Tranexamic Acid
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Questions & Answers
Side Effects & Adverse Reactions
Focal areas of retinal degeneration have developed in cats, dogs, and rats following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40 times the recommended usual human dose) from 6 days to 1 year. The incidence of such lesions has varied from 25% to 100% of animals treated and was dose-related. At lower doses, some lesions have appeared to be reversible.
Limited data in cats and rabbits showed retinal changes in some animals with doses as low as 126 mg/kg/day (only about 3 times the recommended human dose) administered for several days to two weeks.
No retinal changes have been reported or noted in eye examinations in patients treated with tranexamic acid for weeks to months in clinical trials.
However, visual abnormalities, often poorly characterized, represent the most frequently reported postmarketing adverse reaction in Sweden. For patients who are to be treated continually for longer than several days, an ophthalmological examination, including visual acuity, color vision, eye-ground, and visual fields, is advised, before commencing and at regular intervals during the course of treatment. Tranexamic acid should be discontinued if changes in examination results are found.
Convulsions have been reported in association with tranexamic acid treatment, particularly in patients receiving tranexamic acid during cardiovascular surgery and in patients inadvertently given tranexamic acid into the neuraxial system.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Tranexamic acid injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
History
There is currently no drug history available for this drug.
Other Information
Each mL of the sterile solution for intravenous injection contains 100 mg Tranexamic Acid, USP and Water for Injection, USP to 1 mL.FORMULATION
Chemical Name: trans-4-(aminomethyl) cyclohexanecarboxylic acid
Structural Formula:
Molecular Formula: C8H15NO2 Molecular Weight: 157.2
Tranexamic Acid, USP is a white crystalline powder. The aqueous solution for injection has a pH of 6.5 to 8.0.
Sources
Tranexamic Acid Manufacturers
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Heritage Pharmaceuticals Inc.
![Tranexamic Acid Injection, Solution [Heritage Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tranexamic Acid | Heritage Pharmaceuticals Inc.
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of tranexamic acid injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (μmol/L)
120 to 250 (1.36 to 2.83 mg/dL)
250 to 500 (2.83 to 5.66 mg/dL)
>500 (>5.66 mg/dL)
Tranexamic Acid I.V. Dosage
10 mg/kg BID
10 mg/kg daily
10 mg/kg every 48 hours
or
5 mg/kg every 24 hours
For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
-
American Health Packaging
Tranexamic Acid | American Health Packaging
2.1 Recommended DosageThe recommended dose of tranexamic acid tablets for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic acid tablets may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.
2.2 Renal ImpairmentIn patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of Tranexamic Acid Tablets in Patients with Renal ImpairmentTranexamic Acid Tablets
Serum Creatinine
(mg/dL)Adjusted Dose
Total Daily Dose
Cr above 1.4 and
≤ 2.81300 mg (two 650 mg tablets)
two times a day for a maximum of
5 days during menstruation2600 mg
Cr above 2.8 and
≤ 5.71300 mg (two 650 mg tablets)
once a day for a maximum of
5 days during menstruation1300 mg
Cr above 5.7
650 mg (one 650 mg tablet)
once a day for a maximum of
5 days during menstruation650 mg
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Akorn, Inc.
Tranexamic Acid | Boryung Pharmaceutical Co., Ltd
oral use only
-
Nexus Pharmaceuticals Inc
Tranexamic Acid | Nexus Pharmaceuticals Inc
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of tranexamic acid intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (µmol/L) Tranexamic Acid I.V. Dosage 120 to 250 (1.36 to 2.83 mg/dL) 10 mg/kg BID 250 to 500 (2.83 to 5.66 mg/dL) 10 mg/kg daily >500 (>5.66 mg/dL) 10 mg/kg every 48 hours
or
5 mg/kg every 24 hoursFor intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
-
App Pharmaceuticals, Llc
Tranexamic Acid | Mckesson
• take only one dose per day (24 hours) – see Overdose warning adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use Other information • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F) • protect from light -
Prasco Laboratories
Tranexamic Acid | Prasco Laboratories
2.1 Recommended DosageThe recommended dose of Tranexamic Acid Tablets for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic Acid Tablets may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.
