ARTISS is a fibrin sealant indicated to:

•

Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age.

•

Adhere tissue flaps during facial rhytidectomy surgery (face-lift).

ARTISS is not indicated as an adjunct to hemostasis.

For topical use only.

2.2 Method of Application

ARTISS must be applied only to application sites that are visible. Individualize the amount to be applied based on the size of the surface to be covered. Prior to applying ARTISS, dry the site of application using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices). Do not use pressurized air or gas for drying the site. Apply ARTISS as a thin layer.

The approximate surface areas covered by each package size are:

Table 3

Approximate area requiring skin graft fixation	Required package size of ARTISS
100 cm2 200 cm2 500 cm2	2 mL 4 mL 10 mL

When applying ARTISS using a spray device, utilize the recommended gas, pressure and distance from tissue within the ranges recommended by the manufacturer as follows:

Table 4: Recommended Application Equipment, Gas and Parameters.

* Medical grade CO2 is the preferred gas for application, however Compressed Air or Nitrogen are acceptable gasses for administration of ARTISS in open surgery.
Surgery	Spray Set / Applicator tips to use	Pressure regulator to use	Gas	Distance	Spray Pressure
Open surgery	TISSEEL/ARTISS Spray Set	EASY SPRAY pressure Regulator	Medical grade CO2*, Compressed Air or Nitrogen	10-15 cm	1.5-2.0 bar (21.8-29.0 psi)

Application with Spray Device

Apply using the EASYSPRAY and Spray Set, or an equivalent device cleared by FDA for application of ARTISS. See additional instructions for use provided with the EASYSPRAY and Spray Set. Artiss must not be used with the EASYSPRAY / Spray Set system in enclosed body cavities.

Ensure that parts of the body outside the desired application area are sufficiently covered to prevent tissue adherence at undesired site.

Apply as a thin layer to avoid the formation of excess granulation tissue and to ensure gradual absorption of the polymerized fibrin sealant. Excessive clot thickness may delay the natural wound healing process. Ensure that the amount applied is sufficient to entirely cover the intended application area.

The aerosolized sealant should be applied to the wound in a painting motion from side to side to achieve an even thin layer. The wound bed will glisten in the area to which fibrin sealant has been applied. Any areas not covered by fibrin sealant will be clearly visible.

Attach the skin flap or graft to the wound bed immediately after ARTISS has been sprayed. Wet gloves with normal saline before product contact to prevent adherence. The surgeon has up to 60 seconds to manipulate and position the flap or graft prior to polymerization.

Repeat application, if necessary, to any small areas that may not have been previously treated.

Hold the flap or graft in the desired position by gentle compression for at least 3 minutes to ensure ARTISS sets properly and firmly adheres the skin graft or flap to the underlying tissue. The solidified fibrin sealant reaches its final strength in approximately 2 hours after application.

Application with DUO Set A (AST Syringe) and DUPLOJECT COMBI (PRIMA Syringe)

The cannulas included with the DUO Set A and DUPLOJECT COMBI may be used for small wounds or for edges of a skin graft that did not adhere to the wound bed [see Warnings and Precautions (5.3)]. Immediately before application, expel and discard the first several drops from the application cannula to ensure adequate mixing of the Sealer Protein and Thrombin solutions in cases where very small volumes (1-2 drops) are administered.

DUO Set A (AST Syringe) Instructions (see Figure 1):

1.

Insert Plunger into syringe barrel.

2.

Expel all air from the syringe prior to attaching any application device.

3.

Align the joining piece and tether to the side of the syringe with the tether strap hole.

4.

Connect the nozzles of the double chamber ready-to-use syringe to the joining piece, ensuring that they are firmly attached.

5.

Secure the joining piece by fastening the tether strap to the double chamber ready-to-use syringe.

6.

If the tether strap tears, use the spare joining piece provided in the kit.

7.

Do NOT expel the air remaining inside the joining piece.

8.

Attach an application cannula on to the joining piece.

9.

Do NOT expel the air remaining inside the joining piece and inside the application cannula until the start of the actual application because this may clog the application cannula.

