ARTISS Solutions for Sealant, deep frozen

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human fibrinogen; Human thrombin; Calcium chloride; Aprotinin

Available from:

Baxter Healthcare Limited

ATC code:

B02BC; V03AK

INN (International Name):

Human fibrinogen; Human thrombin; Calcium chloride; Aprotinin

Dosage:

4 ml

Pharmaceutical form:

Solution for sealant

Prescription type:

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

Therapeutic area:

Local hemostatics; Tissue adhesives

Authorization status:

Marketed

Authorization date:

2009-07-03

Patient Information leaflet

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 mass

Summary of Product characteristics

Health Products Regulatory Authority
30 January 2019
CRN008SF0
Page 1 of 16
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 (as clottable protein) 91 mg
1
/ml
Aprotinin (synthetic) 3000 KIU
2
/ml
Component 2:
Thrombin Solution
Human Thrombin 4 IU
3
/ml
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)
45.5 mg
91 mg
182 mg
455 mg
Aprotinin (synthetic)
1,500 KIU
3,000 KIU
6,000 KIU
15,000 KIU
Component 2: Thrombin Solution
Human Thrombin
2 IU
4 IU
8 IU
20 IU
Calcium Chloride Dihydrate
20 mmol
40 mmol
80 mmol
200 mmol
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
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.
Health Products Regulatory Authority
30 January 2019
CRN008SF0
Page 2 of 16
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 addition, ARTISS is