TISSEEL FROZEN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

APROTININ ACETATE; CALCIUM CHLORIDE DIHYDRATE; HUMAN FIBRINOGEN; HUMAN THROMBIN

Available from:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATC code:

B02BC30

Pharmaceutical form:

SOLUTIONS FOR SEALANT

Composition:

CALCIUM CHLORIDE DIHYDRATE 40 MCMOL/ML; HUMAN THROMBIN 500 IU / 1 ML; APROTININ ACETATE 3000 KIU / 1 ML; HUMAN FIBRINOGEN 91 MG / 1 ML

Administration route:

EPILESIONAL

Prescription type:

Required

Manufactured by:

TAKEDA MANUFACTURING AUSTRIA AG, AUSTRIA

Therapeutic area:

COMBINATIONS

Therapeutic indications:

Supportive treatment in adults and children from 1 month of age where standard surgical techniques appear insufficient: * For improvement of Hemostasis.* As a tissue glue to improve wound healing or to support sutures in vascular surgery and in gastrointestinal anastomoses.* For tissue sealing, to improve adhesion of the separated tissue (e.g. tissue flaps, grafts, split skin grafts [mesh grafts]).Efficacy in fully heparinized patients has been proven.

Authorization date:

2019-10-06

Summary of Product characteristics

TISSEEL FROZEN
Solutions for sealant
PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
TISSEEL FROZEN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPONENT 1: SEALER PROTEIN SOLUTION
Human fibrinogen (as clottable protein)
91 mg
1
/ml
Aprotininacetate
3000 KIU
2
/ml
Excipient(s) with known effect:
Polysorbate 80
1.25 mg/ml
COMPONENT 2: THROMBIN SOLUTION
Human thrombin
500 IU
3
/ml
Calcium chloride dihydrate
40

mol/ml
1, 2 or 5 ml sealer protein solution (with synthetic aprotinin) and 1,
2 or 5 ml thrombin
solution (with calcium chloride dihydrate) combine to make 2, 4 or 10
ml ready-to-use fibrin
sealant solution.
After mixing
1 ml
2 ml
4 ml
10 ml
COMPONENT 1: SEALER
PROTEIN SOLUTION
Human fibrinogen (as
clottable protein)
Synthetic Aprotinin
45.5 mg
1500 KIU
91mg
3000 KIU
182 mg
6000 KIU
455 mg
15000 KIU
COMPONENT 2:
THROMBIN SOLUTION
Human thrombin
Calcium chloride
dihydrate
250 IU
20 μmol
500 IU
40 μmol
1000 IU
80 μmol
2500 IU
200 μmol
TISSEEL FROZEN contains Human Factor XIII co-purified with Human
Fibrinogen in a range
of 0.6 - 5 IU/ml.
1
Contained in a total protein concentration of 96 – 125 mg/ml
2
1 EPU (European Pharmacopoeia Unit) corresponds to 1800 KIU
(Kallidinogenase Inactivator Unit)
3
Thrombin activity was determined using the current WHO Standard for
thrombin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solutions for sealant
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supportive treatment in adults and children from 1 month of age where
standard surgical
techniques appear insufficient

For improvement of hemostasis.

As a tissue glue to improve wound healing or to support sutures in
vascular surgery and
in gastrointestinal anastomoses.

For tissue sealing, to improve adhesion of the separated tissue (e.g.
tissue flaps, grafts,
split skin grafts [mesh grafts]).
The efficacy in fully heparinized patients has been proven.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of TISSEEL FROZEN is restricted to experienced surgeons who
have be