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Evicel (human fibrinogen / human thrombin) – Labelling - B02BC

Updated on site: 06-Oct-2017

Medication nameEvicel
ATC CodeB02BC
Substancehuman fibrinogen / human thrombin
ManufacturerOmrix Biopharmaceuticals N. V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton box containing 2 vials

1.NAME OF THE MEDICINAL PRODUCT

EVICEL solutions for sealant

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Solutions for sealant

The active substances are as follows:

Component 1: 1 vial containing 1 ml of human clottable protein (50 – 90 mg/ml)

Component 2: 1 vial containing 1 ml of human thrombin (800 – 1200 IU/ml).

The active substances are as follows:

Component 1: 1 vial containing 2 ml of human clottable protein (50 – 90 mg/ml)

Component 2: 1 vial containing 2 ml of human thrombin (800 – 1200 IU/ml).

The active substances are as follows:

Component 1: 1 vial containing 5 ml of human clottable protein (50 – 90 mg/ml)

Component 2: 1 vial containing 5 ml of human thrombin (800 – 1200 IU/ml).

3.LIST OF EXCIPIENTS

Human Fibrinogen: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, water for injections.

Human Thrombin: calcium chloride, human albumin, mannitol, sodium acetate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solutions for sealant

The active substances are as follows:

Component 1: 1 vial containing 1 ml of human clottable protein (50 – 90 mg/ml)

Component 2: 1 vial containing 1 ml of human thrombin (800 – 1200 IU/ml).

The active substances are as follows:

Component 1: 1 vial containing 2 ml human clottable protein (50 – 90 mg/ml)

Component 2: 1 vial containing 2 ml of human thrombin (800 – 1200 IU/ml).

The active substances are as follows:

Component 1: 1 vial containing 5 ml of human clottable protein (50 – 90 mg/ml)

Component 2: 1 vial containing 5 ml of human thrombin (800 – 1200 IU/ml).

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For epilesional 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

Do not apply intravascularly

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Keep upright.

Do not re-freeze once thawed.

Store in the outer carton at -18°C or colder, to protect from light. After thawing, store unopened vials in the outer carton at 2-8°C for up to 30 days starting on:

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

Any unused product should be discarded in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Omrix Biopharmaceuticals N.V.

Leonardo Da Vinci Laan 15

B-1831 Diegem

Belgium

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/473/001

EU/1/08/473/002

EU/1/08/473/003

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.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial label

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

Human fibrinogen:

EVICEL solutions for sealant

Component 1: Human clottable protein 50 – 90 mg/ml

2.METHOD OF ADMINISTRATION

For epilesional use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1ml

2ml

5ml

6.OTHER

To be used as two-component product with supplied device.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial label

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

Human thrombin:

EVICEL solutions for sealant

Component 2: Human thrombin 800-1200 IU/ml

2. METHOD OF ADMINISTRATION

For epilesional use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1ml

2ml

5ml

6. OTHER

To be used as two-component product with supplied device.

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