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ARTISS SOLUTIONS FOR SEALANT DEEP FROZEN

Active substance(s): APROTININ / CALCIUM CHLORIDE / HUMAN FIBRINOGEN / HUMAN THROMBIN

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0001893
PACKAGE LEAFLET: INFORMATION FOR THE USER

ARTISS Solutions for Sealant
Deep frozen
Active Substances: Human Fibrinogen, Human Thrombin, Aprotinin,
Calcium Chloride.
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:
• ARTISS must not be used for massive or brisk bleeding.
• ARTISS is not indicated to replace skin sutures intended to close a surgical
wound.
• ARTISS is not indicated for use in neurosurgery and as a suture support for
gastrointestinal anastomoses or vascular anastomoses as no data are available
to support these indications.
• ARTISS MUST NOT be injected into blood vessels (veins or arteries), or into
tissues. As ARTISS forms a clot where it is applied, injecting ARTISS may
cause serious reactions (e.g. vessel occlusion). ARTISS should only be applied
to the surface of tissues as a thin layer where it is needed.
• You must not receive ARTISS if you are allergic (hypersensitive) to the active
substances, to bovine protein or any of the other ingredients (see section 6) of
ARTISS. It may cause serious allergic reactions.
Please inform your doctor or surgeon if you know that you are allergic against
aprotinin or any bovine protein.
Warnings and precautions
• ARTISS should not be used in laparoscopic surgery (keyhole surgery).
• Life-threatening/fatal air or gas embolism (air getting into the blood
circulation which can be serious or life-threatening) has occurred with the
use of spray devices employing pressure regulators to administer fibrin
sealants. This appears to be related to the use of the spray device at higher
than recommended pressures and/or in close proximity to the tissue surface.
The risk appears to be higher when fibrin sealants are sprayed with air, as
compared to CO2 and therefore cannot be excluded with ARTISS.
• When ARTISS is applied using a spray device, the pressure and spraying
distance have to be within the range recommended by the manufacturer.
ARTISS should be administered strictly according to the instructions and only
with devices recommended for this product.
• When spraying ARTISS, changes in blood pressure, pulse, oxygen saturation
and end tidal CO2 should be monitored for possible occurrence of gas
embolism.
• ARTISS must not be used with the Easy Spray/Spray Set system in enclosed
body areas.
• ARTISS should be applied only with CE marked application devices.