DUPLOJECT COMBI (PRIMA Syringe) Instructions (see Figure 2)

1.

The plunger is attached to the syringe barrel and does not need to be inserted.

2.

Expel all air from the syringe prior to attaching any application device.

3.

Align the joining piece and tether to the side of the syringe with the tether strap hole.

4.

Connect the nozzles of the double chamber ready-to-use syringe to the joining piece, ensuring that they are firmly attached.

5.

Secure the joining piece by fastening the tether strap to the double chamber ready-to-use syringe.

6.

If the tether strap tears, use the spare joining piece provided in the kit.

7.

Do NOT expel the air remaining inside the joining piece.

8.

Attach an application cannula on to the joining piece.

9.

Do NOT expel the air remaining inside the joining piece and inside the application cannula until the start of the actual application because this may clog the application cannula.

Note: Interruption of application causes clogging in the cannula. Replace the cannula immediately prior to resuming application. If the opening of the joining piece (Y connector) facing the cannula is clogged, use the spare joining piece provided in the package.

Figure 1: DUO Set A (AST Syringe)

Figure 2: DUPLOJECT COMBI (PRIMA Syringe)

Pre-filled syringes are for single use only. Discard unused contents.

When using application devices cleared by FDA for use with ARTISS, strictly follow the Instruction for Use of the device.

ARTISS is a two component fibrin sealant solution, comprised of sealer protein (human) and thrombin (human) available in a 2 mL, 4 mL, or 10 mL (total volume) pre-filled syringe with the DUO Set A (AST Syringe) or DUPLOJECT COMBI (PRIMA Syringe).

Do not inject directly into the circulatory system or into highly vascularized tissue. Intravascular application can result in life-threatening thromboembolic events and can increase the likelihood and severity of acute hypersensitivity reaction in susceptible patients.

Do not use in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients of ARTISS including proteins such as fibrinogen, thrombin, and human albumin [see Warnings and Precautions (5.1) and Adverse Reactions (6)].

Do not spray where the minimum recommended distance from the applicator tip to the target site cannot be assured.

The most frequent (≥ 1% of clinical trial subjects) adverse reactions with the use of ARTISS were: Skin graft failure, hematoma and pruritus in burn studies, and hematoma/seroma in rhytidectomy studies.

Oxycellulose containing preparations may reduce the efficacy of ARTISS and should not be used as carrier materials. No interaction studies have been performed.

To avoid the formation of excess granulation tissue and to ensure gradual absorption of the polymerized fibrin sealant, apply only a thin layer [ Dosage and Administration (2.2)].

ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma.

Sealer Protein Solution
Total protein: 96 -125 mg/mL
Fibrinogen: 67 - 106 mg/mL
Fibrinolysis Inhibitor (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL

Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI).

Thrombin Solution
Thrombin (Human): 2.5 - 6.5 units/mL1
Calcium Chloride: 36 - 44 µmol/mL
Other ingredients include: Human albumin, sodium chloride and water for injection (WFI).

1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU).

Sealer Protein (Human)

Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin.

Thrombin (Human)

Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2).

Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)].

Viral Clearance

The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein Concentrate and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV, HBV, HCV, HAV and Human Parvovirus B19.

The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 6 for each of the viruses tested:

n.d. = not determined

HIV-1: Human immunodeficiency virus 1; HAV: Hepatitis A virus; BVDV: Bovine viral diarrhea virus, a model for Hepatitis C virus; PRV: Pseudorabies virus, a model for enveloped DNA viruses, among those Hepatitis B virus; MMV: Mice minute virus, a model for B19V.

In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.

Burns (grafts)

ARTISS was investigated for adherence of split thickness sheet skin grafts in burn patients in a prospective, randomized, controlled, evaluator-blinded, multicenter clinical trials. In each of the 138 patients, two comparable test sites were identified after burn wound excision. Skin grafts were adhered at one test site using ARTISS, and at the other test site using staples (control). The study product was applied once to the wound bed of the allocated test site during skin grafting surgery.

