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Zoledronic acid medac (zoledronic acid monohydrate) – Labelling - M05BA08

Updated on site: 11-Oct-2017

Medication nameZoledronic acid medac
ATC CodeM05BA08
Substancezoledronic acid monohydrate
Manufacturermedac Gesellschaft für klinische Spezialpräparate mbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR 1 VIAL

CARTON FOR 4 VIALS

1.NAME OF THE MEDICINAL PRODUCT

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

Zoledronic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

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

3.LIST OF EXCIPIENTS

Excipients: mannitol, sodium citrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion. 1 vial

4 vials

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Dilute before use.

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:

Read the leaflet for the shelf life of the diluted medicine.

9.SPECIAL STORAGE CONDITIONS

Do not freeze.

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

medac GmbH Theaterstr. 6 22880 Wedel Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/779/001<1 vial>

EU/1/12/779/007<4 vials>

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.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX)

CARTON FOR 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS CARTON FOR 1 VIAL AS PART OF A MULTIPACK COMPRISING 10 VIALS

1. NAME OF THE MEDICINAL PRODUCT

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

Zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

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

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium citrate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion.

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

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Dilute before use.

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:

Read the leaflet for the shelf life of the diluted medicine.

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

medac GmbH Theaterstr. 6 22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/779/002

EU/1/12/779/003

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

VIAL LABEL

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

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

Zoledronic acid

Intravenous use.

2.METHOD OF ADMINSTRATION

Dilute before use.

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

Read the package leaflet before use.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

LABEL ON MULTIPACKS WITH 4 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)

LABEL ON MULTIPACKS WITH 10 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

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

Zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

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

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium citrate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion.

Multipack: 4 x 1 vial

Multipack: 10 x 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Dilute before use.

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:

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

medac GmbH Theaterstr. 6 22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/779/002

EU/1/12/779/003

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.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR 1 BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Zoledronic acid medac 4 mg/100 ml solution for infusion

Zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One bottle contains 4 mg of zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium citrate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion. 1 bottle

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:

Read the leaflet for the shelf life of the medicine after first opening.

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

medac GmbH Theaterstr. 6 22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/779/004

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.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX)

CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 4 BOTTLES CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 10 BOTTLES

1. NAME OF THE MEDICINAL PRODUCT

Zoledronic acid medac 4 mg/100 ml solution for infusion

Zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One bottle contains 4 mg of zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium citrate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion.

1 bottle. 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.

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 leaflet for the shelf life of the medicine after first opening.

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

medac GmbH Theaterstr. 6 22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/779/005

EU/1/12/779/006

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.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Zoledronic acid medac 4 mg/100 ml solution for infusion

Zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One bottle contains 4 mg of zoledronic acid (as monohydrate).

One ml solution contains 0.04 mg zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium citrate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion.

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:

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

medac GmbH Theaterstr. 6 22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/779/004

EU/1/12/779/005

EU/1/12/779/006

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

LABEL ON MULTIPACKS WITH 4 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)

LABEL ON MULTIPACKS WITH 10 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Zoledronic acid medac 4 mg/100 ml solution for infusion

Zoledronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One bottle contains 4 mg of zoledronic acid (as monohydrate).

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium citrate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion.

Multipack: 4 x 1 bottle

Multipack: 10 x 1 bottle

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:

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

medac GmbH Theaterstr. 6 22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/779/005

EU/1/12/779/006

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.

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