TISSEEL – Solutions for sealant (10ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HUMAN FIBRINOGEN, APROTININ, HUMAN THROMBIN, CALCIUM CHLORIDE, DIHYDRATE

Available from:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC code:

B02BC30

INN (International Name):

HUMAN FIBRINOGEN 455 mg APROTININ 1500 KIU/ml HUMAN THROMBIN 2500 IU CALCIUM CHLORIDE DIHYDRATE 200 mmol

Pharmaceutical form:

SOLUTION FOR SEALANT

Composition:

HUMAN FIBRINOGEN 455 mg APROTININ 1500 KIU/ml HUMAN THROMBIN 2500 IU CALCIUM CHLORIDE DIHYDRATE 200 mmol

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Authorization status:

Authorised

Authorization date:

2014-07-29

Patient Information leaflet

Page
1
of
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
TISSEEL - SOLUTIONS FOR SEALANT
Human fibrinogen, human thrombin, synthetic aprotinin, calcium
chloride dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor or pharmacist.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TISSEEL is and what it is used for
2.
What you need to know before you use TISSEEL
3.
How to use TISSEEL
4.
Possible side effects
5.
How to store TISSEEL
6.
Contents of the pack and other information
1.
WHAT TISSEEL IS AND WHAT IT IS USED FOR
WHAT TISSEEL IS
TISSEEL is a two-component tissue sealant, consisting of two
solutions, the sealer protein
solution and the thrombin solution. Tisseel contains fibrinogen and
thrombin. These are two
blood proteins which are important for blood coagulation. When these
proteins are mixed
during application, they form a clot at the application site.
The clot formed by TISSEEL is very similar to the clot formed in
normal blood coagulation. It is
degraded in the same way as an endogenous (body’s own) clot and does
not leave any residue. A
synthetic protein (synthetic aprotinin) is added, to extend the life
of the clot and to prevent
premature degradation.
WHAT TISSEEL IS USED FOR
TISSEEL is used as a supportive treatment when conventional surgical
methods appear to be insufficient:
-
to improve hemostasis
-
as tissue glue, to improve wound healing or to seal sutures in
vascular surgery and in the
gastrointestinal tract.
-
for tissue gluing, e.g. for attaching skin grafts.
TISSEEL is also effective in patients who are treated with the
coagulation-inhibiting preparation heparin.
Page
2
of
24
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TISSEEL
DO NOT USE TISSEEL:
-
if you are allergic ( hyp

Summary of Product characteristics

Page
1
of
19
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
TISSEEL – Solutions for sealant
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPONENT 1: SEALER PROTEIN SOLUTION
Human fibrinogen (as clottable protein)
91 mg
1
/ml
Aprotinin (synthetic)
3000 KIU
2
/ml
Excipient(s) with known effect:
Polysorbate 80
0.6 – 1.9 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
contains
Human
Factor
XIII
co-purified
with
Human
Fibrinogen
in
a
range
of
0.6 - 5 IU/ml.
For the full list of excipients, see section 6.1.
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.
Page
2
of
19
3. PHARMACEUTICAL FORM
Solutions for sealant
The frozen solutions are colorless to pale yellow, opalescent;
After thawing, they are colorless to pale yellow.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supportive treatment where standard surgical techniques appear
insufficient (see section 5.1)
•
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], fixation of subcutaneously implanted lightweight
mesh).
The efficac