tousled [0.0001).:<0.0001 Comparator (n=60) 20 33% [0.214; 0.453] Hemostasis at 6 min TachoSil (n=59) 56 95% [0.893;1.000] 0.0006 Comparator (n=60) 43 72% [0.603; 0.831] Hepatic A randomized, open-label, parallel group, multi-center trial comparing TachoSil with comparator was conducted to evaluate TachoSil for the secondary treatment of local bleeding in patients undergoing hepatic surgery. A total of 114 patients were randomized to treatment with TachoSil and 110 patients were randomized to treatment with comparator. A similar proportion of male patients and female patients were randomly assigned in the trial (53% and 47%, respectively). The mean (SD) age of patients was 58.1 (13.95) years and in both treatment groups approximately 30% of the patients were above 65 years. The majority of patients were White/Caucasian (80%) and the most common ethnicity was non-Hispanic/non-Latino (88%). A larger proportion of patients in the TachoSil treatment group (81%) than in the comparator treatment group (50%) achieved hemostasis within the first three minutes after treatment application. The primary analysis of the proportion of patients who achieved hemostasis within three minutes showed a statistically significant difference between treatment groups in favor of TachoSil (p> <0.001) and obtained a clinical relevant difference between the two groups defined from the estimated odds ratio (see Table 8). With respect to one of the two secondary endpoints, 108 (95%) patients in the TachoSil group and 84 (76%) patients in the comparator group achieved hemostasis within five minutes in which the secondary analysis also showed a statistically significant difference between the group in favor of TachoSil (p> <0.001, multiplicity adjusted) (see Table 8). * Hochberg's adjustment for multiplicity Hemostatic fleece material made of oxidized cellulose polymer Analyzed by a log rank test for equality over treatments. Patients who did not achieve hemostasis after 10 minutes were censored in the analysis. Table 8. Efficacy Results in Hepatic Surgery, by Treatment, Intent-To-Treat Population Treatment Total number of patients who achieved hemostasis Percentage of patients who achieved hemostasis Odds ratio [95% CI] p-value * Hemostasis at 3 min TachoSil (n=114) 92 81% 4.87 [2.55; 9.29]> <0.001 Comparator (n=110) 55 50% Hemostasis at 5 min TachoSil (n=114) 108 95% 6.24 [2.39;16.30]> <0.001 Comparator (n=110) 84 76% Time to hemostasis - - -> <0.001 TachoSil (n=114) Comparator (n=110) Pediatric In a pediatric subset of a randomized, open-label, parallel group, multi-center trial comparing TachoSil with comparator the efficacy of TachoSil for the secondary treatment of local bleeding in pediatric patients undergoing hepatic surgery was evaluated. In the randomized part of the study, eight patients were treated with TachoSil and nine patients were treated with the comparator. After the randomization phase, an additional 12 patients were treated with TachoSil in a single extension arm to reach 20 patients exposed to TachoSil. A similar proportion of male and female pediatric patients were treated overall in the trial (48% and 52%, respectively). The majority of patients were White/Caucasian (79%) and the most common ethnicity was non-Hispanic/non-Latino (69%). The mean age was slightly higher in the TachoSil group (4.58 years; range 0.4, 13.0 years) than in the comparator group (3.77 years; range 0.4, 16.0 years). A larger proportion of the patients in the TachoSil group (7/8 [88%]) than in the comparator group (4/9 [44%]) achieved hemostasis within three minutes in the randomized part of the study. The results were similar considering the whole set of pediatric patients exposed to TachoSil (17/20 [85%]) (see Table 9) . No statistical testing was performed of the difference between the two groups due to the small sample size. Seven patients in the TachoSil group (88%) and seven patients in the comparator group (78%) achieved hemostasis within five minutes (see Table 9) . * Hemostatic fleece material made of oxidized cellulose polymer Safety analysis set Table 9. Achievement of Hemostasis of Pediatric Patients Undergoing Hepatic Surgery, Intent-To-Treat Population/Safety Population Treatment Total number of achieved hemostasis Percentage of patients Exact [95% CI] Hemostasis at 3 min TachoSil (n=8) 7 88% [47.3, 99.7] Comparator * (n=9) 4 44% [13.7, 78.8] Hemostasis at 5 min TachoSil (n=8) 7 88% [47.3, 99.7] Comparator * (n=9) 7 78% [40.0, 97.2] All TachoSil Patients Hemostasis at 3 min 17 85% [62.1, 96.8] TachoSil (n=20) Hemostasis at 5 min 19 95% [75.1, 99.9] TachoSil (n=20) In another clinical study, 16 pediatric patients were included in a prospective, multi-center, uncontrolled, study where TachoSil was used in connection with resection of the liver with or without segmental liver transplantation. The analysis of the efficacy parameter, time to hemostasis, showed that 13 of 16 patients achieved hemostasis within three minutes after application of TachoSil. One patient obtained hemostasis eight minutes after treatment application and two subjects failed to achieve satisfactory hemostasis within 10 minutes, which necessitated alternative hemostatic measures. The estimated proportion of patients achieving hemostasis within three minutes was 81%, which is considered similar to results seen in the randomized controlled study. How Supplied/Storage and Handling Each TachoSil Patch is packaged individually in a tray with lidding. This is placed in an outer pouch with a desiccant bag and packaged into a folding carton. TachoSil is supplied in the following pack sizes: Package with 1 patch of 3.7 inch x 1.9 inch (9.5 cm x 4.8 cm) (NDC 0338-8701-01) Package with 2 patches of 1.9 inch x 1.9 inch (4.8 cm x 4.8 cm) (NDC 0338-8702-02) Package with 1 patch of 1.2 inch x 1.0 inch (3.0 cm x 2.5 cm) (NDC 0338-8703-01) Package with 5 patches