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Savene (dexrazoxane hydrochloride) – Labelling - V03AF02

Updated on site: 10-Oct-2017

Medication nameSavene
ATC CodeV03AF02
Substancedexrazoxane hydrochloride
ManufacturerClinigen Healthcare Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

KIT BOX (1 KIT CONSISTING OF 10 POWDER VIALS AND 3 DILUENT BOTTLES)

1.NAME OF THE MEDICINAL PRODUCT

Savene 20 mg/ml powder for concentrate and diluent for solution for infusion (dexrazoxane)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).

After reconstitution with 25 ml Savene diluent, 1 ml of concentrate contains 20 mg dexrazoxane

3.LIST OF EXCIPIENTS

Excipients Savene powder: none

Excipients Savene diluent:

Sodium chloride Potassium chloride

Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate

Sodium hydroxide Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate and diluent for solution for infusion 10 vials of 500 mg dexrazoxane

3 bottles of 500 ml diluent

Emergency kit for the treatment of anthracycline extravasation

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use after reconstitution and dilution

Read the package leaflet before 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

To be administered under the supervision of a physician experienced in the use of cytotoxic agents

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store below 25 °C

Concentrate and diluted solution may be stored at 2 to 8 °C for 4 hours

Keep vials and bottles 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

Contains cytotoxics.

Any unused product or waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Clinigen Healthcare Ltd

Pitcairn House

Crown Square, First Avenue

Burton-on-Trent, Staffordshire

DE14 2WW

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/350/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS FOR USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

POWDER VIAL

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

Savene 20 mg/ml powder for concentrate dexrazoxane

Intravenous use after reconstitution and dilution

2.METHOD OF ADMINISTRATION

Read the package leaflet before use

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 mg dexrazoxane

6.OTHER

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

DILUENT BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Savene diluent

2. STATEMENT OF ACTIVE SUBSTANCE(S)

3. LIST OF EXCIPIENTS

Sodium chloride

Potassium chloride

Magnesium chloride hexahydrate

Sodium acetate trihydrate

Sodium gluconate

Sodium hydroxide

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

500 ml diluent

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use after dilution with concentrate

Read the package leaflet before 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

Contains cytotoxics after dilution with concentrate

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store below 25°C.

Keep in the outer carton in order to protect from light

To be used within 4 hours after dilution when stored at 2-8°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused product or waste material should be disposed of in accordance with local requirements

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Clinigen Healthcare Ltd

Pitcairn House

Crown Square, First Avenue

Burton-on-Trent, Staffordshire

DE14 2WW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/350/001

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

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