expecting [1/10,000):5.3 n.d. >5.7 >5.9 n.d. Vapor Heat Treatment >5.5 >5.6 >5.7 >6.7 1.2 Overall Reduction Factor (ORF) >10.8 >5.6 >11.4 >12.6 3.9 Reduction Factors for Virus Removal and/or Inactivation Thrombin Component Mean Reduction Factors [log 10 ] of Virus Tested Manufacturing Step HIV-1 HAV BVDV PRV MMV Thrombin precursor mass capture 3.2 1.5 1.8 2.5 1.2 Vapor Heat Treatment >5.5 >4.9 >5.3 >6.7 1.0 Solvent/Detergent Treatment >5.3 n.d. >5.5 >6.4 n.d. Ion Exchange Chromatography n.d. n.d. n.d. n.d. 3.6 Overall Reduction Factor (ORF) >14.0 >6.4 >12.6 >15.6 5.8 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. 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. Clinical Studies ARTISS was investigated for adherence of split thickness sheet skin grafts in burn patients in a prospective, randomized, controlled, evaluator- blinded, multicenter clinical study. 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. Of the 138 treated subjects, 94 (68.1%) were male and 44 (31.9%) were female. The mean SD age was 30.8 17.6 years; 19 (13.8%) subjects were less than or equal to 6 years old, 21 (15.2%) subjects were 7 to 18 years old, and 98 (71.0%) were greater than 18 years old. The mean 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 mean SD volume applied was 2.7 1.9 mL (range: 0.2 to 12.0 mL). The mean SD surface area treated was 166.4 95.0 cm 2 (range: 26.1 to 602. cm 2 ). The mean SD calculated dosing volume was 1.8 1.1 mL/100 cm 2 (range: 0.2 to 6.0 mL/100 cm 2 ). 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. Rate of wound closure decreased with increasing age. Wound closure at Day 28 was complete for 72.2% of the 1-6 years old group (N=18) and 31.6% of the 7-18 years old group (N=19) [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. How Supplied/Storage and Handling ARTISS is supplied in the following pack sizes and presentations: Table 4. 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. Patient Counseling Information Because this product is made from human plasma, the physician should discuss the risks and benefits with the patient. Patients should be instructed 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 USE IN SPECIFIC POPULATIONS, Pregnancy (8.1) . Baxter Healthcare Corporation Westlake Village, CA 91362 USA US License No. 140 This product is covered under US Patent Nos. 5,962,405 and 6,579,537. Baxter, Artiss, Easyspray, Fibrinotherm and Duploject are trademarks of Baxter International Inc. Issue Date: 12/2010 Principal Display Panel ARTISS 10 mL kit unit carton NDC 0944-4351-11 10 mL Kit Fibrin Sealant (Human) ARTISS Contents: Sealer Protein Concentrate (Human). Vapor Heated, Solvent/Detergent Treated, freeze dried, sterile, for 5 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 5 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 10 mL sleeve NDC 0944-4351-12 10 mL Kit Fibrin Sealant (Human) ARTISS Contents: Sealer Protein Concentrate (Human). Vapor Heated, Solvent/Detergent Treated, freeze dried, sterile, for 5 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 5 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 5 mL Sealer Protein Concentrate (Human) vial label NDC 0944-7112-05 Sealer Protein Concentrate (Human) Baxter (logo) Vapor Heated, Solvent/Detergent Treated, Freeze-Dried, Sterile Reconstitute with 5 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 Thrombin (Human) vial label NDC 0944-7344-05 Thrombin (Human) Baxter (logo) Vapor Heated, Solvent/Detergent Treated, Freeze-Dried, Sterile Reconstitute with 5 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 2 C to 25 C. Calcium Chloride Solution vial label NDC 0944-7401-05 Calcium Chloride Solution Baxter Sterile For reconstitution of freeze-dried Thrombin (Human), Contents: 5 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 0944-7201-05 Fibrinolysis Inhibitor Solution (Synthetic) Baxter Sterile For reconstitution of freeze-dried Sealer Protein Concentrate (Human), Contents: 5 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 10 mL Frozen unit carton NDC 0944-8503-10 10 mL Fibrin Sealant (Human) ARTISS Frozen TOPICAL USE ONLY DO NOT INJECT Contents: Pre-filled syringe containing: Sealer Protein