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Accofil (filgrastim) – Labelling - L03AA02

Updated on site: 05-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1.NAME OF THE MEDICINAL PRODUCT

Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe in 0.5 ml contains 30 MU of filgrastim (0.6 mg/ml).

3.LIST OF EXCIPIENTS

Acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injection.

4.PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe (0.5 ml) + 1 alcohol swab

“5 pre-filled syringes (0.5 ml) + 5 alcohol swabs” “3 pre-filled syringe (0.5 ml) + 3 alcohol swabs” “10 pre-filled syringe (0.5 ml) + 10 alcohol swabs”

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Subcutaneous or intravenous use.

Do not shake

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 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 syringe 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

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/946/001 - 1 prefilled syringe

EU/1/14/946/002 - 5 prefilled syringes

EU/1/14/946/006 - 3 prefilled syringe

EU/1/14/946/009 - 10 prefilled syringe

13. BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Accofil 30 MU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton – Pre-filled syringe with a needle safety guard in blister pack

1. NAME OF THE MEDICINAL PRODUCT

Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe in 0.5 ml contains 30 MU of filgrastim (0.6 mg/ml).

3. LIST OF EXCIPIENTS

Acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe (0.5 ml) + 1 alcohol swab “3 pre-filled syringe (0.5 ml) + 3 alcohol swabs”

“5 pre-filled syringes (0.5 ml) + 5 alcohol swabs” “10 pre-filled syringe (0.5 ml) + 10 alcohol swabs” “7 pre-filled syringe (0.5 ml) + 7 alcohol swabs”

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Subcutaneous or intravenous use.

Do not shake

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 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 syringe 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

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/946/005 – 1 prefilled syringe with a needle safety guard

EU/1/14/946/008 – 5 prefilled syringes with a needle safety guard

EU/1/14/946/007 – 3 prefilled syringe with a needle safety guard

EU/1/14/946/010 – 10 prefilled syringe with a needle safety guard

EU/1/14/946/017 – 7 prefilled syringe with a needle safety guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Accofil 30 MU/0.5 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim

SC/IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Accofil 48 MU/0.5 ml solution for injection/infusion filgrastim

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe in 0.5 ml contains 48 MU of filgrastim (0.96 mg/ml).

3. LIST OF EXCIPIENTS

Acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe (0.5 ml) + 1 alcohol swab

“5 pre-filled syringes (0.5 ml) + 5 alcohol swabs” “3 pre-filled syringe (0.5 ml) + 3 alcohol swabs” “10 pre-filled syringe (0.5 ml) + 10 alcohol swabs”

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Subcutaneous or intravenous use.

Do not shake.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 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 syringe 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

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/946/003 - 1 prefilled syringe

EU/1/14/946/004 - 5 prefilled syringes

EU/1/14/946/012 - 3 prefilled syringe

EU/1/14/946/015 - 10 prefilled syringe

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Accofil 48 MU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton – Pre-filled syringe with a needle safety guard in blister pack

1. NAME OF THE MEDICINAL PRODUCT

Accofil 48 MU/0.5 ml solution for injection/infusion filgrastim

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each syringe in 0.5 ml contains 48 MU of filgrastim (0.96 mg/ml).

3. LIST OF EXCIPIENTS

Acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe (0.5 ml) + 1 alcohol swab “3 pre-filled syringe (0.5 ml) + 3 alcohol swabs”

“5 pre-filled syringes (0.5 ml) + 5 alcohol swabs” “10 pre-filled syringe (0.5 ml) + 10 alcohol swabs” “7 pre-filled syringe (0.5 ml) + 7 alcohol swabs”

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Subcutaneous or intravenous use.

Do not shake.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 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 syringe 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

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/946/011 – 1 prefilled syringe with a needle safety guard

EU/1/14/946/014 – 5 prefilled syringes with a needle safety guard

EU/1/14/946/013 – 3 prefilled syringe with a needle safety guard

EU/1/14/946/016 – 10 prefilled syringe with a needle safety guard

EU/1/14/946/018 – 7 prefilled syringe with a needle safety guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Accofil 48 MU/0.5 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Accofil 48 MU/0.5 ml solution for injection/infusion filgrastim

SC/IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

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