ARTISS

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Thrombin; Factor XIII; Calcium chloride; Fibrinogen; Aprotinin

Available from:

Baxter Healthcare Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ARTISS ((frozen) fibrin sealant syringe) 

Consumer Medicine Information 

ARTISS CMI 130624 

Page 1 of 4 
Baxter 

ARTISS 

WHAT IS IN THIS LEAFLET? 

This leaflet answers some common questions about the ARTISS
FIBRIN SEALANT, TWO-
COMPONENT FIBRIN SEALANT, DEEP-FROZEN. It does
not contain all of the available 
information. All medicines have risks and benefits. Your doctor
has weighed the risks 
against the benefits for you having ARTISS. 

It does not take the place of talking to your doctor
or pharmacist. If you have any 
concerns about having this medicine, ask your doctor
or pharmacist. 

WHAT ARTISS IS USED FOR? 

ARTISS is used as a tissue glue to join skin surfaces
in burns surgery. ARTISS is also 
used to join skin surfaces in face-lift surgery. 

HOW DOES ARTISS WORK? 

The blood coagulation factors in the composition of ARTISS are
the same as those found 
in normal healthy individuals. They are isolated from healthy
human plasma, except 
aprotinin, which is synthetically made. The components
are packed in a double-chamber 
syringe. One of the chambers contains Sealer Protein solution
while the other contains 
Thrombin solution. The double-chamber syringe is stored in a
deep frozen state. It will be 
warmed up to between 33°C -37°C just prior to use. 

BEFORE YOU ARE GIVEN ARTISS 

_ARTISS SHOULD NOT BE GIVEN TO YOU IF:  _
  you have a tendency to allergic reactions or
hypersensitivity to aprotinin or any of the 
ingredients in this medicine
(listed under _What is in ARTISS?)_. Some of the symptoms 
of an allergic reaction may include
skin rash, swelling of the face, lips or tongue, 
which may cause difficulty swallowing or shortness of breath.  
  the expiry date printed on the pack has passed. 

_YOU MUST TELL YOUR DOCTOR IF YOU:_ 
  h

Summary of Product characteristics

ARTISS (frozen, fibrin sealant syringe) 

Product Information 

ARTISS PI 130731 

Page 1 of 17 

ARTISS 
NAME OF THE MEDICINE 
Two-Component Fibrin Sealant, Deep-Frozen, Vapour Heated (VH) and
Solvent Detergent (S/D) 
treated.  
DESCRIPTION 
ARTISS is a two-component fibrin sealant made from pooled human
plasma. The two components 
of ARTISS are formulated as two sterile, deep-frozen solutions. Each
solution is presented in a 
separate preloaded chamber of one double-chamber syringe: chamber one
[1] contains Sealer 
Protein Solution (with Aprotinin), deep frozen (1mL, 2mL or 5mL),
chamber two [2] contains 
Thrombin Solution (with Calcium Chloride), deep frozen (1mL, 2mL or
5mL), resulting  in 2mL, 
4mL or 10mL total volume of product ready for use.  
COMPOSITION OF THE ACTIVE INGREDIENTS OF ARTISS:  

(1) SEALER PROTEIN SOLUTION 1 mL of the solution contains: 
Active ingredients 
Quantity 

As total protein 
96 – 125 mg 
  Thereof 
Fibrinogen 
(Clottable 
  Protein) 
72 – 110 mg 

Factor XIII (human) 
1.2 – 10 IU 

Aprotinin, synthetic (Fibrinolysis 
 Inhibitor) 
3000 KIU
1

Excipients (see below) 

ARTISS contains Human Factor XIII co-purified with Human Fibrinogen in
a range of 1.2 - 10.0 
IU/mL. 

(2) THROMBIN SOLUTION: 1 mL of the solution contains: 
Active ingredients 
Quantity 

1
   KIU = Kallidinogenase Inactivator Unit 
ARTISS (frozen, fibrin sealant syringe) 

Product Information 

ARTISS PI 130731 

Page 2 of 17 

Thrombin (human) 
4 IU
2

Calcium Chloride (2 H
2
O) 40 
µmol 
Excipients (see below) 

The 2 components of ARTISS are colourless to pale yellow, opalescent
when frozen and clear to 
slightly turbid solutions once defrosted. 
COMPOSITION OF THE EXCIPIENTS OF ARTISS: 
(1) SEALER PROTEIN S