TISSEEL KIT

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FACTOR I (FIBRINOGEN) PLASMAFIBRONECTIN FACTOR XIII PROFIBRINOLYSIN APROTININ THROMBIN PROTEIN THROMBIN PROTEIN CALCIUM CHLORIDE DIHYDRATE

Available from:

Baxter Healthcare Limited

Dosage:

0.5ml Millilitre

Pharmaceutical form:

Cutaneous Solution

Authorization date:

2007-03-09

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tisseel Kit 0.5 ml
Two-Component Fibrin Sealant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1.
COMPOSITION OF TISSEEL, SEALER PROTEIN CONCENTRATE, LYOPHILISED
1 vial of TISSEEL of TISSEEL
®
KIT 1.0 ml, to be reconstituted with 1.0 ml of Aprotinin Solution 3000 KlU/ml.
contains:
2.2
COMPOSITION OF APROTININ SOLUTION
2.3
COMPOSITION OF HUMAN THROMBIN, LYOPHILISED
1 vial contains 2, 4, 8 or 20 IU and 250, 500, 1000 or 2500 IU, respectively.
1 vial of Thrombin of TISSEEL
®
KIT 1.0, to be reconstituted with 1.0 ml of Calcium Chloride Solution, contains:
Active Ingredients:
Total Protein
100.00 – 130.00
mg
Clottable Protein
75.00 - 115.00
mg
thereof: Fibrinogen
70.00 - 110.00
mg
Plasmafibronectin (CIG)
2.00 -
9.00
mg
Factor XIII
10.00 -
50.00
U**
Plasminogen
0.04 -
0.12
mg
Excipients:
Human Albumin
10.00 - 20.00
mg
Glycine
15.00 - 35.00
mg
Sodium Chloride
2.00 –
4.00
mg
Sodium Citrate
4.00 -
8.00
mg
Triton WR 1339
0.20 -
0.40
mg
The vials of TISSEEL
®
KIT 0.5, 2.0, and 5.0 contain half, twice, and 5 times
respectively the quantities indicated above.
** 1 unit of Factor XIII corresponds to the activity of this factor in 1 ml of fresh
normal plasma.
Active Ingredients:
1 ml of the solution contains:
Aprotinin (bovine)
3000.00 KIU*
Excipients:
Water for Injections B.P. ad
1.00 ml
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/04/2010_
_CRN 2081368_
_page number: 1_
The vials of TISSEEL
®
KIT 0.5, 2.0, and 5.0 contain half, twice, and 5 times respectively the quantities indicated
above.
* 880 Kallidogenase Inactivator Units (KIU) correspond to I European Pharmacopoeia Unit
(EPU)
** 1 International Unit (1.U.) of Human Thrombin is defined