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Renagel (sevelamer) – Labelling - V03AE02

Updated on site: 09-Oct-2017

Medication nameRenagel
ATC CodeV03AE02
Substancesevelamer
ManufacturerGenzyme Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – 1 BOTTLE OF 360 TABLETS 400 mg

1.NAME OF THE MEDICINAL PRODUCT

Renagel 400 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 400 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

360 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/005

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 400 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON with the Blue Box – MULTIPACK OF 720 (2 BOTTLES OF 360) TABLETS 400 mg

OUTER CARTON with the Blue Box – MULTIPACK OF 1080 (3 BOTTLES OF 360) TABLETS 400 mg

1.NAME OF THE MEDICINAL PRODUCT

Renagel 400 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 400 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Multipack: 720 (2 bottles of 360) film-coated tablets.

Multipack: 1080 (3 bottles of 360) film-coated tablets.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/006 multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) EU/1/99/123/007 multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 400 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 360 TABLETS 400 mg

1.NAME OF THE MEDICINAL PRODUCT

Renagel 400 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 400 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

360 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/005

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 400 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL without Blue Box - BOTTLE OF 360 TABLETS 400 mg (MULTIPACK PRESENTATION)

1.NAME OF THE MEDICINAL PRODUCT

Renagel 400 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 400 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

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

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/006 multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) EU/1/99/123/007 multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 400 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON with Blue Box – MULTIPACK OF 180 (6 BOTTLES OF 30) TABLETS 800 mg

1.NAME OF THE MEDICINAL PRODUCT

Renagel 800 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 800 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Multipack: 180 (6 bottles of 30) film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/013

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 800 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – 1 BOTTLE OF 100 TABLETS 800 mg

OUTER CARTON – 1 BOTTLE OF 180 TABLETS 800 mg

1.NAME OF THE MEDICINAL PRODUCT

Renagel 800 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 800 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

100 film-coated tablets

180 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/011 1 bottle of 100 film-coated tablets

EU/1/99/123/008 1 bottle of 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

Renagel 800 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON with Blue Box - MULTIPACK OF 360 (2 BOTTLES OF 180) TABLETS 800 mg

OUTER CARTON with Blue Box - MULTIPACK OF 540 (3 BOTTLES OF 180) TABLETS 800 mg

1.NAME OF THE MEDICINAL PRODUCT

Renagel 800 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 800 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Multipack: 360 (2 bottles of 180) film-coated tablets

Multipack: 540 (3 bottles of 180) film-coated tablets.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/009 multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) EU/1/99/123/010 multipacks containing 540 film-coated tablets (3 bottles of 180 tablets)

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 800 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL without Blue Box - BOTTLE OF 30 TABLETS 800 mg (MULTIPACK PRESENTATION)

1.NAME OF THE MEDICINAL PRODUCT

Renagel 800 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 800 mg sevelamer hydrochloride.

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(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/013

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 800 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL – BOTTLE OF 100 TABLETS 800 mg

LABEL - BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON

LABEL with Blue Box – 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Renagel 800 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 800 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

100 film-coated tablets

180 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/011 1 bottle of 100 film-coated tablets

EU/1/99/123/008 1 bottle of 180 film-coated tablets with outer carton

EU/1/99/123/012 1 bottle of 180 film-coated tablets without outer carton

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 800 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

LABEL without Blue Box – BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON (MULTIPACK PRESENTATION)

1.NAME OF THE MEDICINAL PRODUCT

Renagel 800 mg film-coated tablets sevelamer hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 800 mg sevelamer hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

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

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Tablets must be swallowed whole. Do not chew.

Read the package leaflet before use.

For 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.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C.

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 NUMBER(S)

EU/1/99/123/009 multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) EU/1/99/123/010 multipacks containing 540 film-coated tablets (3 bottles of 180 tablets)

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Renagel 800 mg

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