Artiss
Name: Artiss
What is the most important information I should know about fibrin sealant topical?
You should not be treated with fibrin sealant topical if you are allergic to cows or products made from cows.
What happens if I overdose?
Since this medicine is applied by a healthcare professional in a medical setting, an overdose is unlikely to occur.
Commonly used brand name(s)
In the U.S.
- Artiss
- Tisseel
Available Dosage Forms:
- Solution
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies to evaluate the carcinogenic potential of Artiss or studies to determine the effect of Artiss on fertility have not been performed.
How Supplied/Storage and Handling
Artiss is supplied in the following pack sizes and presentations:
| Pack Size | NDC Number | ||
| Artiss Kit (Freeze-Dried) | Artiss Kit (Freeze-Dried) with DUPLOJECT System | Artiss Pre-Filled Syringe (Frozen) with DUO Set | |
| 2 mL | 0944-4351-03 | 0944-4351-04 | 0944-8503-02 |
| 4 mL | 0944-4351-07 | 0944-4351-08 | 0944-8503-04 |
| 10 mL | 0944-4351-11 | 0944-4351-12 | 0944-8503-10 |
See DOSAGE FORMS AND STRENGTHS, Package Contents (3.2).
Storage
Store Artiss in original carton to protect from light.
Artiss Kit (Freeze-Dried)
Store at 2°C to 25°C. Avoid freezing. After reconstitution, the product must be used within 4 hours. Reconstituted solutions must not be refrigerated or frozen.
Artiss Pre-filled Syringe (Frozen)
| 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 (15-25°C) after removal from the freezer. |
| Quick Thawing: Maintain the product at 33-37°C until use. If the product is removed from original pouch or warmed to 33-37°C it must be used within 12 hours. | |
| Do not refrigerate or re-freeze after thawing. Do not microwave. |
Do not use after the expiration date. Discard if packaging of any components is damaged.
Principal Display Panel
Artiss 4 mL kit unit carton
NDC 0944-4351-07
4 mL
Kit
Fibrin Sealant (Human)
Artiss
Contents:
Sealer Protein Concentrate (Human). Vapor Heated, Solvent/Detergent Treated, freeze dried, sterile, for 2 mL of Sealer Protein Solution
Fibrinolysis Inhibitor Solution (Synthetic), Sterile, 3000 KIU of Aprotinin/mL
Thrombin (Human), Vapor Heated, Solvent/Detergent Treated, freeze dried, sterile, for 2 mL of Thrombin Solution 4 IU/mL
Calcium Chloride Solution. Sterile, 40 µmol/mL
FOR TOPICAL USE ONLY
NOT FOR INJECTION
Do not use on individuals with a know hypersensitivity to aprotinin. The risk and benefits of this product should be discussed with the patient. Read the full prescribing information before use.
For single use only.
No preservative
Latex free
Rx Only
Baxter
Artiss 4 mL kit sleeve
NDC 0944-4351-08
4 mL
Kit
Fibrin Sealant (Human)
Artiss
Contents:
Sealer Protein Concentrate (Human). Vapor Heated, Solvent/Detergent Treated, freeze dried, sterile, for 2 mL of Sealer Protein Solution
Fibrinolysis Inhibitor Solution (Synthetic), Sterile, 3000 KIU of Aprotinin/mL
Thrombin (Human), Vapor Heated, Solvent/Detergent Treated, freeze dried, sterile, for 2 mL of Thrombin Solution 4 IU/mL
Calcium Chloride Solution. Sterile, 40 µmol/mL
Also includes: DUPLOJECT System for Artiss [Fibrin Sealant (Human)] 2mL/4mL
FOR TOPICAL USE ONLY
NOT FOR INJECTION
Do not use on individuals with a know hypersensitivity to aprotinin. The risk and benefits of this product should be discussed with the patient. Read the full prescribing information before use.
For single use only.
No preservative
Latex free
Rx Only
Baxter
Sealer Protein Concentrate (Human) vial label
NDC 0944-7112-02
Sealer Protein Concentrate (Human)
Baxter
Vapor Heated, Solvent/Detergent Treated, Freeze-Dried, Sterile
Reconstitute with 2 mL of Fibrinolysis Inhibitor Solution (Synthetic)
Vial contains a stirrer to facilitate reconstitution.
