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Aclasta (zoledronic acid) – Labelling - M05BA08

Updated on site: 05-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON (WITH BLUE BOX) FOR UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Aclasta 5 mg solution for infusion zoledronic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each bottle of 100 ml contains 5 mg zoledronic acid (as monohydrate).

3.LIST OF EXCIPIENTS

Mannitol, sodium citrate and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion

1 bottle of 100 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous 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

After opening: 24 hours at 2°C - 8°C.

9.SPECIAL STORAGE CONDITIONS

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 ofin accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/05/308/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including braille accepted.

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 IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Aclasta 5 mg solution for infusion zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 bottle contains 5 mg zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

Mannitol, sodium citrate and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion

100 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous 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

After opening: 24 hours at 2°C - 8°C.

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/05/308/001

Unit pack

 

EU/1/05/308/002

 

Multipack

 

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including braille accepted.

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING CARTON FOR INTERMEDIATE PACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Aclasta 5 mg solution for infusion zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each bottle of 100 ml contains 5 mg zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

Mannitol, sodium citrate and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion

1 bottle of 100 ml

Component of a multipack. Not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous 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

After opening: 24 hours at 2°C - 8°C.

9. SPECIAL STORAGE CONDITIONS

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/05/308/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including braille accepted.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PARTICULARS TO APPEAR ON THE OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Aclasta 5 mg solution for infusion zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each bottle of 100 ml contains 5 mg zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

Mannitol, sodium citrate and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion

Multipack: 5 bottles, each bottle of 100 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous 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

After opening: 24 hours at 2°C - 8°C.

9. SPECIAL STORAGE CONDITIONS

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/05/308/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

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