TISSEEL Ready to use Solution for Sealant (10ml vial)

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

HUMAN FIBRINOGEN; APROTININ; HUMAN THROMBIN; CALCIUM CHLORIDE DIHYDRATE

から入手可能:

Baxter Healthcare Limited

ATCコード:

B02BC

INN（国際名）:

HUMAN FIBRINOGEN; APROTININ; HUMAN THROMBIN; CALCIUM CHLORIDE DIHYDRATE

医薬品形態:

SOLUTION FOR SEALANT

構図:

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

処方タイプ:

POM

治療領域:

ANTIHEMORRHAGICS

認証ステータス:

Authorised

情報リーフレット

Fibrin Sealant VH S/D 500 IU Frozen
AT/H/0317/001/II/044/G
1/29
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.
Fibrin Sealant VH S/D 500 IU Frozen
AT/H/0317/001/II/044/

製品の特徴

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.
3. PHARMACEUTICAL FORM
Solutions for sealant
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.
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 point 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]).
The efficacy in fully heparinized patients has been proven.
4.2
POSOLOGY AND METHOD OF ADMINIS