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Optimark (gadoversetamide) – Labelling - V08CA06

Updated on site: 09-Oct-2017

Medication nameOptimark
ATC CodeV08CA06
Substancegadoversetamide
ManufacturerMallinckrodt Deutschland GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Text for the outer packaging of 10 ml, 15 ml, 20 ml and 30 ml pre-filled syringes

1.NAME OF THE MEDICINAL PRODUCT

Optimark 500 micromol/ml solution for injection in pre-filled syringe

Gadoversetamide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.

3.LIST OF EXCIPIENTS

Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.

Please see package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled syringe 10 ml (1, 10 syringes)

15 ml (1, 10 syringes)

20 ml (1, 10 syringes)

30 ml (1, 10 syringes)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

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

Contrast medium for magnetic resonance imaging

For recording: stick the peel-off tracking label onto the patient record. For electronic records: enter product name, batch no. and dose.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Keep the syringe in the outer carton in order to protect from light.

Do not refrigerate or freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

For single use only. Discard any remaining solution after first use.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Guerbet, 15, rue des Vanesses, 93420 Villepinte, France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/398/007 (1 x 10 ml)

EU/1/07/398/008 (10 x 10 ml)

EU/1/07/398/009 (1 x 15 ml)

EU/1/07/398/010 (10 x 15 ml)

EU/1/07/398/011 (1 x 20 ml)

EU/1/07/398/012 (10 x 20 ml)

EU/1/07/398/013 (1 x 30 ml)

EU/1/07/398/014 (10 x 30 ml)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

17.UNIQUE IDENTIFIER – 2D BARCODE

Not applicable.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes

1. NAME OF THE MEDICINAL PRODUCT

Optimark 500 micromol/ml solution for injection in pre-filled syringe

Gadoversetamide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.

3. LIST OF EXCIPIENTS

Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled syringe

15 ml

20 ml

30 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

This sticky label should be stuck on patient records.

For electronic records: enter product name, batch no. and dose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the syringe in the outer carton in order to protect from light.

Do not refrigerate or freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

For single use only. Discard any remaining solution after first use.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Guerbet, 15, rue des Vanesses, 93420 Villepinte, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/398/007 (1 x 10 ml)

EU/1/07/398/008 (10 x 10 ml)

EU/1/07/398/009 (1 x 15 ml)

EU/1/07/398/010 (10 x 15 ml)

EU/1/07/398/011 (1 x 20 ml)

EU/1/07/398/012 (10 x 20 ml)

EU/1/07/398/013 (1 x 30 ml)

EU/1/07/398/014 (10 x 30 ml)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

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

Text for the immediate packaging of the 10 ml pre-filled syringe

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

Optimark 500 micromol/ml solution for injection in pre-filled syringe

Gadoversetamide

IV use.

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

6.OTHER

Keep the syringe in the outer carton in order to protect from light.

Do not refrigerate or freeze.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Text for the outer packaging of 10 ml, 15 ml and 20 ml vials

1. NAME OF THE MEDICINAL PRODUCT

Optimark 500 micromol/ml solution for injection in vial

Gadoversetamide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.

3. LIST OF EXCIPIENTS

Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in vial 10 ml (1, 10 vials)

15 ml (1, 10 vials)

20 ml (1, 10 vials)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

Contrast medium for magnetic resonance imaging

For recording: stick the peel-off tracking label onto the patient record. For electronic records: enter product name, batch no. and dose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the vial in the outer carton in order to protect from light.

Do not refrigerate or freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

For single use only. Discard any remaining solution after first use.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Guerbet, 15, rue des Vanesses, 93420 Villepinte, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/398/001 (1 x 10 ml)

EU/1/07/398/002 (10 x 10 ml)

EU/1/07/398/003 (1 x 15 ml)

EU/1/07/398/004 (10 x 15 ml)

EU/1/07/398/005 (1 x 20 ml)

EU/1/07/398/006 (10 x 20 ml)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

Text for the immediate packaging of 15 ml and 20 ml vials

1. NAME OF THE MEDICINAL PRODUCT

Optimark 500 micromol/ml solution for injection in vial

Gadoversetamide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.

3. LIST OF EXCIPIENTS

Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in vial 15 ml

20 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

This sticky label should be stuck on patient records.

For electronic records: enter product name, batch no. and dose.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the vial in the outer carton in order to protect from light.

Do not refrigerate or freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

For single use only. Discard any remaining solution after first use.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Guerbet, 15, rue des Vanesses, 93420 Villepinte, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/398/001 (1 x 10 ml)

EU/1/07/398/002 (10 x 10 ml)

EU/1/07/398/003 (1 x 15 ml)

EU/1/07/398/004 (10 x 15 ml)

EU/1/07/398/005 (1 x 20 ml)

EU/1/07/398/006 (10 x 20 ml)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

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

Text for the immediate packaging of the 10 ml vial

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

Optimark 500 micromol/ml solution for injection in vial

Gadoversetamide

IV use.

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

6. OTHER

Keep the vial in the outer carton in order to protect from light.

Do not refrigerate or freeze.

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