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Zoledronic acid Mylan (zoledronic acid) – Labelling - M05BA08

Updated on site: 11-Oct-2017

Medication nameZoledronic acid Mylan
ATC CodeM05BA08
Substancezoledronic acid
ManufacturerMylan S.A.S.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1 VIAL

BOX OF 4 VIALS

BOX OF 10 VIALS

1.NAME OF THE MEDICINAL PRODUCT

Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion

Zoledronic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One vial contains 4 mg zoledronic acid (as monohydrate).

3.LIST OF EXCIPIENTS

It also contains sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

1 vial of 5 ml

4 vials of 5 ml

10 vials of 5 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous use 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

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

Mylan S.A.S.

117 Allée des Parcs

69800 Saint Priest France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/786/001

1 vial

 

 

EU/1/12/786/002

4 vials

 

EU/1/12/786/003

10 vials

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 OUTER PACKAGING (WITHOUT BLUE BOX) BOX OF 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS

1. NAME OF THE MEDICINAL PRODUCT

Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion

Zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial contains 4 mg zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

It also contains sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

1 vial of 5 ml. Component of a multipack. Can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous use 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

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

Mylan S.A.S.

117 Allée des Parcs

69800 Saint Priest France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/786/004

Multipack: 4 vials (4 packs of 1)

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 (INCLUDING BLUE BOX)

LABEL FOR MULTIPACK OF 4 VIALS (4 PACKS OF 1) WRAPPED IN TRANSPARENT FOIL

1. NAME OF THE MEDICINAL PRODUCT

Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion

Zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial contains 4 mg zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

It also contains sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

Multipack: 4 (4 packs of 1) vials of 5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous use 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

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

Mylan S.A.S.

117 Allée des Parcs

69800 Saint Priest France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/786/004

Multipack: 4 vials (4 packs of 1)

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:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion

Zoledronic acid

Intravenous use after dilution.

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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