BOTTLE OF 30 TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Renvela 800 mg film-coated tablets sevelamer carbonate

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 800 mg sevelamer carbonate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

5. METHOD AND ROUTE OF ADMINISTRATION

For oral use.

Tablets must be swallowed whole. Do not chew.

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, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep bottle 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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/09/521/001

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Renvela 800 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL - BOTTLE OF 30 TABLETS (MULTIPACK PRESENTATION)

1. NAME OF THE MEDICINAL PRODUCT

Renvela 800 mg film-coated tablets sevelamer carbonate

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 800 mg sevelamer carbonate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets. Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE OF ADMINISTRATION

For oral use.

Tablets must be swallowed whole. Do not chew.

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, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the bottle 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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/09/521/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Renvela 800 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON with Blue Box – MULTIPACK OF 180 (6 BOTTLES OF 30) TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Renvela 800 mg film-coated tablets sevelamer carbonate

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 800 mg sevelamer carbonate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

180 (6 bottles of 30) film-coated tablets

5. METHOD AND ROUTE OF ADMINISTRATION

For oral use.

Tablets must be swallowed whole. Do not chew.

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, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep bottle 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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/09/521/002 180 (6 bottles of 30) film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Renvela 800 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON - CARTON OF 60 or 90 SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Renvela 1.6 g powder for oral suspension sevelamer carbonate

2. STATEMENT OF ACTIVE SUBSTANCE

Each sachet contains 1.6 g sevelamer carbonate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension 60 sachets

90 sachets

5. METHOD AND ROUTE 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, IF NECESSARY

8. EXPIRY DATE

EXP

The reconstituted suspension must be administered within 30 minutes of reconstitution.

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/09/521/004

EU/1/09/521/005

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Renvela 1.6 g

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL - SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Renvela 1.6 g powder for oral suspension sevelamer carbonate

2. STATEMENT OF ACTIVE SUBSTANCE

Each sachet contains 1.6 g sevelamer carbonate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension

1.6 g powder

5. METHOD AND ROUTE 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, IF NECESSARY

8. EXPIRY DATE

EXP

The reconstituted suspension must be administered within 30 minutes of reconstitution.

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/09/521/004

EU/1/09/521/005

13. BATCH NUMBER

Batch

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 OUTER PACKAGING

OUTER CARTON - CARTON OF 60 or 90 SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Renvela 2.4 g powder for oral suspension sevelamer carbonate

2. STATEMENT OF ACTIVE SUBSTANCE

Each sachet contains 2.4 g sevelamer carbonate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension 60 sachets

90 sachets

5. METHOD AND ROUTE 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, IF NECESSARY

8. EXPIRY DATE

EXP

The reconstituted suspension must be administered within 30 minutes of reconstitution.

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/09/521/006

EU/1/09/521/007

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Renvela 2.4 g

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL - SACHETS

1. NAME OF THE MEDICINAL PRODUCT

Renvela 2.4 g powder for oral suspension sevelamer carbonate

2. STATEMENT OF ACTIVE SUBSTANCE

Each sachet contains 2.4 g sevelamer carbonate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension

2.4 g powder

5. METHOD AND ROUTE 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, IF NECESSARY

8. EXPIRY DATE

EXP

The reconstituted suspension must be administered within 30 minutes of reconstitution.

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

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/09/521/006

EU/1/09/521/007

13. BATCH NUMBER

Batch

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.

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