Solution (1): 5 mL, sterile Sealer Protein (Human) Vapor Heated, Solvent /Detergent Treated Fibrinolysis Inhibitor (Aprotinin, Synthetic), 3000 KIU/mL Thrombin Solution (2): 5 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 10 mL Frozen pouch label NDC 0944-8503-10 Fibrin Sealant (Human) ARTISS 10 mL Frozen Baxter Contents: Pre-filled syringe containing : Sealer Protein Solution (1) : 5 mL, sterile Sealer Protein (Human) Fibrinolysis Inhibitor (Aprotinin, Synthetic), 3000 KIU/mL Thrombin Solution (2) : 5 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 ARTISS 10 mL Syringe label Baxter Fibrin Sealant (Human) ARTISS 10 mL ARTISS FROZEN fibrinogen human thrombin human solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-8503 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FIBRINOGEN (FIBRINOGEN) FIBRINOGEN 90 mg in 1 mL THROMBIN HUMAN (THROMBIN HUMAN) THROMBIN HUMAN 4 [iU] in 1 mL Inactive Ingredients Ingredient Name Strength APROTININ 3000 [iU] in 1 mL CALCIUM CHLORIDE 40 umol in 1 mL ALBUMIN (HUMAN) TRISODIUM CITRATE DIHYDRATE HISTIDINE NIACINAMIDE POLYSORBATE 80 SODIUM CHLORIDE WATER Packaging # Item Code Package Description 1 NDC:0944-8503-10 1 SYRINGE, PLASTIC (SYRINGE) in 1 CARTON 1 10 mL in 1 SYRINGE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125266 01/11/2011 ARTISS fibrinogen human thrombin human kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-4351 Packaging # Item Code Package Description 1 NDC:0944-4351-11 1 KIT (KIT) in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, GLASS 5 mL Part 2 1 VIAL, GLASS 5 mL Part 3 1 VIAL, GLASS 5 mL Part 4 1 VIAL, GLASS 5 mL Part 1 of 4 SEALER PROTEIN CONCENTRATE HUMAN fibrinogen human powder, for solution Product Information Item Code (Source) NDC:0944-7112 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FIBRINOGEN (FIBRINOGEN) FIBRINOGEN 90 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALBUMIN (HUMAN) HISTIDINE NIACINAMIDE POLYSORBATE 80 TRISODIUM CITRATE DIHYDRATE Packaging # Item Code Package Description 1 NDC:0944-7112-05 5 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125266 01/11/2011 Part 2 of 4 THROMBIN HUMAN thrombin human powder, for solution Product Information Item Code (Source) NDC:0944-7344 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THROMBIN HUMAN (THROMBIN HUMAN) THROMBIN HUMAN 4 [iU] in 1 mL Inactive Ingredients Ingredient Name Strength ALBUMIN (HUMAN) SODIUM CHLORIDE Packaging # Item Code Package Description 1 NDC:0944-7344-05 5 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125266 01/11/2011 Part 3 of 4 FIBRINOLYSIS INHIBITOR SOLUTION aprotinin liquid Product Information Item Code (Source) NDC:0944-7201 Route of Administration TOPICAL DEA Schedule Inactive Ingredients Ingredient Name Strength APROTININ 3000 [iU] in 1 mL WATER Packaging # Item Code Package Description 1 NDC:0944-7201-05 5 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125266 01/11/2011 Part 4 of 4 CALCIUM CHLORIDE SOLUTION calcium chloride liquid Product Information Item Code (Source) NDC:0944-7401 Route of Administration TOPICAL DEA Schedule Inactive Ingredients Ingredient Name Strength CALCIUM CHLORIDE 40 umol in 1 mL Packaging # Item Code Package Description 1 NDC:0944-7401-05 5 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125266 01/11/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125266 01/11/2011 Labeler - Baxter Healthcare Corporation (039121363) Establishment Name Address ID/FEI Operations Baxter Innovations GmbH 300178716 MANUFACTURE Revised: 12/2010 Baxter Healthcare Corporation Print this page Add to My Med List More about fibrinogen/thrombin topical Support Group 0 Reviews Add your own review/rating Drug class: miscellaneous coagulation modifiers Professional resources Other brands: TachoSil Related treatment guides Hemostasis]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Miscellaneous coagulation modifiers Related Drugs miscellaneous coagulation modifiers pentoxifylline , Trental , tranexamic acid , Lysteda , Amicar , BeneFix Hemostasis thrombin topical , Recothrom , Artiss , Thrombi-Gel , Thrombinar , Thrombogen , Thrombostat , Evithrom , More... 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