The mean ± standard deviation (SD) estimated total body surface area (TBSA) for all burn wounds was 13.6 ± 9.2%. The mean ± SD estimated TBSA requiring skin grafting was 8.0 ± 6.9%. The mean ± SD estimated TBSA for ARTISS test sites was 1.7 ± 0.8% and for the stapled test sites was 1.7 ± 0.7%. Burn wound thickness was classified as full thickness in 106 (76.8%) of the 138 treated subjects, and partial thickness in 32 (23.2%) subjects.

The safety population contained all 138 treated subjects; however, 11 subjects did not have an available primary endpoint assessment, leaving a modified intent-to-treat (ITT) set of 127 patients. Complete wound closure by Day 28 was achieved in 43.3% of the ARTISS test sites and 37.0% of the stapled test sites in the 127 ITT patients. Wound closure at Day 28 was complete at 72% of the ARTISS and staples test sites for the 1-6 years old group (N=18), at 32% of the ARTISS test sites and 26% of the staples test sites for the 7-18 years old group (N=19) and at 40% of the ARTISS test sites and 32% of the staples test sites for the greater then 18 years old group [ITT]. The lower limit of the 97.5% confidence interval of the difference between ARTISS and staples was -0.029. A similar result was obtained in the per protocol (PP) population: complete wound closure by Day 28 was achieved in 45.3% of the ARTISS test sites and 39.6% of the stapled test sites in the 106 PP patients. The lower limit of the 97.5% confidence interval of the difference between ARTISS and staples was -0.041. Therefore, ARTISS was found to be non-inferior to staples in the ITT and PP populations at the 97.5% one-sided level for complete wound closure by Day 28 because the lower limit of the confidence interval of the difference between ARTISS and staples success rates was greater than the predefined limit of -0.1.

Facial Rhytidectomy (flaps)

ARTISS was investigated for adherence of skin flaps in facial rhytidectomy surgeries during two prospective, randomized, controlled, multicenter clinical trials. Both the preliminary trial investigating 45 subjects and the confirmatory trial with 75 subjects had a split-face design in which 1 side of the face was treated with ARTISS as an adjunct to the standard of care (SoC) and the other side received SoC only, which was closure of the flap by means of staples and suturing only; therefore each subject participated in both arms (ARTISS and SoC).

Primary endpoint of the confirmatory trial conducted in 75 subjects was the total drainage volume collected from each side of the face at 24 h (±4 h) post surgery. Occurrence of hematoma and seroma on each side of the face, comparison of edema between the 2 sides of the face, changes in skin sensitivity from baseline on each side of the face and subject preference were evaluated as secondary endpoints.

In both trials, a standardized drain was placed in each side of the face prior to the flap closure and drainage volume from both sides of the face from all subjects was compared. Pressure dressings were not allowed.

The results for the primary endpoint of the confirmatory trial are presented in Table 7a below.

A statistically significant difference in drainage volumes was observed, favoring the side of the face treated with ARTISS.

Drainage volumes at 24 h post operatively for each side of the face reported as secondary endpoint in the preliminary trial are presented in Table 7b below.

An integrated analysis of the occurrence of hematoma/seroma in all 120 subjects across two trials was performed. A comparison of the proportion of subjects experiencing a hematoma/seroma exclusively on the ARTISS-treated side or on the SoC side of the face is presented in Table 8 below.

Storage

Store in original carton to protect from light. Do not use after the expiration date. Discard if packaging of any component is damaged.

•

Long term: Store at ≤ -20°C.

•

Short term: Room Temperature Thawing: Unopened pouches, thawed at room temperature, may be stored for up to 14 days at room temperature (15°C to 25°C) after removal from the freezer.
Quick Thawing: Maintain the product at 33°C to 37oC until use. If the product is removed from original pouch or warmed to 33°C to 37oC it must be used within 12 hours.

 

Do not refrigerate or re-freeze after thawing. Do not microwave.

Inform patients that ARTISS is made from human plasma and discuss the risks and benefits with the patient.

Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased red blood cell turnover. Instruct patients to consult their physician if symptoms of B19 virus infection appear (fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain) [see Pregnancy (8.1)].

Manufactured For Baxter Healthcare Corporation

Deerfield, IL 60015 USA

US License No. 140

Baxter, Artiss, Duploject, Easyspray and Tisseel are trademarks of Baxter International Inc.