2.2 Renal ImpairmentIn patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of TRANEXAMIC ACID TABLETS in Patients with Renal Impairment Tranexamic Acid Tablets Serum Creatinine
(mg/dL) Adjusted Dose Total Daily Dose Cr above 1.4 and ≤ 2.8 1300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation 2600 mg Cr above 2.8 and ≤ 5.7 1300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation 1300 mg Cr above 5.7 650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation 650 mg -
Watson Laboratories, Inc.
Tranexamic Acid | Actavis Pharma, Inc.
2.1 Recommended DosageThe recommended dose of tranexamic acid tablets for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic acid tablets may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.
2.2 Renal ImpairmentIn patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of Tranexamic Acid Tablets in Patients with Renal Impairment Tranexamic Acid Tablets Serum Creatinine
(mg/dL) Adjusted Dose Total Daily Dose Cr above 1.4 and
≤ 2.8 1300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation 2600 mg Cr above 2.8 and
≤ 5.7 1300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation 1300 mg Cr above 5.7 650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation 650 mg -
Mylan Institutional Llc
Tranexamic Acid | Mylan Institutional Llc
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of tranexamic acid injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight 3 to 4 times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (µmol/L) Tranexamic Acid I.V. Dosage120 to 250 (1.36 to 2.83 mg/dL)
10 mg/kg BID
250 to 500 (2.83 to 5.66 mg/dL)
10 mg/kg daily
> 500 (> 5.66 mg/dL)
10 mg/kg every 48 hours
or
5 mg/kg every 24 hoursFor intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
-
Fresenius Kabi Usa, Llc
Tranexamic Acid | Great Lakes Wholesale, Marketing, & Sales, Inc.
drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor -
X-gen Pharmaceuticals, Inc.
Tranexamic Acid | X-gen Pharmaceuticals, Inc.
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of tranexamic acid intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intraveneous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (μmol/L)
Tranexamic Acid I.V. Dosage
120 to 250 (1.36 to 2.83 mg/dL)
10 mg/kg BID
250 to 500 (2.83 to 5.66 mg/dL)
10 mg/kg daily
>500 (>5.66 mg/dL)
10 mg/kg every 48 hours or 5 mg/kg every 24 hours
For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
-
Prasco Laboratories
Tranexamic Acid | Prasco Laboratories
2.1 Recommended DosageThe recommended dose of Tranexamic Acid Tablets for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic Acid Tablets may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.
2.2 Renal ImpairmentIn patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of TRANEXAMIC ACID TABLETS in Patients with Renal Impairment Tranexamic Acid Tablets Serum Creatinine
(mg/dL) Adjusted Dose Total Daily Dose Cr above 1.4 and ≤ 2.8 1300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation 2600 mg Cr above 2.8 and ≤ 5.7 1300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation 1300 mg Cr above 5.7 650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation 650 mg -
Apotex Corp.
Tranexamic Acid | Apotex Corp.
2.1 Recommended DosageThe recommended dose of tranexamic acid for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic acid tablets may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.
2.2 Renal ImpairmentIn patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of Tranexamic acid in Patients with Renal Impairment Tranexamic acid Serum Creatinine
(mg/dL) Adjusted Dose Total Daily Dose Cr above 1.4 and
≤ 2.8 1300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation 2600 mg Cr above 2.8 and
≤ 5.7 1300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation 1300 mg Cr above 5.7 650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation 650 mg -
Acella Pharmaceuticals
Tranexamic Acid | Acella Pharmaceuticals
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of Tranexamic Acid Injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
For intravenous infusion, Tranexamic Acid Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to Tranexamic Acid Injection. Tranexamic Acid Injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
-
X-gen Pharmaceuticals, Inc.
Tranexamic Acid | X-gen Pharmaceuticals, Inc.
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of tranexamic acid intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intraveneous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (μmol/L)
Tranexamic Acid I.V. Dosage
120 to 250 (1.36 to 2.83 mg/dL)
10 mg/kg BID
250 to 500 (2.83 to 5.66 mg/dL)
10 mg/kg daily
>500 (>5.66 mg/dL)
10 mg/kg every 48 hours or 5 mg/kg every 24 hours
For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
-
American Regent, Inc.
Tranexamic Acid | American Regent, Inc.
