TISSEEL Ready to use Solutions for Sealant

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

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

제공처:

Baxter Healthcare Limited

ATC 코드:

B02BC; V03AK

INN (국제 이름):

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

복용량:

.

약제 형태:

Solution for sealant

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Local hemostatics; Tissue adhesives

승인 상태:

Marketed

승인 날짜:

2010-11-19

환자 정보 전단

b
0743883
PACKAGE LEAFLET: INFORMATION FOR THE USER
TISSEEL
Ready to use
Solutions 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 you get any side effects, talk to your doctor or pharmacist.
This includes
any possible side effects not listed in this leaflet. See section 4.
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
The name of your medicine is TISSEEL.
TISSEEL is a two-component tissue 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 is prepared as two solutions (Sealer Protein Solution and
Thrombin
Solution), which mix when applied.
What TISSEEL is used for
TISSEEL 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 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.
TISSEEL can also be applied to tension-free detached tissues to glue
them
together. TISSEEL can be used even if your blood does not clot
properly, e.g.
when you are being treated with heparin against thrombosis.
The clot produced by TISSEEL is very similar to a natural blood clot
and this
means that it will dissolve naturally and leave no residue. However,
aprotinin is
added to increase the longevity of the clot and to prevent its
premature dissolution.
2. WHAT YOU NEE

제품 특성 요약

Health Products Regulatory Authority
02 February 2019
CRN008LGD
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TISSEEL Ready to use Solutions for Sealant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1:
Sealer Protein 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
Human Thrombin 500 IU
3
/ml
Calcium Chloride 40 micromoles/ml
For a full list of excipients, see section 6.1.
1 prefilled double chamber syringe which contains Sealer Protein
Solution (with
Aprotinin), deep frozen 1 ml, 2 ml, or 5 ml, in one chamber and
Thrombin Solution
(with Calcium Chloride), deep frozen 1 ml, 2 ml, or 5 ml, in the other
chamber results
in 2 ml, 4 ml, or 10 ml total volume of product ready for use.
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
Solutions for Sealant
Colourless to pale yellow and clear to slightly turbid solutions.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a coagulant producer for use as a tissue sealant and haemostatic,
for surgical
incisions, plastic surgical repairs, orthopaedic, traumatic, and
dental surgery.
Health Products Regulatory Authority
02 February 2019
CRN008LGD
Page 2 of 18
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TISSEEL is for topical (i.e., epilesional) use only, do not inject
TISSEEL must not be applied intravascularly (see Section 4.3)
The use of TISSEEL is restricted to experienced surgeons who have been
trained in
the use of TISSEEL.
Posology:
The amount of TISSEEL to be applied and the frequency of application
should always
be oriented towards the underlying clinical needs of the patient.
The dose to be applied is governed by variables including, but not
limited to, the
type of surgical intervention, the size of the area a