Baxter Healthcare Corporation
Westlake Village, CA 91362 USA
U.S. License No. 140
Use within 4 hours of reconstitution.
Read enclosed directions prior to use.
NOT FOR INJECTION.
Store at 2ºC to 25ºC.
Rx only
Thrombin (Human) vial label
NDC 0944-7344-02
Thrombin (Human)
Baxter
Vapor Heated, Solvent/Detergent Treated, Freeze-Dried, Sterile
Reconstitute with 2 mL of Calcium Chloride Solution
Concentration: 4 IU/mL
Baxter Healthcare Corporation
Westlake Village, CA 91362 USA
U.S. License No. 140
Rx Only
Use within 4 hours of reconstitution.
Read enclosed directions prior to use.
NOT FOR INJECTION.
Store at 2ºC to 25ºC.
Calcium Chloride Solution vial label
NDC 0944-7401-02
Calcium Chloride Solution
Baxter
Sterile For reconstitution of freeze-dried Thrombin (Human), Contents: 2 mL
Concentration: 40 µmol/mL
NOT FOR INJECTION. Store at 2°C to 25°C.
Baxter Healthcare Corporation
Westlake Village, CA 91362 USA
U.S. License No. 140
Rx Only
Fibrinolysis Inhibitor Solution (Synthetic) vial label
NDC 0944-7201-01
Fibrinolysis Inhibitor Solution (Synthetic)
Baxter
Sterile For reconstitution of freeze-dried Sealer Protein Concentrate (Human), Contents: 1 mL
Concentration: 3000 KIU of Aprotinin/mL
NOT FOR INJECTION. Store at 2°C to 25°C.
Baxter Healthcare Corporation
Westlake Village, CA 91362 USA
U.S. License No. 140
Rx Only
Artiss Frozen 4 mL unit carton
NDC 0944-8503-04
4 mL
Fibrin Sealant (Human)
Artiss
Frozen
TOPICAL USE ONLY
DO NOT INJECT
Contents:
Pre-filled syringe containing:
Sealer Protein Solution (1): 2 mL, sterile
Sealer Protein (Human) Vapor Heated, Solvent /Detergent Treated
Fibrinolysis Inhibitor (Aprotinin, Synthetic), 3000 KIU/mL
Thrombin Solution (2): 2 mL, sterile
Thrombin (Human), 4 units/mL Vapor Heated, Solvent /Detergent Treated
Calcium Chloride, 40 µmol/mL
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.
The product must be used within 12 hours after warming to 33-37°C or removal form original pouches.
Do not refrigerate, microwave, or re-freeze.
For single use only
No preservative
Latex free
Rx Only
Contents were sterilized and package under aseptic conditions.
Artiss Frozen 4 mL pouch label
NDC 0944-8503-04
Fibrin Sealant (Human)
Artiss 4 mL
Frozen
Baxter
Contents:
Pre-filled syringe containing:
Sealer Protein Solution (1): 2 mL, sterile
Sealer Protein (Human)
Fibrinolysis Inhibitor (Aprotinin, Synthetic), 3000 KIU/mL
Thrombin Solution (2): 2 mL, sterile
Thrombin (Human), 4 units/mL
Calcium Chloride, 40 µmol/mL
Read directions for thawing and application before use.
TOPICAL USE ONLY
DO NOT INJECT
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 package under aseptic conditions.
Baxter Healthcare Corporation
Westlake Village, CA 91362 USA
U.S. License No. 140
Rx Only
Artiss 4 mL Syringe label
Baxter
Fibrin Sealant (Human)
Artiss
4 mL
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| Artiss FROZEN fibrinogen human thrombin human solution | ||||||||||||||||||||||
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| Labeler - Baxter Healthcare Corporation (039121363) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Baxter Innovations GmbH | 300178716 | MANUFACTURE | |
Liver Dose Adjustments
Data not available
Dialysis
Data not available
Other Comments
To prevent fibrin sealant topical from adhering to gloves and instruments, wet with saline before contact with product.
Fibrin sealant topical Breastfeeding Warnings
There are no data on the excretion of fibrin sealant topical into human milk. Because many drugs are excreted in human milk, caution is recommended when fibrin sealant topical is administered to a lactating woman.