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• If you have ever received ARTISS or aprotinin before, your body may have
become sensitive to it. It is possible you may be allergic to this material, even
if there was no reaction to the first application. If you think you have received
either product in a previous operation, you have to inform your doctor about this.
• If there is any sign of an allergic reaction, your doctor will stop the use of
ARTISS immediately and give appropriate treatment.
• Before administration of ARTISS parts of the body outside the designated
application area have to be sufficiently protected/covered to prevent unwanted
tissue adhesion.
• ARTISS is applied as a thin layer. Excessive clot thickness may negatively
interfere with the product’s efficacy and the wound healing process.
When medicines are made from human blood or plasma, certain measures are put
in place to prevent infections being passed on to patients. These include:
• careful selection of blood and plasma donors to make sure those at risk of
carrying infections are excluded,
• the testing of each donation and pools of plasma for signs of virus/infections,
• the inclusion of steps in the processing of the blood or plasma that can inactivate
or remove viruses.
Despite these measures, when medicines prepared from human blood or plasma
are administered, the possibility of passing on infection cannot be totally excluded.
This also applies to any unknown or emerging viruses or other types of infections.
The measures taken are considered effective for enveloped viruses such as
human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and
for the non-enveloped hepatitis A virus. The measures taken may be of limited
value against non-enveloped viruses such as parvovirus B19. Parvovirus B19
infection may be serious for pregnant women (fetal infection) and for individuals
whose immune system is depressed or who have some types of anaemia (e.g.
sickle cell disease or haemolytic anaemia).
It is strongly recommended that every time you receive a dose of ARTISS the
name and batch number of the product are recorded in order to maintain a record
of the batches used.
Other medicines and ARTISS
ARTISS can be used when you are receiving other medical products. There are
no known interactions between ARTISS and other medicinal products. Your doctor
will not use oxycellulose-containing preparations as carrier materials as they may
reduce the efficacy of ARTISS.
Please tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
ARTISS with food and drink
Please ask your doctor. The doctor will decide if you are allowed to eat and drink
before the application of ARTISS.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning
to have a baby ask your doctor for advice. Your doctor will decide if you can use
ARTISS during pregnancy or breast-feeding.
Driving and using machines
ARTISS will not affect your ability to drive or operate other types of machines.
3. How to use ARTISS
• ARTISS is only applied during a surgical operation. The use of ARTISS is
restricted to experienced surgeons who have been trained in the use of ARTISS.
• The amount of ARTISS that will be used depends on a number of factors,
including the type of surgery, the surface area of tissue to be treated during your
operation and the way ARTISS is applied. The surgeon will decide how much is
appropriate.
• During your operation, the surgeon will apply ARTISS onto the relevant tissue
surface, using the special application device provided. This device ensures that
equal amounts of both fibrin sealant components are applied at the same time –
which is important for the optimal effect of ARTISS.
• Prior to applying ARTISS the surface area of the wound needs to be dried by
standard techniques (e.g. intermittent application of compresses, swabs, use of
suction devices).
• ARTISS must be sprayed only onto application sites that are visible.
• It is recommended that the initial application covers the entire intended
application area.
When applying ARTISS using a spray device be sure to use a pressure and a
distance from the tissue within the range recommended by the manufacturer
as follows:
Recommended pressure, distance and devices for spray application of
ARTISS
Spray set
to be used

Open
wound
surgery
of subcutaneous
tissue

RecomRecommended
Applicator Pressure
tips to be regulator to distance mended spray
pressure
be used from target
used
tissue

Tisseel/
Artiss
Spray Set
Tisseel/
Artiss
Spray Set
10 pack

0001893_UK-IE_V2.indd 2

n.a.

EasySpray
10 – 15 cm

n.a.

EasySpray

1.5 – 2.0 bar
(21.5 –
28.5 psi)

26.08.15 13:27

When spraying the ARTISS, changes in blood pressure, pulse, oxygen
saturation and end tidal CO2 should be monitored because of the possibility of
occurrence of air or gas embolism (see section 2).
If you use more ARTISS than you should
ARTISS is only applied during a surgical operation. It is applied by the surgeon
and the amount of ARTISS is determined by the surgeon.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them. The following table explains what is meant with a certain frequency, as
given in the following section:
very common:

may affect more than 1 in 10 people

common:

may affect up to 1 in 10 people

uncommon:

may affect up to 1 in 100 people

rare:

may affect up to 1 in 1,000 people

very rare:

may affect up to 1 in 10,000 people

not known:

frequency cannot be estimated from the available data

• There is a slight possibility that you might have an allergic reaction to one of
the components of ARTISS (see section 6). This is more likely if you have been
treated with ARTISS or aprotinin during a previous operation. Allergic reactions
can be serious, and it is very important that you discuss this possibility in detail
with your doctor.
• Allergic reactions of the anaphylactic/anaphylactoid type may occur, frequency
of this is not known. Early symptoms of allergic reactions can be: flushing, a
fall in blood pressure, increased or decreased pulse rate, nausea (feeling sick),
hives, itching, difficulty breathing.
• The surgical team treating you will be aware of the risk of this type of
reaction – if they see any symptoms, the application of ARTISS will be
stopped immediately. Severe symptoms may require emergency treatment.
The frequency for allergic reactions is not known.
• If ARTISS is injected into soft tissues, it can cause local tissue damage.
Frequency is not known.
• If ARTISS is injected into blood vessels (veins or arteries), it can cause clots to
form (thrombosis). Frequency is not known.
• As ARTISS is made from plasma from blood donations, the risk of infection
cannot be totally excluded, but the manufacturer undertakes numerous
measures to reduce the risk (see section 2).
Adverse reactions reported from clinical studies of ARTISS and from postmarketing experience with Baxter Fibrin Sealants are summarized in the following.
Known frequencies of these adverse reactions are based on a controlled clinical
study in 138 patients where skin grafts were fixed to excised burn wounds using
ARTISS. None of the events observed in the clinical study were classified as
serious.
Table 1
Adverse Reactions
Adverse Reaction

