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Benepali (etanercept) – Labelling - L04AB01

Updated on site: 05-Oct-2017

Medication nameBenepali
ATC CodeL04AB01
Substanceetanercept
ManufacturerSamsung Bioepis UK Limited 5th Floor Profile West 950 Great West Road Brentford TW8 9ES United Kingdom

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON (25 mg PRE-FILLED SYRINGE)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 25 mg solution for injection in pre-filled syringe etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe contains 25 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

4 pre-filled syringes

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

Pull to open

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. Do not freeze.

Keep the pre-filled syringes in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 25 mg

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

MULTIPACKS OF 8 AND 24 (WITH BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 25 mg solution for injection in pre-filled syringe etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe contains 25 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

Multipack: 8 (2 packs of 4) pre-filled syringes

Multipack: 24 (6 packs of 4) pre-filled syringes

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous 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. Do not freeze.

Keep the pre-filled syringes in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/006 multipack of 8 pre-filled syringes (2 packs of 4)

EU/1/15/1074/007 multipack of 24 pre-filled syringes (6 packs of 4)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 25 mg

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

INTERMEDIATE CARTON WITHIN MULTIPACK (4 PRE-FILLED SYRINGES) (WITHOUT BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 25 mg solution for injection in pre-filled syringe etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe contains 25 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

4 pre-filled syringes

Component of a multipack, cannot be sold separately.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

Pull to open

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. Do not freeze.

Keep the pre-filled syringes in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/006 multipack of 8 pre-filled syringes (2 packs of 4)

EU/1/15/1074/007 multipack of 24 pre-filled syringes (6 packs of 4)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 25 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL (25 mg PRE-FILLED SYRINGE)

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

Benepali 25 mg injection etanercept

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

25 mg/0.5 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON (50 mg PRE-FILLED SYRINGE)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 50 mg solution for injection in pre-filled syringe etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe contains 50 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

4 pre-filled syringes

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

Pull to open

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. Do not freeze.

Keep the pre-filled syringes in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 50 mg

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

MULTIPACK OF 12 (3 PACKS OF 4 PRE-FILLED SYRINGES) (WITH BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 50 mg solution for injection in pre-filled syringe etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe contains 50 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

Multipack: 12 (3 packs of 4) pre-filled syringes

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous 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. Do not freeze.

Keep the pre-filled syringes in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 50 mg

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

INTERMEDIATE CARTON WITHIN MULTIPACK (4 PRE-FILLED SYRINGES) (WITHOUT BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 50 mg solution for injection in pre-filled syringe etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe contains 50 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

4 pre-filled syringes

Component of a multipack, cannot be sold separately

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

Pull to open

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. Do not freeze.

Keep the pre-filled syringes in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 50 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL (50 mg PRE-FILLED SYRINGE)

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

Benepali 50 mg injection etanercept

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 mg/1 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON (50 mg PRE-FILLED PEN)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 50 mg solution for injection in pre-filled pen etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each pen contains 50 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

4 pre-filled pens

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

Pull to open

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.

Do not freeze.

Keep the pre-filled pens in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 50 mg

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

MULTIPACK OF 12 (3 PACKS OF 4 PRE-FILLED PENS) (WITH BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 50 mg solution for injection in pre-filled pen etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each pen contains 50 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

Multipack: 12 (3 packs of 4) pre-filled pens

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous 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.

Do not freeze.

Keep the pre-filled pens in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/004

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 50 mg

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

INTERMEDIATE CARTON WITHIN MULTIPACK (4 PRE-FILLED PENS) (WITHOUT BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Benepali 50 mg solution for injection in pre-filled pen etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each pen contains 50 mg etanercept.

3.LIST OF EXCIPIENTS

Excipients:

Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

4 pre-filled pens

Component of a multipack, cannot be sold separately

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

Pull to open

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.

Do not freeze.

Keep the pre-filled pens in the outer carton 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

Samsung Bioepis UK Limited 5th floor

Profile West

950 Great West Road Brentford Middlesex TW8 9ES United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1074/004

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Benepali 50 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL (50 mg PRE-FILLED PEN)

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

Benepali 50 mg solution for injection in pre-filled pen etanercept

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 mg/1 ml

6.OTHER

Patient Alert Card

Benepali

Etanercept

This card contains important safety information that you need to be aware of before you are given Benepali and during treatment with Benepali. If you do not understand this information, please ask your doctor to explain it to you.

Show this card to any doctor involved in your or your child’s treatment.

Use in children and adolescents

Benepali is not indicated for use in children and adolescents weighing less than 62.5 kg. Please ask your doctor if you have any questions about this.

Infections

Benepali may increase your risk of getting infections, which could be serious.

You should not use Benepali if you have an infection. If you are not sure, ask your doctor.

If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.

You should be evaluated for tuberculosis (TB). Ask your doctor to record the dates and the results of your last screening for TB below:

Test:

 

 

Test:

 

 

Date:

 

 

Date:

 

 

Results:

 

 

Results:

 

 

Please ask your physician to list your other medicines that may increase your risk of infection.

Congestive heart failure

If you have congestive heart failure, and you think your symptoms (e.g., shortness of breath or swelling of the feet) are becoming worse, or you experience new onset of such symptoms, seek medical attention immediately.

Other information (please complete)

Patient’s name:

Doctor’s name:

Doctor’s phone:

Keep this card with you for 2 months after the last Benepali dose, since side effects may occur after your last dose of Benepali.

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