2 mL Pouch Label

Fibrin Sealant (Human)
ARTISS 2 mL

NDC 0338-8503-01

Frozen

Baxter Logo

Temperature sensitive – Do NOT expose above 37°C (99°F).

Contents:
Pre-filled syringe containing:
– Sealer Protein Solution ➊: 1 mL, sterile
– Sealer Protein (Human)
– Fibrinolysis Inhibitor (Aprotinin,
Synthetic), 3000 KIU/mL
– Thrombin Solution ➋: 1 mL, sterile
– Thrombin (Human), 4 units/mL
– Calcium Chloride, 40 μmol/mL

TOPICAL USE ONLY
DO NOT INJECT
Read directions for thawing and application before use.
Store at –20°C (–4°F) or colder. Unopened pouches,
thawed at room temperature, may be stored for up to
14 days at 15 – 25°C.
Do not refrigerate, microwave, or re-freeze.
Rx Only
Contents were sterilized and
packaged under aseptic conditions.

Manufactured for Baxter
Healthcare Corporation
Deerfield IL, 60015 USA
U.S. License No. 140
0752634

Lot No.:

Exp. Date:

2 mL Carton Label

0752635

Fibrin Sealant (Human)
ARTISS

TOPICAL USE ONLY

NDC 0338-8503-02

2 mL
Pre-filled Syringe

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Fibrin Sealant (Human)
ARTISS

TOPICAL USE ONLY

2 mL
Pre-filled Syringe

Contents:
Pre-filled syringe containing:

Sealer Protein Solution: 1 mL, sterile

•

Sealer Protein (Human), 86.5 mg/Ml

Vapor Heated, Solvent/Detergent Treated

•

Fibrinolysis Inhibitor (Aprotinin, Synthetic), 30000 KIU/Ml

Thrombin Solution: 1Ml, sterile

•

Thrombin (Human), 4 units/Ml

Vapor Heated, Solvent/Detergent Treated

•

Calcium Chloride, 40 µmol/Ml

TOPICAL USE ONLY
DO NOT INJECT

Do not use on individuals with a known hypersensitivity to aprotinin
and/or any of the active substances or excipients.

The risks and benefits of this product should be discussed with the
patient.

Read full prescribing information before use.

Store at –20°C (–4°F) or colder.

Unopened pouches, thawed at room temperature, may be stored for
up to 14 days at 15 – 25°C.

Do not refrigerate, microwave, or re-freeze.

For single use only

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Fibrin Sealant (Human)
ARTISS

TOPICAL USE ONLY

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Fibrin Sealant (Human)
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Fibrin Sealant (Human)
ARTISS

TOPICAL USE ONLY

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Pre-filled Syringe

2 Ml
Pre-filled Syringe

NDC 0338-8503-02

Fibrin Sealant (Human)
ARTISS

TOPICAL USE ONLY

2 Ml
Pre-filled Syringe

Vapor Heated, Solvent/Detergent Treated, Frozen

TOPICAL USE ONLY
DO NOT INJECT

Manufactured for Baxter Healthcare Corporation
Deerfield, IL 60015 USA
1-888-229-0001

U.S. License No. 140
Made in Austria

Reorder Number: 1501651

Baxter and Artiss are trademarks of Baxter
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DUO Set A 2 ml / 4 ml

Indications for Use:
For the application of ARTISS Fibrin Sealant

For single use only. Not made with natural rubber latex.
Do not reuse or resterilize. Sterilized by gamma radiation.
Sterile and non-pyrogenic in unopened and undamaged package.
Rx Only.

Manufactured for:
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015 USA

Made in Belgium

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REF

BE-90-01-042

Pouch Label

Fibrin Sealant (Human)
ARTISS 2 mL
NDC 0338-9637-01
Frozen

Baxter Logo

Temperature sensitive – Do NOT expose above 37°C (99°F).

