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Abilify Maintena (aripiprazole) – Labelling - N05AX12

Updated on site: 05-Oct-2017

Medication nameAbilify Maintena
ATC CodeN05AX12
Substancearipiprazole
ManufacturerOtsuka Pharmaceutical Europe Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton - Single pack 300 mg

1.NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection aripiprazole

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 300 mg aripiprazole.After reconstitution each ml of suspension contains 200 mg aripiprazole.

3.LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

One vial of powder

One vial of 2 ml solvent

Two sterile syringes, one with needle for reconstitution

Three hypodermic safety needles

One vial adapter

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection.

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

Shelf-life after reconstitution: 4 hours below 25 °C

9.SPECIAL STORAGE CONDITIONS

Do not freeze.

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

Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/001

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 THE OUTER PACKAGING

Outer carton - Single pack 400 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 400 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

One vial of powder

One vial of 2 ml solvent

Two sterile syringes, one with needle for reconstitution

Three hypodermic safety needles

One vial adapter

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection.

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

Shelf-life after reconstitution: 4 hours below 25 °C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/002

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.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer label (with blue box) - Multipack 300 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 300 mg aripiprazole.After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: Three single packages, each containing:

One vial of powder

One vial of 2 ml solvent

Two sterile syringes, one with needle for reconstitution

Three hypodermic safety needles

One vial adapter

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection.

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

Shelf-life after reconstitution: 4 hours below 25 °C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/003

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 THE OUTER PACKAGING

Carton (without blue box) – component of multipack 300 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 300 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Single package containing:

One vial of powder

One vial of 2 ml solvent

Two sterile syringes, one with needle for reconstitution

Three hypodermic safety needles

One vial adapter

Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection.

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

Shelf-life after reconstitution: 4 hours below 25 °C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/003

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 THE OUTER PACKAGING

Outer label (with blue box) - Multipack 400 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 400 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: Three single packages, each containing:

One vial of powder

One vial of 2 ml solvent

Two sterile syringes, one with needle for reconstitution

Three hypodermic safety needles

One vial adapter

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection.

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

Shelf-life after reconstitution: 4 hours below 25 °C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/004

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 THE OUTER PACKAGING

Carton (without blue box) – component of multipack 400 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 400 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Single package containing:

One vial of powder

One vial of 2 ml solvent

Two sterile syringes, one with needle for reconstitution

Three hypodermic safety needles

One vial adapter

Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection.

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

Shelf-life after reconstitution: 4 hours below 25 °C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/004

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

Vial Powder 300 mg

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

Abilify Maintena 300 mg powder for prolonged-release injection aripiprazole

IM

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

300 mg

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial Powder 400 mg

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

Abilify Maintena 400 mg powder for prolonged-release injection aripiprazole

IM

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

400 mg

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial Solvent

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

Solvent for Abilify Maintena

Water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton - Single pack 300 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 300 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. Three hypodermic safety needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white and use immediately. If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.

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

Shelf-life after reconstitution: 2 hours below 25 °C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

Keep the pre-filled 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

Discard pre-filled syringe and needles appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/005

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 THE OUTER PACKAGING

Outer carton - Single pack 400 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 400 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. Three hypodermic safety needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white and use immediately. If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.

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

Shelf-life after reconstitution: 2 hours below 25 °C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

Keep the pre-filled 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

Discard pre-filled syringe and needles appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/006

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 THE OUTER PACKAGING

Outer label (with blue box) - Multipack 300 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 300 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: Three single packages, each containing:

One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. Three hypodermic safety needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white and use immediately. If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.

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

Shelf-life after reconstitution: 2 hours below 25°C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

Keep the pre-filled 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

Discard pre-filled syringe and needles appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/007

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 THE OUTER PACKAGING

Carton (without blue box) – component of multipack 300 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 300 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Single package containing:

One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. Three hypodermic safety needles

Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white and use immediately. If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.

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

Shelf-life after reconstitution: 2 hours below 25 °C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

Keep the pre-filled 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

Discard pre-filled syringe and needles appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/007

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 THE OUTER PACKAGING

Outer label (with blue box) - Multipack 400 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 400 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: Three single packages, each containing:

One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. Three hypodermic safety needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white and use immediately. If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.

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

Shelf-life after reconstitution: 2 hours below 25°C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

Keep the pre-filled 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

Discard pre-filled syringe and needles appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/008

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 THE OUTER PACKAGING

Carton (without blue box) – component of multipack 400 mg

1. NAME OF THE MEDICINAL PRODUCT

Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 400 mg aripiprazole.

After reconstitution each ml of suspension contains 200 mg aripiprazole.

3. LIST OF EXCIPIENTS

Powder

Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide

Solvent

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Single package containing:

One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. Three hypodermic safety needles

Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use only

Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white and use immediately. If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.

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

Shelf-life after reconstitution: 2 hours below 25°C

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

Keep the pre-filled 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

Discard pre-filled syringe and needles appropriately.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/882/008

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

Pre-filled syringe - 300 mg

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

Abilify Maintena 300 mg injection aripiprazole

IM

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

300 mg

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Pre-filled syringe - 400 mg

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

Abilify Maintena 400 mg injection aripiprazole

IM

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

400 mg

6. OTHER

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