RX ITEM-Artiss 4ml Syg 4ml by ASD Healthcare

ARTISS [Fibrin Sealant], Vapor Heated, Solvent Detergent Treated, (ARTISS) is two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein (Human) and Thrombin (Human), mimic the final stage of the blood coagulation cascade.
Sealer Protein (Human) is sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as freeze-dried powder [Sealer Protein Concentrate (Human)] for reconstitution with Fibrinolysis Inhibitor Solution (Synthetic) or as frozen liquid solution pre-filled into one side of dual-chambered syringe . The active ingredient in Sealer Protein (Human) is fibrinogen. 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) is sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as freeze-dried powder for reconstitution with Calcium Chloride Solution or as frozen liquid solution pre-filled into one side of dual-chambered syringe

Mechanism of Action
Upon mixing Sealer Protein (Human) and Thrombin (Human), soluble fibrinogen is transformed into fibrin that adheres to the wound surface and to the skin graft to be affixed. Due to the low thrombin concentration, polymerization of ARTISS will take approximately 60 second
INDICATIONS AND USAGE
ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to year of age.
ARTISS is not indicated for hemostasis.
2 DOSAGE AND ADMINISTRATION
FOR TOPICAL USE ONLY DO NOT INJECT.
The required dose of ARTISS depends on the size of the surface to be covered. The approximate surface areas covered by each package size of ARTISS are:
Approximate area requiring skin graft fixation
Required package size of ARTISS
100 cm2
2 mL
200 cm2
4 mL
500 cm2
10 mL
It is recommended that every time patient receives dose of ARTISS the name and lot number (batch number) of the product are documented in order to maintain record of the batches used.
2.1 Preparation of ARTISS Kit (Freeze-Dried)
During preparation of ARTISS Kit:
DO NOT EXPOSE TO TEMPERATURES ABOVE 37?C DO NOT REFRIGERATE OR FREEZE AFTER RECONSTITUTION
Do not use iodine or heavy metal containing preparations such as betadine for disinfection of vial stoppers. Allow alcohol-based disinfectants to evaporate before puncturing stopper.
After reconstitution, the product must be used within hours.
Use separate syringes for reconstituting Sealer Protein and Thrombin solutions and for application to prevent premature clotting.
ARTISS Kit contains the following substances in four separate vials:
-Sealer Protein Concentrate (Human)
-Fibrinolysis Inhibitor Solution (Synthetic)
-Thrombin (Human)
-Calcium Chloride Solution
Freeze-dried Sealer Protein Concentrate and Thrombin are reconstituted in Fibrinolysis Inhibitor Solution and Calcium Chloride Solution, respectively. The Sealer Protein Solution and Thrombin Solution are then combined using the DUPLOJECT Preparation and Application System, or an equivalent delivery device cleared by FDA for use with ARTISS to form the Fibrin Sealant.
Prewarming ARTISS Kit with FIBRINOTHERM
If FIBRINOTHERM device is not available, contact Baxter (1-800-423-2090) for assistance
DOSAGE FORMS AND STRENGTHS
3.1 Presentations and Pack Sizes
ARTISS Kit (Freeze-Dried) is supplied as mL, mL and 10 mL (total volume) pack sizes with and without the DUPLOJECT Preparation and Application System.
ARTISS Pre-filled Syringe (Frozen) is supplied as mL, mL and 10 mL (total volume) pack sizes with the DUO Set.
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 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.

Artiss 4ml Syg 4ml by ASD Healthcare
NDC No.94485-0304- UPC/GTIN No. MPN 40549 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Rese

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THROMBIN/FIBRINOG/APROT/C
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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