Frequency

Dermal cyst

uncommon

Itching

common

Skin graft failure

common

Gas bubbles in the vascular system (Air embolism)*

not known

* The introduction of air or gas bubbles in the blood stream (air embolism) has occurred when fibrin
sealants are applied with devices using pressurized air or gas; this is believed to be caused by
inappropriate use of the spray device (e.g. at higher than recommended pressure and in close
proximity to the tissue surface).

The following adverse reactions have been reported for other fibrin sealants,
frequencies of those cannot be provided: Allergy, severe allergic reaction, slow
heart rate, fast heart rate, decrease in blood pressure, effusion of blood, shortness
of breath, sickness, hives, flushing, impaired healing, swelling, fever, and
accumulation of lymph and other clear body fluids under the skin near the surgical
site.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed
below.
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of
this medicine.

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Perforation

5. How to store ARTISS
• Keep this medicine out of the sight and reach of children.
• Store and transport frozen (at ≤ –20°C). The cold storage chain must not be
interrupted until use.
• Keep the syringe in the original package in order to protect from light.
• Do not use ARTISS after the expiry date, which is stated on the label.
Storing after thawing:
Unopened pouches, thawed at room temperature, may be stored for up to 14 days
at controlled room temperature (not exceeding +25°C).
After thawing, the solutions must not be refrozen or refrigerated!
ARTISS should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
6. Contents of the pack and other information
What ARTISS contains
ARTISS contains two components:
Component 1 = Sealer Protein Solution:
The active substances contained in 1ml of the Sealer Protein Solution are:
Human Fibrinogen, 91 mg/ml; synthetic Aprotinin 3000 KIU/ml.
The excipients are Human Albumin, L-Histidine, Niacinamide, Polysorbate 80,
Sodium Citrate Dihydrate and Water for Injections.
Component 2 = Thrombin Solution:
The active substances contained in 1 ml of the Thrombin Solution are:
Human Thrombin, 4 IU/ml; Calcium Chloride, 40 μmol/ml.
The excipients are Human Albumin, Sodium Chloride and Water for Injections.
After mixing
Component 1:
Sealer protein solution
Human Fibrinogen
(as clottable protein)
Aprotinin (synthetic)
Component 2:
Thrombin Solution
Human Thrombin
Calcium Chloride

1 ml

2 ml

4 ml

10 ml

45.5 mg

91 mg

182 mg

455 mg

1,500 KIU

3,000 KIU

6,000 KIU

15,000 KIU

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.
What ARTISS looks like and the contents of the pack
Frozen solutions for sealant (1 ml, 2 ml, or 5 ml of sealer protein solution and 1,
2 or 5 ml of Thrombin Solution in a single-use double-chamber syringe in a
bag, and one device set with one double syringe plunger, 2 joining pieces and
4 application cannulae. Pack size of 1.).
The solution is colorless or pale yellow.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Tel 01635 206345
Fax 01635 206071
e-mail surecall@baxter.com
Manufacturer
Baxter AG
Industriestraße 67
A-1221 Vienna
Austria
This medicinal product is authorized in the Member States of the EEA under the
following names:
ARTISS for the following countries: AT, BE, CZ, DE, EL, ES, FI, FR, IE, IT, LU, NL,
NO, PL, PT, UK
Artiss in DK, IS, SE
АРТИС (ARTISS) in BG
This leaflet was last revised in: July 2015

