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Bondronat (ibandronic acid) – Labelling - M05BA06

Updated on site: 05-Oct-2017

Medication nameBondronat
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerRoche Registration Ltd.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1.NAME OF THE MEDICINAL PRODUCT

Bondronat 2 mg concentrate for solution for infusion ibandronic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 2 mg of ibandronic acid (as sodium monohydrate).

3.LIST OF EXCIPIENTS

Sodium acetate, sodium chloride, acetic acid and water for injections. See the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Intravenous use, for infusion after dilution

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

This medicinal product does not require any special storage conditions prior to reconstitution. After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/96/012/004

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

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

Vial

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

Bondronat 2 mg concentrate for solution for infusion ibandronic acid

I.V. use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Bondronat 50 mg film-coated tablets ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).

3. LIST OF EXCIPIENTS

The tablets also contain lactose monohydrate. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

28 film-coated tablets

84 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not suck, chew or crush tablets

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

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package 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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/012/009: 28film-coated tablets

EU/1/96/012/010: 84 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

bondronat 50 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 BLISTERS OR STRIPS Blister foil

1. NAME OF THE MEDICINAL PRODUCT

Bondronat 50 mg film-coated tablets ibandronic acid

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Roche Registration Ltd.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.OTHER

Mon

Tue

Wed

Thu

Fri

Sat

Sun

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Bondronat 6 mg concentrate for solution for infusion ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).

3. LIST OF EXCIPIENTS

Sodium acetate, sodium chloride, acetic acid and water for injections. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 1 vial

5 vials

10 vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Intravenous use, for infusion after dilution

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

This medicinal product does not require any special storage conditions prior to reconstitution. After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/012/011: 1 vial

EU/1/96/012/012: 5 vials

EU/1/96/012/013: 10 vials

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

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

Vial

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

Bondronat 6 mg concentrate for solution for infusion ibandronic acid

I.V. use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6 ml

6. OTHER

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