of 1.2 inch x 1.0 inch (3.0 cm x 2.5 cm) (NDC 0338-8703-05) Storage Use TachoSil before expiration date indicated on the package. Store unopened packages of TachoSil between 2ºC and 25ºC. TachoSil does not require refrigeration. Do not freeze. Do not use if package is opened or damaged. Patient Counseling Information Because TachoSil may cause the formation of clots in blood vessels if exposed intravascularly, advise patients to consult their physician if they experience chest pain, shortness of breath or difficulty speaking or swallowing, or leg tenderness or swelling [see Warnings and Precautions (5.1) ] . Instruct patients to consult their physician if symptoms of B19 virus infection appear (fever, drowsiness and chills) followed about two weeks later by a rash and joint pain. Parvovirus B19 most seriously affects pregnant women (fetal infection); immune-compromised individuals or individuals with an increased erythropoiesis (e.g., hemolytic anemia) [see Warnings and Precautions (5.7) ] . Advise patients that, because TachoSil is made from human blood, it may carry a risk of transmitting infectious agents (e.g., viruses), and theoretically, the Creutzfeldt-Jakob (CJD) agent [see Warnings and Precautions (5.7) ] . Distributed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Manufactured by: Takeda Austria GmbH St. Peter Strasse 25 4020 Linz, Austria U.S. License No. 1894 TachoSil is a trademark of Takeda AS registered with the U.S. Patent and Trademark Office. All other trademarks are the property of their respective owners. TAC272 R3 PRINCIPAL DISPLAY PANEL - 1 Patch Blister Pack Pouch Carton - NDC 0338-8701-01 NDC 0338-8701-01 Fibrin Sealant Patch TachoSil 3.7 inch x 1.9 inch (9.5 cm x 4.8 cm) Contents: 1 absorbable fibrin sealant patch Single use only Topical use only Do not use intravascularly Store at 2 C to 25 C (36 F to 77 F) Do not freeze Directions for use: See package insert Do not use if package is opened or damaged Use immediately once the foil pouch is opened Do not resterilize Dispose of any unused product or waste material in accordance with local requirements Rx Only Product Code 1144922 Baxter PRINCIPAL DISPLAY PANEL - 2 Patch Blister Pack Pouch Carton NDC 0338-8702-02 Fibrin Sealant Patch TachoSil 1.9 inch x 1.9 inch (4.8 cm x 4.8 cm) Contents: 2 absorbable fibrin sealant patches Single use only Topical use only Do not use intravascularly Store at 2 C to 25 C (36 F to 77 F) Do not freeze Directions for use: See package insert Do not use if package is opened or damaged Use immediately once the foil pouch is opened Do not resterilize Dispose of any unused product or waste material in accordance with local requirements Rx Only Product Code 1144923 Baxter PRINCIPAL DISPLAY PANEL - 1 Patch Blister Pack Pouch Carton - NDC 0338-8703-01 NDC 0338-8703-01 Fibrin Sealant Patch TachoSil 1.2 inch x 1.0 inch (3.0 cm x 2.5 cm) Contents: 1 absorbable fibrin sealant patch Single use only Topical use only Do not use intravascularly Store at 2 C to 25 C (36 F to 77 F) Do not freeze Directions for use: See package insert Do not use if package is opened or damaged Use immediately once the foil pouch is opened Do not resterilize Dispose of any unused product or waste material in accordance with local requirements Rx Only Product Code 0000000 Baxter TACHOSIL thrombin human and fibrinogen patch Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-8701 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HUMAN THROMBIN (HUMAN THROMBIN) HUMAN THROMBIN 2.0 [USP'U] FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 5.5 mg Inactive Ingredients Ingredient Name Strength EQUINE COLLAGEN ALBUMIN HUMAN RIBOFLAVIN SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM ARGININE HYDROCHLORIDE Product Characteristics Color YELLOW (active side) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0338-8701-01 1 POUCH in 1 CARTON 1 1 BLISTER PACK in 1 POUCH 1 1 PATCH in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125351 04/05/2010 TACHOSIL thrombin human and fibrinogen patch Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-8702 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HUMAN THROMBIN (HUMAN THROMBIN) HUMAN THROMBIN 2.0 [USP'U] FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 5.5 mg Inactive Ingredients Ingredient Name Strength EQUINE COLLAGEN ALBUMIN HUMAN RIBOFLAVIN SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM ARGININE HYDROCHLORIDE Product Characteristics Color YELLOW (active side) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0338-8702-02 2 POUCH in 1 CARTON 1 1 BLISTER PACK in 1 POUCH 1 1 PATCH in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125351 04/05/2010 TACHOSIL thrombin human and fibrinogen patch Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-8703 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HUMAN THROMBIN (HUMAN THROMBIN) HUMAN THROMBIN 2.0 [USP'U] FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 5.5 mg Inactive Ingredients Ingredient Name Strength EQUINE COLLAGEN ALBUMIN HUMAN RIBOFLAVIN SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM ARGININE HYDROCHLORIDE Product Characteristics Color YELLOW (active side) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0338-8703-01 1 POUCH in 1 CARTON 1 1 BLISTER PACK in 1 POUCH 1 1 PATCH in 1 BLISTER PACK 2 NDC:0338-8703-05 5 POUCH in 1 CARTON 2 1 BLISTER PACK in 1 POUCH 2 1 PATCH in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125351 04/05/2010 Labeler - Baxter Healthcare Corporation (005083209) Revised: 09/2017 Baxter Healthcare Corporation Next User Reviews Print this page Add to My Med List More about TachoSil (fibrinogen / thrombin topical) Dosage Information Support Group 0 Reviews Add your own review/rating Drug class: miscellaneous coagulation modifiers 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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