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Zarzio (filgrastim) – Labelling - L03AA02

Updated on site: 11-Oct-2017

Medication nameZarzio
ATC CodeL03AA02
Substancefilgrastim
ManufacturerSandoz GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – PRE-FILLED SYRINGE

1.NAME OF THE MEDICINAL PRODUCT

Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe

Filgrastim

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 30 million units (equivalent to 300 micrograms) filgrastim in 0.5 ml (60 MU/ml).

3.LIST OF EXCIPIENTS

Excipients: glutamic acid, polysorbate 80, water for injections and sorbitol (E420). See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection or infusion in pre-filled syringe.

1 pre-filled syringe without needle safety guard

3 pre-filled syringes without needle safety guard

5 pre-filled syringes without needle safety guard

10 pre-filled syringes without needle safety guard

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Single use only. Read the package leaflet before use.

Subcutaneous or intravenous 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

After dilution use within 24 hours.

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/495/009

EU/1/08/495/010

EU/1/08/495/011

EU/1/08/495/012

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zarzio 30 MU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe

Filgrastim

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 48 million units (equivalent to 480 micrograms) filgrastim in 0.5 ml (96 MU/ml).

3. LIST OF EXCIPIENTS

Excipients: glutamic acid, polysorbate 80, water for injections and sorbitol (E420). See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection or infusion in pre-filled syringe.

1 pre-filled syringe without needle safety guard

3 pre-filled syringes without needle safety guard

5 pre-filled syringes without needle safety guard

10 pre-filled syringes without needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Single use only. Read the package leaflet before use.

Subcutaneous or intravenous 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

After dilution use within 24 hours.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/495/013

EU/1/08/495/014

EU/1/08/495/015

EU/1/08/495/016

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zarzio 48 MU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – PRE-FILLED SYRINGE WITH A NEEDLE SAFETY GUARD

1. NAME OF THE MEDICINAL PRODUCT

Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe

Filgrastim

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 30 million units (equivalent to 300 micrograms) filgrastim in 0.5 ml (60 MU/ml).

3. LIST OF EXCIPIENTS

Excipients: glutamic acid, polysorbate 80, water for injections and sorbitol (E420). See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection or infusion in pre-filled syringe.

1 pre-filled syringe with a needle safety guard 3 pre-filled syringes with a needle safety guard 5 pre-filled syringes with a needle safety guard 10 pre-filled syringes with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Single use only. Read the package leaflet before use.

Subcutaneous or intravenous 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

After dilution use within 24 hours.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/495/001

EU/1/08/495/002

EU/1/08/495/003

EU/1/08/495/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zarzio 30 MU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – PRE-FILLED SYRINGE WITH A NEEDLE SAFETY GUARD

1. NAME OF THE MEDICINAL PRODUCT

Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe

Filgrastim

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 48 million units (equivalent to 480 micrograms) filgrastim in 0.5 ml (96 MU/ml).

3. LIST OF EXCIPIENTS

Excipients: glutamic acid, polysorbate 80, water for injections and sorbitol (E420). See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection or infusion in pre-filled syringe.

1 pre-filled syringe with a needle safety guard 3 pre-filled syringes with a needle safety guard 5 pre-filled syringes with a needle safety guard 10 pre-filled syringes with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Single use only. Read the package leaflet before use.

Subcutaneous or intravenous 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

After dilution use within 24 hours.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/495/005

EU/1/08/495/006

EU/1/08/495/007

EU/1/08/495/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zarzio 48 MU/0.5 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE / PRE-FILLED SYRINGE WITH A NEEDLE SAFETY GUARD

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

Zarzio 30 MU/0.5 ml injection or 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

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE / PRE-FILLED SYRINGE WITH A NEEDLE SAFETY GUARD

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

Zarzio 48 MU/0.5 ml injection or 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

6. OTHER

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