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Parsabiv (etelcalcetide hydrochloride) – Labelling - H05BX04

Updated on site: 09-Oct-2017

Medication nameParsabiv
ATC CodeH05BX04
Substanceetelcalcetide hydrochloride
ManufacturerAmgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Parsabiv 2.5 mg solution for injection etelcalcetide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 2.5 mg of etelcalcetide (as hydrochloride).

3.LIST OF EXCIPIENTS

Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. 1 vial (0.5 mL)

6 vials (0.5 mL)

12 vials (0.5 mL)

42 vials (0.5 mL)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use.

Single use only

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.

Keep in the original 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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1142/001

EU/1/16/1142/002

EU/1/16/1142/003

EU/1/16/1142/004

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC

SN

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

Parsabiv 2.5 mg solution for injection etelcalcetide

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

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Parsabiv 5 mg solution for injection etelcalcetide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 5 mg of etelcalcetide (as hydrochloride).

3. LIST OF EXCIPIENTS

Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. 1 vial (1 mL)

6 vials (1 mL)

12 vials (1 mL)

42 vials (1 mL)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use.

Single use only

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.

Keep in the original 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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1142/005

EU/1/16/1142/006

EU/1/16/1142/007

EU/1/16/1142/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC

SN

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

Parsabiv 5 mg solution for injection etelcalcetide

IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 mL

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Parsabiv 10 mg solution for injection etelcalcetide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 10 mg of etelcalcetide (as hydrochloride).

3. LIST OF EXCIPIENTS

Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. 1 vial (2 mL)

6 vials (2 mL)

12 vials (2 mL)

42 vials (2 mL)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use.

Single use only

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.

Keep in the original 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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1142/009

EU/1/16/1142/010

EU/1/16/1142/011

EU/1/16/1142/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC

SN

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

Parsabiv 10 mg solution for injection etelcalcetide

IV

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

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