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Rapilysin (reteplase) – Labelling - B01AD08

Updated on site: 09-Oct-2017

Medication nameRapilysin
ATC CodeB01AD08
Substancereteplase
ManufacturerActavis Group PTC ehf

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Rapilysin 10 U powder and solvent for solution for injection

Water for injections for Rapilysin 10 U solution for intravenous use

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Reteplase 10 U (recombinant plasminogen activator, thrombolytic agent)

3.LIST OF EXCIPIENTS

Powder: Tranexamic acid

di potassium-hydrogen phosphate phosphoric acid

sucrose Polysorbate 80

Solvent:

Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for injection (contains 2x [0.56 g of powder in a vial and 10 ml solvent in a prefilled syringe with reconstitution spike and needle])

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use

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

Use the solution immediately after reconstitution

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 °C

Keep the vial 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

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjordur Iceland.

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/96/018/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL OF THE VIAL

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

Rapilysin 10 U powder and solvent for solution for injection

Reteplase Intravenous use

2.METHOD OF ADMINISTRATION

Use the solution immediately after reconstitution

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 U reteplase

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL OF THE SYRINGE

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

Water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

6. OTHER

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