0001893_UK-IE_V2.indd 4

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The following information is intended for medical or healthcare
professionals only:
Fertility, pregnancy and lactation
The safety of fibrin sealants/haemostatics for use in human pregnancy or
breastfeeding has not been established in controlled clinical trials. Animal studies
have also not been performed.
Therefore, the product should be administered to pregnant and lactating women
only if clearly needed.
The effects of ARTISS on fertility have not been established.
Posology and method of administration
ARTISS is intended for hospital use only. The use of ARTISS is restricted to
experienced surgeons who have been trained in the use of ARTISS.
Posology
The amount of ARTISS 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 and the mode of intended
application, and the number of applications.
Application of the product must be individualized by the treating physician. In
clinical trials, the individual dosages have typically ranged from 0.2 – 12 ml. For
some procedures (e.g. the sealing of large burned surfaces), larger volumes may
be required.
The initial amount of the product to be applied at a chosen anatomic site or target
surface area should be sufficient to entirely cover the intended application area.
The application can be repeated, if necessary, to any small areas that may not
have been previously treated.
It is recommended that the initial application covers the entire intended application
area.
As a guideline for the gluing of surfaces, 1 pack of ARTISS 2 ml (i.e., 1 ml Sealer
Protein Solution plus 1 ml Thrombin Solution) will be sufficient for an area of at
least 10 cm2.
The skin graft should be attached to the wound bed immediately after ARTISS has
been applied. The surgeon has up to 60 seconds to manipulate and position the
graft prior to polymerization. After the flap or graft has been positioned, hold in the
desired position by gentle compression for at least 3 minutes to ensure ARTISS
sets properly and the graft or flap adheres firmly to the underlying tissue.
The required amount of ARTISS depends on the size of the surface to be covered.
The approximate surface areas covered by each pack size of ARTISS by spray
application are:
Approximate area requiring tissue adherence Required pack size of ARTISS
100 cm2
2 ml
200 cm2
4 ml
500 cm2
10 ml
To avoid the formation of excess granulation tissue and to ensure gradual
absorption of the solidified fibrin sealant, only a thin layer of the mixed Sealer
Protein – Thrombin Solution, should be applied.
ARTISS has not been administered to patients > 65 years old in clinical trials.
Paediatric Population
Currently available data are described in section 5.1 of the SmPC but no
recommendation on a posology can be made.
Method of administration
For epilesional (topical) use. Do not inject.
For subcutaneous use only. ARTISS is not recommended for laparoscopic surgery.
In order to ensure optimal safe use of ARTISS it should be sprayed using
a pressure regulator device that delivers a maximum pressure of up to 2.0 bar
(28.5 psi).
Prior to applying ARTISS the surface area of the wound needs to be dried by
standard techniques (e.g. intermittent application of compresses, swabs, use of
suction devices). Do not use pressurized air or gas for drying the site.
ARTISS must be sprayed only onto application sites that are visible.
ARTISS should only be reconstituted and administered according to the
instructions and with the devices recommended for this product.
For spray application, see section Administration below.
Before administration of ARTISS care is to be taken that parts of the body outside
the designated application area are sufficiently protected/covered to prevent tissue
adhesion at undesired sites.
Special precautions for disposal and other handling
General
To prevent ARTISS from adhering to gloves and instruments, wet these with
sodium chloride solution before contact.
As a guideline for the gluing of surfaces, 1 pack of ARTISS 2 ml (i.e., 1 ml Sealer
Protein Solution plus 1 ml Thrombin Solution) will be sufficient for an area of at
least 10 cm2.
The required dose of ARTISS depends on the size of the surface to be covered.
Handling and Preparation
The inner bag and its contents are sterile unless the integrity of the outside
package is compromised.

