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TachoSil (human fibrinogen / human thrombin) – Labelling - B02BC30

Updated on site: 10-Oct-2017

Medication nameTachoSil
ATC CodeB02BC30
Substancehuman fibrinogen / human thrombin
ManufacturerTakeda Austria GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

TachoSil, sealant matrix

Human fibrinogen/Human thrombin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each matrix contains per cm2

Human fibrinogen 5.5 mg

Human thrombin 2.0 IU

3.LIST OF EXCIPIENTS

Equine collagen, human albumin, riboflavine (E101), sodium chloride, sodium citrate (E331), L-arginine-hydrochloride

4.PHARMACEUTICAL FORM AND CONTENTS

Sealant matrix

1 matrix of 9.5 cm x 4.8 cm

2 matrices of 4.8 cm x 4.8 cm

1 matrix of 3.0 cm x 2.5 cm

5 matrices of 3.0 cm x 2.5 cm

1 pre-rolled matrix of 4.8 cm x 4.8 cm

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

Once the foil sachet is opened, use immediately. Do not resterilise.

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 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

Takeda Austria GmbH

St.Peter Strasse 25

A- 4020 Linz, Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/277/001 1 matrix of 9.5 cm x 4.8 cm

EU/1/04/277/002 2 matrices of 4.8 cm x 4.8 cm

EU/1/04/277/003 1 matrix of 3.0 cm x 2.5 cm

EU/1/04/277/004 5 matrices of 3.0 cm x 2.5 cm

EU/1/04/277/005 1 pre-rolled matrix of 4.8 cm x 4.8 cm

13.BATCH NUMBER

Batch

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

ALUMINIUM-BONDED FOIL SACHET

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

TachoSil, sealant matrix

Human fibrinogen/Human thrombin

For epilesional use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use

3.EXPIRY DATE

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 matrix of 9.5 cm x 4.8 cm

1 matrix of 4.8 cm x 4.8 cm

1 matrix of 3.0 cm x 2.5 cm

1 pre-rolled matrix of 4.8 cm x 4.8 cm

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POLYETHYLENE TEREPHTHALATE BLISTER

1. NAME OF THE MEDICINAL PRODUCT

TachoSil

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Takeda

3. EXPIRY DATE

4. BATCH NUMBER

Batch

5.OTHER

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