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Ibandronic acid Accord (ibandronic acid) – Labelling - M05BA06

Updated on site: 07-Oct-2017

Medication nameIbandronic acid Accord
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerAccord Healthcare Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1.NAME OF THE MEDICINAL PRODUCT

Ibandronic acid Accord 2 mg concentrate for solution for infusion ibandronic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 2 mg of ibandronic acid (as 2.25 mg ibandronate sodium monohydrate).

3.LIST OF EXCIPIENTS

Sodium chloride, sodium acetate trihydrate, glacial 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 (2 mg/2 ml)

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

Read the package leaflet for the shelf life after dilution.

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

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

1 vial: EU/1/12/798/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

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

Ibandronic acid Accord 2 mg sterile concentrate ibandronic acid

I.V. use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP:

4.BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 mg/2 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 6 mg of ibandronic acid (as 6.75 mg ibandronate sodium monohydrate).

3. LIST OF EXCIPIENTS

Sodium chloride, sodium acetate trihydrate, glacial 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 (6 mg/6 ml)

5 vials (6 mg/6 ml)

10 vials (6 mg/6 ml)

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:

Read the package leaflet for the shelf life after dilution.

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

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

1 vial: EU/1/12/798/002

5 vials: EU/1/12/798/003

10 vials: EU/1/12/798/004

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

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

Ibandronic acid Accord 6 mg sterile concentrate ibandronic acid

I.V. use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6 mg/6 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe

Ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as sodium monohydrate).

3. LIST OF EXCIPIENTS

Excipients: sodium chloride, acetic acid, glacial, sodium acetate trihydrate and water for injections. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 pre-filled syringe + 1 injection needle

4 pre-filled syringes + 4 injection needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use only.

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

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

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

1 pre-filled syringe: EU/1/12/798/005

4 pre-filled syringe: EU/1/12/798/006

13. BATCH NUMBER

Lot:

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]

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Ibandronic acid Accord 3 mg injection

Ibandronic acid

I.V.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

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