0001893_UK-IE_V2.indd 5

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Perforation

It is recommended to thaw and warm the two sealant components using a sterile
water bath at a temperature of 33 – 37°C. The water bath must not exceed a
temperature of 37°C. (In order to control the specified temperature range, the
water temperature should be monitored using a thermometer and the water
should be changed as necessary. When using a sterile water bath for thawing and
warming, the pre-filled double chamber syringe assembly should be removed from
the aluminum-coated plastic bags.)
The protective syringe cap should not be removed until thawing is complete and the
joining piece is ready to be attached. Do not use ARTISS unless it is completely
thawed and warmed (liquid consistency).
Thaw pre-filled syringes using one of the following options:
I. Room Temperature Thawing (not exceeding +25°C):
The product can be thawed at room temperature. Times given in Table 1 are
minimum times for thawing at room temperature. The maximum time the product
can be kept (in both aluminum-coated plastic bags) at room temperature is 14 days.
When thawing at room temperature, the product must be additionally warmed to
33°C – 37°C in an incubator just before use. Respective warming times in the
incubator are also given in Table 1.
Table 1: Thawing times at Room Temperature (= RT) followed by additional
warming, prior to use, in an Incubator at 33°C to a maximum of 37°C
Warming Times at
33 – 37°C in Incubator
after Thawing at RT
(Product in aluminumcoated plastic bags)

Pack Size

Thawing Times at Room
Temperature (Product in
aluminum-coated plastic
bags)

2 ml

60 minutes

+

15 minutes

4 ml

110 minutes

+

25 minutes

10 ml

160 minutes

+

35 minutes

Once ARTISS has been warmed up to 33 – 37°C the product may be stored for up
to 4 hours.
II. Quick Thawing:
Table 2: Thawing and Warming Times with Sterile Water Bath at 33°C to a
maximum of 37°C
Transfer plunger and the inner pouch to the sterile field, remove prefilled syringe
from inner pouch and place directly into sterile water bath. Ensure the contents of
the prefilled syringe are completely immersed in water.
Pack Size

Thawing and Warming Times
(Product removed from aluminum-coated
plastic bags)

2 ml

5 minutes

4 ml

5 minutes

10 ml

12 minutes

A third alternative is to thaw the product off the sterile field using a non-sterile
water bath. Maintain the prefilled syringe in both pouches and place into a water
bath off the sterile field for an appropriate time (see Table 3). Ensure the pouches
remain submerged throughout thawing. Remove from the water bath after thawing,
dry external pouch and transfer inner pouch with prefilled syringe and plunger to
the sterile field.
Table 3: Thawing and Warming times off the Sterile Field with Non-Sterile Water
Bath at 33°C to a maximum of 37°C
Pack Size

Thawing and Warming Times
(Product in aluminum-coated plastic bags)

2 ml

30 minutes

4 ml

40 minutes

10 ml

80 minutes

Alternatively, the sealant components may be thawed and warmed in an incubator
between 33°C and 37°C. The thawing and warming times in the incubator are
indicated in Table 4 below. The times refer to product in the aluminum-coated
plastic bags.
Table 4: Thawing and Warming Times in Incubator at 33°C to a maximum of 37°C

Note:

Pack Size

Thawing and Warming Times in Incubator
(Product in aluminum-coated plastic bags)

2 ml

40 minutes

4 ml

85 minutes

10 ml

105 minutes

Do not thaw by holding product in your hands.
Do not microwave.
After thawing do not refrigerate or refreeze.

