ARTISS Solutions for Sealant, deep frozen

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Human fibrinogen; Human thrombin; Calcium chloride; Aprotinin

Tillgänglig från:

Baxter Holding B.V.

ATC-kod:

B02BC; V03AK

INN (International namn):

Human fibrinogen; Human thrombin; Calcium chloride; Aprotinin

Dos:

4 ml

Läkemedelsform:

Solution for sealant

Terapiområde:

Local hemostatics; Tissue adhesives

Bemyndigande status:

Marketed

Tillstånd datum:

2009-07-03

Bipacksedel

b
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARTISS Solutions for Sealant
Deep frozen
Human Fibrinogen, Human Thrombin, 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 or pharmacist.
This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What ARTISS is and what it is used for
2.
What you need to know before you use ARTISS
3.
How to use ARTISS
4.
Possible side effects
5.
How to store ARTISS
6.
Contents of the pack and other information
1.
What ARTISS is and what it is used for
What ARTISS is
ARTISS 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.
ARTISS is prepared as two solutions (Sealer Protein Solution and
Thrombin
Solution), which mix when applied.
What ARTISS is used for
ARTISS is a tissue sealant.
ARTISS is applied to glue soft tissues in plastic, reconstructive and
burn surgery.
For example, ARTISS may be used to glue skin grafts or skin flaps to
burn wounds
or to glue skin to the underlying tissue in plastic surgery. Also,
artificial skin may
be glued to wounds with ARTISS.
The
clot
produced
by
ARTISS
is
very
similar
to
a
natural
blood
clot.
This
means that it will dissolve naturally and leave no residue. However,
aprotinin
(a
protein, that delays dissolution of a clot) is added to increase the
longevity of
the clot and to prevent its premature dissolution.
2. What you need to know before you use ARTISS
Do not use ARTISS:
•
if you are allergic to any of the active substances or any of the
other ingredients
of this medicine (listed in section 6).
•
ARTISS must not be used for mas

Produktens egenskaper

Health Products Regulatory Authority
02 July 2021
CRN009Q7G
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ARTISS Solutions for Sealant, deep frozen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1:
Sealer Protein Solution
Human Fibrinogen 91 mg[1]/ml (as clottable protein) produced from the
plasma of human donors
Aprotinin (synthetic) 3000 KIU[2]/ml
Component 2:
Thrombin Solution
Human Thrombin 4 IU[3]/ml produced from the plasma of human donors
Calcium Chloride Dihydrate 40 μmol/ml
1 prefilled double chamber syringe which contains Sealer Protein
Solution (with Aprotinin), deep frozen <1 ml><2 ml><5 ml>,
in one chamber and Thrombin Solution (with Calcium Chloride
Dihydrate), deep frozen<1 ml><2 ml><5 ml>, in the other
chamber results in <2 ml><4 ml><10 ml> total volume of 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 (synthetic)
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 Dihydrate
2 IU
20 μmol
4 IU
40 μmol
8 IU
80 μmol
20 IU
200 μmol
ARTISS 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 is calculated using the current WHO
International Standard for Thrombin.
3 PHARMACEUTICAL FORM
Solutions for Sealant
Deep frozen
Colourless to pale yellow and clear to slightly turbid solutions.
Component 1, Sealer Protein Solution: pH 6.5 – 8.0
Component 2, Thrombin Solution: pH 6.0 – 8.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARTISS is indicated as a tissue glue to adhere/seal subcutaneous
tissue in plastic, reconstructive and burn surgery, as a
replacement or an adjunct to sutures or staples (see 5.1). In
add