Contents:

Pre-filled syringe containing:
– Sealer Protein Solution ➊: 1 mL, sterile
– Fibrinogen (Human), 86.5 mg/mL
– Fibrinolysis Inhibitor (Aprotinin,
Synthetic), 3000 KIU/mL
– Thrombin Solution ➋: 1 mL, sterile
– Thrombin (Human), 4 units/mL
– Calcium Chloride, 40 μmol/mL

TOPICAL USE ONLY
DO NOT INJECT
Read directions for thawing and application before use.
Store at –20°C (–4°F) or colder. Unopened pouches,
thawed at room temperature, may be stored for up to
14 days at 15 – 25°C.
Do not refrigerate, microwave, or re-freeze.
Rx Only
Contents were sterilized and
packaged under aseptic conditions.

Manufactured for Baxter
Healthcare Corporation
Deerfield IL, 60015 USA
U.S. License No. 140
0752951

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DO NOT INJECT

Manufactured for Baxter Healthcare
Corporation
Deerfield, IL 60015 USA
1-888-229-0001

U.S. License No. 140
Made in Austria

Reorder Number: 5500694

Baxter and Artiss are trademarks of Baxter
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Artiss 2 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

Contents:
Pre-filled syringe containing:
Sealer Protein Solution: 1 mL, sterile

•

Fibrinogen (Human), 86.5 mg/mL
Vapor Heated, Solvent/Detergent Treated

•

Fibrinolysis Inhibitor (Aprotinin, Synthetic), 3000 KIU/mL

Thrombin Solution: 1 mL, sterile

•

Thrombin (Human), 4 units/mL
Vapor Heated, Solvent/Detergent Treated

•

Calcium Chloride, 40 μmol/mL

TOPICAL USE ONLY
DO NOT INJECT
Do not use on individuals with a known hypersensitivity
to aprotinin and/or any of the active substances or
excipients.
The risks and benefits of this product should be
discussed with the patient.
Read full prescribing information before use.
Store at –20°C (–4°F) or colder.
Unopened pouches,thawed at room temperature,
may be stored for up to 14 days at 15 – 25°C.
Do not refrigerate, microwave, or re-freeze.
For Single Patient Use Only
No preservative
Not made with natural rubber latex
Rx only

2 mL

Artiss 2 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

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Fibrin Sealant (Human)
ARTISS 4 mL
NDC 0338-9639-01
Frozen

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Temperature sensitive – Do NOT expose above 37°C (99°F).

Contents:

Pre-filled syringe containing:
– Sealer Protein Solution ➊: 2 mL, sterile
– Fibrinogen (Human), 86.5 mg/mL
– Fibrinolysis Inhibitor (Aprotinin,
Synthetic), 3000 KIU/mL
– Thrombin Solution ➋: 2 mL, sterile
– Thrombin (Human), 4 units/mL
– Calcium Chloride, 40 μmol/mL

TOPICAL USE ONLY
DO NOT INJECT
Read directions for thawing and application before use.
Store at –20°C (–4°F) or colder. Unopened pouches,
thawed at room temperature, may be stored for up to
14 days at 15 – 25°C.
Do not refrigerate, microwave, or re-freeze.
Rx Only
Contents were sterilized and
packaged under aseptic conditions.

Manufactured for Baxter
Healthcare Corporation
Deerfield IL, 60015 USA
U.S. License No. 140
0752955

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Artiss 4 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

NDC 0338-9639-01
4 mL

TOPICAL USE ONLY
DO NOT INJECT

Manufactured for Baxter Healthcare
Corporation
Deerfield, IL 60015 USA
1-888-229-0001

U.S. License No. 140
Made in Austria

Reorder Number: 5500695

Baxter and Artiss are trademarks of Baxter
International Inc.

