TISSEEL Lyo Powder and Solvent for Sealant

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Human fibrinogen; Human factor xiii; Aprotinin; Human thrombin; Calcium chloride

Dostupno od:

Baxter Holding B.V.

ATC koda:

B02BC; V03AK

INN (International ime):

Human fibrinogen; Human factor xiii; Aprotinin; Human thrombin; Calcium chloride

Doziranje:

.

Farmaceutski oblik:

Powder and solvent for sealant

Područje terapije:

Local hemostatics; Tissue adhesives

Status autorizacije:

Marketed

Datum autorizacije:

2011-01-21

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
TISSEEL LYO
Powder and Solvent for Sealant
ACTIVE SUBSTANCES:
Human fibrinogen, human thrombin, aprotinin, calcium chloride
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects become serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist. See section 4
IN THIS LEAFLET:
1.
What TISSEEL Lyo is and what it is used for
2.
Before
you use TISSEEL Lyo
3.
How to use TISSEEL Lyo
4.
Possible side effects
5.
How to store TISSEEL Lyo
6.
Further information
1.
WHAT TISSEEL LYO IS AND WHAT IT IS USED FOR
WHAT TISSEEL LYO IS
The name of your medicine is TISSEEL Lyo.
TISSEEL Lyo is a two-component fibrin sealant, and it contains two of
the proteins that
make blood clot. These proteins are called fibrinogen and thrombin.
When these proteins
mix during application, they form a clot where the surgeon applies
them.
TISSEEL Lyo is prepared as two solutions (Sealer Protein Solution and
Thrombin
Solution), which mix when applied.
WHAT TISSEEL LYO IS USED FOR
TISSEEL Lyo is a fibrin or tissue sealant. During surgery, tissues may
bleed and it may not be
possible for the surgeon to control this bleeding using stitches, or
by applying pressure. TISSEEL
Lyo is applied to the surface of tissues either to control bleeding,
or to stop (or prevent) leaks of
other types of fluid by creating a watertight seal.
Reconstituted TISSEEL Lyo is used as a tissue sealant and haemostatic
for surgical incisions,
plastic surgical repairs, orthopaedic traumatic and dental surgery.
TISSEEL can also be applied to tension-free detached tissues to glue
them together. TISSEEL
Lyo can be used even if your blood does not clot properly, e.g. when
you are treated with heparin
against thrombosis.
The clot produced by TISSEEL Lyo is very similar to a natural blood
clot and this means that it
wil

Svojstava lijeka

HealthProductsRegulatoryAuthority
22March2019
CRN008KFY
Page1of16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TISSEELLyoPowderandSolventforSealant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1:
SealerProteinSolution
(SealerProteinConcentrate-Lyophilized-reconstituted
withAprotininSolution)
HumanFibrinogen(asclottableProtein)
91mg
1
/ml
HumanFactorXIII
0.6-5 IU/ml
Aprotinin
3000KIU
2
/ml
Component2:
ThrombinSolution
(Thrombin-Lyophilized-reconstitutedwithCalcium
ChlorideSolution)
HumanThrombin
500IU
3
/ml
CalciumChloride
40micromoles/ml
1ml,2ml
and5mlSealerProteinSolutionand1ml,2ml
and5mlThrombinSolution,respectively,resultin2ml,
4mland10
mlfinalproductreadyforuse.
Aftermixing
1ml
2ml
4ml
10ml
Component1:Sealerproteinsolution
HumanFibrinogen
(asclottableprotein)
Aprotinin
45.5mg
1,500KIU
91mg
3,000KIU
182mg
6,000KIU
455mg
15,000KIU
Component2:Thrombinsolution
HumanThrombin
CalciumChloride
250IU
20
micromoles
500IU
40
micromoles
1,000IU
80
micromoles
2,500IU
200
micromoles
Forfulllistofexcipients,seesection6.1. 
1
Containedinatotalproteinconcentrationof
110.5mg/ml
2
1EPU(EuropeanPharmacopoeiaUnit)correspondsto1800KIU(KallidinogenaseInactivatorUnit)
3
ThrombinactivityiscalculatedusingthecurrentWHOInternationalStandardforThrombin.
3 PHARMACEUTICAL FORM
PowderandSolventforSealant
Freeze-driedconstituentsarehygroscopic,whiteorpaleyellowpowdersorfriablesolids;liquid
constituentsareclear,colourlesssolutions.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Asacoagulantproducerforus