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Emend (aprepitant) – Labelling - A04AD12

Updated on site: 06-Oct-2017

Medication nameEmend
ATC CodeA04AD12
Substanceaprepitant
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON OUTER PACKAGING

OUTER PACKAGING – STANDARD PACK (CARTON)

1.NAME OF THE MEDICINAL PRODUCT

EMEND 40 mg hard capsules

Aprepitant

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 40 mg of aprepitant.

3.LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

1 hard capsule

5 x 1 hard capsule

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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 the original package in order to protect from moisture.

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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/03/262/007 1 hard capsule

EU/1/03/262/008 5 x 1 hard capsule

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

EMEND 40 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TEXT

1. NAME OF THE MEDICINAL PRODUCT

EMEND 40 mg hard capsules

Aprepitant

2.NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.OTHER

PARTICULARS TO APPEAR ON OUTER PACKAGING

OUTER PACKAGING – STANDARD PACK (CARTON)

1. NAME OF THE MEDICINAL PRODUCT

EMEND 80 mg hard capsules

Aprepitant

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 80 mg of aprepitant.

3. LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 hard capsule

2-day treatment pack containing: 2 x 80 mg hard capsule 5 x 1 hard capsule

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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 the original package in order to protect from moisture.

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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/262/001 1 hard capsule

EU/1/03/262/002 2 x 1 hard capsule

EU/1/03/262/003 5 x 1 hard capsule

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

EMEND 80 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (INCLUDING 2 HARD CAPSULES 80 MG)

IMMEDIATE PACKAGING – TRIFOLD – 2-day treatment pack

1. NAME OF THE MEDICINAL PRODUCT

EMEND 80 mg hard capsules

Aprepitant

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 80 mg of aprepitant.

3. LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

2-day treatment pack containing:

2 x 80 mg hard capsule

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Please read enclosed leaflet before use.

See enclosed leaflet for additional information about how to take EMEND.

WHEN and HOW to take EMEND

Your doctor has prescribed EMEND, an anti-emetic, to help prevent nausea and vomiting associated with chemotherapy.

HOW:

EMEND 80 mg hard capsules are taken just once a day for 2 consecutive days. EMEND capsules can be taken with or without food.

Do not remove all capsules at one time.

To remove, push capsules through from this side.

Start of Therapy WHEN:

Take one EMEND 80 mg capsule each morning. Start on the day after your chemotherapy.

Day 1

Day 2

EMEND 80 mg capsule

As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 2 consecutive days as prescribed by your doctor.

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 the original package in order to protect from moisture.

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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/262/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TEXT

1. NAME OF THE MEDICINAL PRODUCT

EMEND 80 mg hard capsules

Aprepitant

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER PACKAGING – STANDARD PACK (CARTON)

1. NAME OF THE MEDICINAL PRODUCT

EMEND 125 mg hard capsules

Aprepitant

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 125 mg of aprepitant.

3. LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 hard capsule

5 x 1 hard capsule

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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 the original package in order to protect from moisture.

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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/262/004 1 hard capsule

EU/1/03/262/005 5 x 1 hard capsule

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

EMEND 125 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TEXT

1. NAME OF THE MEDICINAL PRODUCT

EMEND 125 mg hard capsules

Aprepitant

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER PACKAGING – STANDARD PACK (CARTON)

1. NAME OF THE MEDICINAL PRODUCT

EMEND 165 mg hard capsules

Aprepitant

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 165 mg of aprepitant.

3. LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 hard capsule

6 x 1 hard capsule

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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 the original package in order to protect from moisture.

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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/262/009 1 hard capsule

EU/1/03/262/010 6 x 1 hard capsule

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

EMEND 165 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TEXT

1. NAME OF THE MEDICINAL PRODUCT

EMEND 165 mg hard capsules

Aprepitant

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER PACKAGING – TRIFOLD PACK (CARTON) – 3-day treatment pack

1. NAME OF THE MEDICINAL PRODUCT

EMEND 125 mg hard capsule

EMEND 80 mg hard capsules

Aprepitant

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 125 mg hard capsule contains 125 mg of aprepitant.

Each 80 mg hard capsule contains 80 mg of aprepitant.

3. LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

3-day treatment pack containing:

1 x 125 mg hard capsule and

2 x 80 mg hard capsule

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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 the original package in order to protect from moisture.

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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/262/006

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

EMEND 125 mg/80 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (INCLUDING 1 HARD CAPSULE 125 MG AND 2 HARD CAPUSULES 80 MG)

IMMEDIATE PACKAGING – TRIFOLD – 3-day treatment pack

1. NAME OF THE MEDICINAL PRODUCT

EMEND 125 mg hard capsule

EMEND 80 mg hard capsules

Aprepitant

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 125 mg hard capsule contains 125 mg of aprepitant.

Each 80 mg hard capsule contains 80 mg of aprepitant.

3. LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

3-day treatment pack containing:

1 x 125 mg hard capsule and

2 x 80 mg hard capsule

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Please read enclosed leaflet before use.

See enclosed leaflet for additional information about how to take EMEND.

WHEN and HOW to take EMEND

Your doctor has prescribed EMEND, an anti-emetic, to help prevent nausea and vomiting associated with chemotherapy.

HOW:

EMEND is taken just once a day for 3 consecutive days.

EMEND capsules can be taken with or without food.

Do not remove all capsules at one time.

To remove, push capsules through from this side.

Start of Therapy WHEN:

Take one EMEND 125 mg capsule by mouth 1-hour BEFORE you start your chemotherapy treatment.

Day 1

EMEND 125 mg capsule

WHEN:

Take one EMEND 80 mg capsule each morning on the next two days.

Day 2

Day 3

EMEND 80 mg capsule

As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 3 consecutive days as prescribed by your doctor.

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 the original package in order to protect from moisture.

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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/262/006

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON EMEND 125 mg powder for oral suspension

1. NAME OF THE MEDICINAL PRODUCT

EMEND 125 mg powder for oral suspension

Aprepitant

For children aged 6 months to less than 12 years

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains125 mg of aprepitant. After reconstitution, 1 mL of oral suspension contains 25 mg of aprepitant.

3. LIST OF EXCIPIENTS

Contains sucrose and lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension.

One sachet, two oral dispensers, one cap and one mixing cup.

5.METHOD AND ROUTES OF ADMINISTRATION

Read the package leaflet before use.

Oral 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 the original package in order to protect from moisture.

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

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/262/011

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

EMEND 125 mg powder for oral suspension

PARTICULARS TO APPEAR ON THE SMALL IMMEDIATE PACKAGING Sachet for EMEND 125 mg powder for oral suspension

1. NAME OF THE MEDICINAL PRODUCT

EMEND 125 mg powder for oral suspension

Aprepitant

Oral use

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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