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Eptifibatide Accord (eptifibatide) – Labelling - B01AC16

Updated on site: 06-Oct-2017

Medication nameEptifibatide Accord
ATC CodeB01AC16
Substanceeptifibatide
ManufacturerAccord Healthcare Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Eptifibatide Accord 0.75 mg/ml solution for infusion eptifibatide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution for infusion contains 0.75 mg of eptifibatide.

One 100 ml vial contains 75 mg of eptifibatide.

3.LIST OF EXCIPIENTS

Excipients: Citric acid monohydrate, sodium hydroxide, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion

1 vial of 100 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use

Read the package leaflet before 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 a refrigerator(2°C - 8°C).

Store in the original package in order to protect from light.

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)

EU/1/15/1065/001

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 IMMEDIATE PACKAGING UNITS LABEL for 100 ml vial

1. NAME OF THE MEDICINAL PRODUCT

Eptifibatide Accord 0.75 mg/ml solution for infusion

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One 100 ml vial contains 75 mg of eptifibatide.

3. LIST OF EXCIPIENTS

Excipients: Citric acid monohydrate, sodium hydroxide, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion 100 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

I.V. use.

Read the package leaflet before 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 a refrigerator (2°C - 8°C).

Store in the original package in order to protect from light.

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1065/001

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Eptifibatide Accord 2 mg/ml solution for injection eptifibatide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution for injection contains 2 mg of eptifibatide.

One 10 ml vial contains 20 mg of eptifibatide.

3. LIST OF EXCIPIENTS

Excipients: Citric acid monohydrate, sodium hydroxide, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 vial of 10 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use

Read the package leaflet before 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 a refrigerator (2°C - 8°C).

Store in the original package in order to protect from light.

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)

EU/1/15/1065/002

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

LABEL for 10 ml vial

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

Eptifibatide Accord 2 mg/ml solution for injection eptifibatide

Intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

20 mg/10 ml

6.OTHER

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