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NDC 0338-9639-01

Artiss 4 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

Contents:
Pre-filled syringe containing:
Sealer Protein Solution: 2 mL, sterile

•

Fibrinogen (Human), 86.5 mg/mL
Vapor Heated, Solvent/Detergent Treated

•

Fibrinolysis Inhibitor (Aprotinin, Synthetic), 3000 KIU/mL

Thrombin Solution: 2 mL, sterile

•

Thrombin (Human), 4 units/mL
Vapor Heated, Solvent/Detergent Treated

•

Calcium Chloride, 40 μmol/mL

TOPICAL USE ONLY
DO NOT INJECT
Do not use on individuals with a known hypersensitivity
to aprotinin and/or any of the active substances or
excipients.
The risks and benefits of this product should be
discussed with the patient.
Read full prescribing information before use.
Store at –20°C (–4°F) or colder.
Unopened pouches,thawed at room temperature,
may be stored for up to 14 days at 15 – 25°C.
Do not refrigerate, microwave, or re-freeze.
For Single Patient Use Only
No preservative
Not made with natural rubber latex
Rx only

4 mL

Artiss 4 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

4 mL

0752956

Artiss 4 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

Barcode

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Pouch Label

Fibrin Sealant (Human)
ARTISS 10 mL
NDC 0338-9641-01
Frozen

Baxter Logo

Temperature sensitive – Do NOT expose above 37°C (99°F).

Contents:

Pre-filled syringe containing:
– Sealer Protein Solution ➊: 5 mL, sterile
– Fibrinogen (Human), 86.5 mg/mL
– Fibrinolysis Inhibitor (Aprotinin,
Synthetic), 3000 KIU/mL
– Thrombin Solution ➋: 5 mL, sterile
– Thrombin (Human), 4 units/mL
– Calcium Chloride, 40 μmol/mL

TOPICAL USE ONLY
DO NOT INJECT
Read directions for thawing and application before use.
Store at –20°C (–4°F) or colder. Unopened pouches,
thawed at room temperature, may be stored for up to
14 days at 15 – 25°C.
Do not refrigerate, microwave, or re-freeze.
Rx Only
Contents were sterilized and
packaged under aseptic conditions.

Manufactured for Baxter
Healthcare Corporation
Deerfield IL, 60015 USA
U.S. License No. 140
0752959

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Artiss 10 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

NDC 0338-9641-01
10 mL

TOPICAL USE ONLY
DO NOT INJECT

Manufactured for Baxter Healthcare
Corporation
Deerfield, IL 60015 USA
1-888-229-0001

U.S. License No. 140
Made in Austria

Reorder Number: 5500696

Baxter and Artiss are trademarks of Baxter
International Inc.

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10 mL

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Artiss 10 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

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10 mL

Baxter Logo

NDC 0338-9641-01

Artiss 10 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

Contents:
Pre-filled syringe containing:
Sealer Protein Solution: 5 mL, sterile

•

Fibrinogen (Human), 86.5 mg/mL
Vapor Heated, Solvent/Detergent Treated

•

Fibrinolysis Inhibitor (Aprotinin, Synthetic),
3000 KIU/mL

Thrombin Solution: 5 mL, sterile

•

Thrombin (Human), 4 units/mL
Vapor Heated, Solvent/Detergent Treated

•

Calcium Chloride, 40 μmol/mL

TOPICAL USE ONLY
DO NOT INJECT
Do not use on individuals with a known hypersensitivity
to aprotinin and/or any of the active substances or
excipients.
The risks and benefits of this product should be
discussed with the patient.
Read full prescribing information before use.
Store at –20°C (–4°F) or colder.
Unopened pouches,thawed at room temperature,
may be stored for up to 14 days at 15 – 25°C.
Do not refrigerate, microwave, or re-freeze.
For Single Patient Use Only
No preservative
Not made with natural rubber latex
Rx only

10 mL

Artiss 10 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

10 mL

0752960

Artiss 10 mL
Fibrin Sealant (Human)
Vapor Heated, Solvent/Detergent Treated, Frozen

Barcode

NDC 0338-9641-01

Baxter Logo

10 mL

Barcode
N3 0338-9641-01 8

Duploject Combi Label

Baxter Logo

DUPLOJECT COMBI

Indication for Use:
For the application of TISSEEL and ARTISS Fibrin Sealant.

REF Symbol

Batch code
Use-by date

For single use only. Not made with natural rubber latex.
Do not reuse or resterilize. Sterilize using ethylene oxide.
Sterile and non-pyrogenic in unopened and undamaged package. Rx Only.

Manufactured for:
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015 USA
1-888-229-0001

Made in Belguim

BE-90-01-057