0001893_UK-IE_V2.indd 6

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After Quick Thawing (i.e. thawing at a temperature of 33 – 37°C) ARTISS may be
stored at 33 – 37°C for a maximum of 4 hours.
To facilitate optimal blending of the two solutions, the two sealant components
must be warmed to 33 – 37°C immediately before use. (The temperature of 37°C
must, however, not be exceeded!)
The Sealer Protein and the Thrombin Solutions should be clear or slightly
opalescent. Do not use solutions that are cloudy or have deposits. Thawed
products should be inspected visually for particulate matter and discoloration prior
to administration or any variation in physical appearance. In the event of either
being observed, discard the solution.
The thawed Sealer Protein Solution should be a slightly viscous liquid. If the
solution has the consistency of a solidified gel, it must be assumed to have become
denatured (e.g., due to an interruption of the cold storage chain or by overheating
during warming). In this case, ARTISS must not be used.
Unopened pouches, thawed at room temperature, may be stored for up to 14 days
at controlled room temperature (not exceeding +25°C). If not used within 14 days
after thawing, ARTISS has to be discarded.
The protective syringe cap should not be removed until thawing is complete and the
joining piece is ready to be attached. Do not use ARTISS unless it is completely
thawed and warmed (liquid consistency).
For further preparation instructions please refer to the responsible nurse or
medical doctor.
Administration
For application, the double-chamber syringe with the Sealer Protein Solution and
the Thrombin Solution has to be connected to a joining piece and an application
cannula as provided in the accompanying set of devices. The common plunger
of the double-chamber syringe ensures that equal volumes are fed through the
joining piece before being mixed in the application cannula and ejected.
Operating Instructions

Tether Strap

Double Plunger
Double Chamber Syringe

Joining piece
Application Canula
– Connect the nozzles of the double-chamber syringe to the joining piece
ensuring that they are firmly fixed. Secure the joining piece by fastening the
tether strap to the double-chamber syringe. If the tether strap tears, use the
spare joining piece. If none is available, further use is still possible but tightness
of the connection needs to be ensured to prevent any risk of leaking.
– Fit an application cannula onto the joining piece.
– Do not expel the air remaining inside the joining piece or application cannula
until you start actual application as the aperture of the cannula may clog
otherwise.
– Immediately before application expel and discard the first several drops from the
application cannula to ensure adequately mixed product.
– Apply the mixed Sealer Protein - Thrombin Solution onto the recipient surface or
surfaces of the parts to be sealed.
If application of the fibrin sealant components is interrupted, clogging may occur
in the cannula. Replace the application cannula with a new one only immediately
before application is resumed. If the apertures of the joining piece are clogged, use
the spare joining piece provided in the package.
Spray application
When applying ARTISS using a spray device be sure to use a pressure and a
distance from tissue within the ranges recommended by the manufacturer as
follows:
Recommended pressure, distance and devices for spray application of
ARTISS
Spray set
to be used

Open
wound
surgery
of subcutaneous
tissue

RecomRecommended
Applicator Pressure
tips to be regulator to distance mended spray
pressure
be used from target
used
tissue

Tisseel/
Artiss
Spray Set
Tisseel/
Artiss
Spray Set
10 pack

0001893_UK-IE_V2.indd 7

n.a.

EasySpray
10 – 15 cm

n.a.

EasySpray

1.5 – 2.0 bar
(21.5 –
28.5 psi)

26.08.15 13:27

When spraying the ARTISS, changes in blood pressure, pulse, oxygen saturation
and end tidal CO2 should be monitored because of the possibility of occurrence
of air or gas embolism.
Application is also possible with other accessories supplied by BAXTER that
are particularly suited for, e.g. minimally invasive surgery, application to large or
difficult-to-access areas. When using these application devices, strictly follow the
Instructions for Use of the devices.
After the two components have been applied, approximate the wound areas. The
skin graft should be attached to the wound bed immediately after ARTISS has
been applied. The surgeon has up to 60 seconds to manipulate and position the
graft prior to polymerization. After the flap or graft has been positioned, hold in the
desired position by gentle compression for at least 3 minutes to ensure ARTISS
sets properly and the graft or flap adheres firmly to the underlying tissue.
Disposal
Any unused product or waste material should be disposed of in accordance with
local requirements.

0001893_UK-IE_V2.indd 8

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Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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