SUMMARY CMI
ARTISS
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor, nurse or pharmacist.
1. Why am I receiving ARTISS?
ARTISS is a fibrin sealant with the active ingredients fibrinogen, thrombin, aprotinin, factor XIII and calcium chloride dihydrate. It is used as a tissue glue to join skin surfaces in burn patients or in face-lift surgery.
For more information, see Section 1. Why am I receiving ARTISS? in the full CMI.
2. What should I know before I am given ARTISS?
Do not use if you have ever had an allergic reaction to aprotinin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given ARTISS? in the full CMI.
3. What if I am taking other medicines?
There are currently no medicines known to interact with ARTISS.
See Section 3. What if I am taking other medicines? in the full CMI.
4. How is ARTISS used?
- Your surgeon will apply ARTISS as needed during your surgical operation.
- Your surgeon will decide how much ARTISS will be applied, depending on your individual need.
- More instructions can be found in Section 4. How is ARTISS used? in the full CMI.
5. What should I know after having ARTISS?
Things you should do |
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Looking after your medicine |
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For more information, see Section 5. What should I know after having ARTISS? in the full CMI.
6. Are there any side effects?
Serious side effects include sudden allergic reactions (early symptoms can be flushing, increased or decreased pulse rate, hives, itching, or difficulty breathing). An allergic reaction is more likely if ARTISS has been used in a previous surgery. Allergic reactions can be life-threatening.
Products like ARTISS can be applied with spray devices. Improper use of spray devices can cause air to get into the blood circulation. This side effect can be life-threatening.
Common side effects include skin graft failure and itchy skin.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
ARTISS (frozen) fibrin sealant syringe
Active ingredients: fibrinogen, thrombin, aprotinin, factor XIII and calcium chloride dihydrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using ARTISS. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about using ARTISS.
Where to find information in this leaflet:
1. Why am I receiving ARTISS?
2. What should I know before I am given ARTISS?
3. What if I am taking other medicines?
4. How is ARTISS used?
5. What should I know after having ARTISS?
6. Are there any side effects?
7. Product details
1. Why am I receiving ARTISS?
ARTISS is a fibrin sealant containing the active ingredients fibrinogen, thrombin, aprotinin, factor XIII and calcium chloride dihydrate.
ARTISS is used as a tissue glue to join skin surfaces in:
- burn patients (using their own skin grafts)
- face-lift surgery patients.
2. What should I know before I am given ARTISS?
Warnings
You should not be given ARTISS if:
- you are hypersensitive to aprotinin, or any of the ingredients listed at the end of this leaflet.
Check with your doctor if you:
- have any other medical conditions
- tend to have allergic reactions
- take any medicines for any other condition
- have been given aprotinin or fibrin sealant in a previous surgical operation.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Use in children
As in adults, ARTISS is considered safe and effective for child burn patients in procedures to attach their own skin grafts. However, the safety profile of ARTISS for children during facial plastic and reconstructive surgeries involving skin flaps and grafts is not fully known.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ARTISS.
There are currently no medicines known to interact with ARTISS.
4. How is ARTISS used?
How it is used
- Your surgeon will apply ARTISS as needed during your surgical operation. The surgeon uses ARTISS only during specific procedures to join skin surfaces.
How much is given
- Your surgeon will decide how much ARTISS will be applied, depending on your individual need.
If too much ARTISS is used
ARTISS is applied by your surgeon as a tissue glue only on the tissue surface (local application). It is unlikely that your surgeon will use too much (overdose).
No symptoms of overdose are known for ARTISS.
5. What should I know after having ARTISS?
Things you should do
Talk to your doctor and surgeon about how you feel after the surgical operation.
Since ARTISS is given in a hospital, your healthcare provider will monitor your progress and any side effects.
Looking after your medicine
You will not have to store or handle this medicine.
This medicine is stored in the hospital pharmacy, kept at minus 18°C or colder and protected from light. Medical professionals handle and prepare it according to the manufacturer's instructions.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
Skin-related:
Followed about two weeks later by:
Followed by:
| Speak to your doctor if you have any of these less serious. |
Serious side effects
Serious side effects | What to do |
Allergic reaction-related:
| Call the doctor on duty straight away if you notice the symptoms of an allergic reaction. Go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
7. Product details
This medicine is only available with a doctor's prescription. It is only used in a hospital setting, during specific surgical operations.
What ARTISS contains
ARTISS contains synthetic and human plasma proteins. Human proteins have been isolated from the pooled blood of healthy donors according to World Health Organisation (WHO) guidelines.
The active components are filled in two separate chambers of a double-chamber syringe. These chambers contain the Sealer Protein Solution and the Thrombin Solution (see table below).
Active ingredients (main ingredients) | Sealer Protein Solution
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Other ingredients (inactive ingredients) | Sealer Protein Solution Human albumin, Histidine, Sodium Citrate, Polysorbate 80, Nicotinamide, Water for Injections Thrombin Solution Sodium Chloride, Human Albumin, Water for Injections |
Potential allergens | Aprotinin |
Do not take this medicine if you are allergic to any of these ingredients.
What ARTISS looks like
ARTISS is a frozen, two-component fibrin sealant, supplied in a single-use double-chamber syringe packed in two bags and one device set with 2 joining pieces and 4 application cannulas.
ARTISS is available in 2.0 mL, 4.0 mL, and 10.0 mL package sizes. (Aust R 163515).
Who distributes ARTISS
Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie
NSW 2146
This leaflet was prepared in June 2025
Baxter and Artiss are trademarks of Baxter International Inc.
Published by MIMS August 2025