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of tranexamic acid injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (μmol/L) Tranexamic Acid I.V. Dosage 120 to 250 (1.36 to 2.83 mg/dL) 10 mg/kg BID 250 to 500 (2.83 to 5.66 mg/dL) 10 mg/kg daily >500 (>5.66 mg/dL) 10 mg/kg every 48 hours
or
5 mg/kg every 24 hoursFor intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
-
Heritage Pharmaceuticals Inc.
Tranexamic Acid | Heritage Pharmaceuticals Inc.
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of tranexamic acid injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (μmol/L)
120 to 250 (1.36 to 2.83 mg/dL)
250 to 500 (2.83 to 5.66 mg/dL)
>500 (>5.66 mg/dL)
Tranexamic Acid I.V. Dosage
10 mg/kg BID
10 mg/kg daily
10 mg/kg every 48 hours
or
5 mg/kg every 24 hoursFor intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
-
Golden State Medical Supply, Inc.
Tranexamic Acid | Golden State Medical Supply, Inc.
2.1 Recommended DosageThe recommended dose of tranexamic acid for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic acid tablets may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.
2.2 Renal ImpairmentIn patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of Tranexamic acid in Patients with Renal Impairment Tranexamic acid Serum Creatinine
(mg/dL) Adjusted Dose Total Daily DoseCr above 1.4 and
≤ 2.81300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation
2600 mg
Cr above 2.8 and
≤ 5.71300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation
1300 mg
Cr above 5.7
650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation
650 mg
![Tranexamic Acid Tablet, Film Coated [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3c47059e-50d9-4e40-910e-67d199458b5e&name=image-01.jpg)
![Tranexamic Acid Injection, Solution [Akorn, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dfbc0316-eb05-47aa-899b-d0c6debe0515&name=label.jpg)
![Tranexamic Acid Injection, Solution [Nexus Pharmaceuticals Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dbfb0fdd-e5cc-4d54-a998-3b8fd63ed45c&name=tranexamic-acid-injection-figure-2-TA_Injection_PDP_Updated.jpg)
![Tranexamic Acid Injection, Solution [App Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d6679628-990d-47d3-857e-d87c2a6cd860&name=7b43b1c6-8915-4086-879e-3b45f746806c-01.jpg)
![Tranexamic Acid Tablet [Prasco Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=add851b1-0f2d-46e9-b122-f4f5ff216539&name=tranexamic-03.jpg)
![Tranexamic Acid Tablet, Film Coated [Watson Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3f07e93b-3568-487e-894f-8f90e5a0960a&name=tranexamic-acid-tablets-3.jpg)
![Tranexamic Acid Injection, Solution [Mylan Institutional Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6f033f1e-8c78-4c87-b870-6493944315ff&name=9d2a06da-dea1-439e-97a3-41067cb102ef-02.jpg)
![Tranexamic Acid Injection, Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=db484862-8c8d-4344-a9bd-71a290fa97dc&name=healthcare-44-227-1.jpg)
![Tranexamic Acid Injection, Solution [X-gen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1553f7eb-d5a8-4274-9762-5bcc5ffcf809&name=tranexamic-acid-2.jpg)
![Tranexamic Acid Tablet [Prasco Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=03003067-1bbc-4f5b-85ec-c21a955fbc06&name=tranexamic-03.jpg)
![Tranexamic Acid Tablet [Apotex Corp.]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Tranexamic Acid Injection, Solution [Acella Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e8a45862-2187-49eb-892e-ade1b0cde938&name=cartonlabel.jpg)
![Tranexamic Acid Injection, Solution [X-gen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e6abc22f-4fac-4e7e-98e6-8f25b0f04420&name=tranexamic-acid-injection-2.jpg)
![Tranexamic Acid Injection, Solution [American Regent, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=81916afc-f83a-4bba-a810-17393980e27e&name=transexamic-acid-injection-2.jpg)
![Tranexamic Acid Injection, Solution [Heritage Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=28ccedba-99cd-49f3-a782-798df5258524&name=tranexamic-2b.jpg)
![Tranexamic Acid Tablet [Golden State Medical Supply, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0369e77d-94da-488f-bc9b-e9a68bc13da3&name=Label_Graphic-650mg-30s.jpg)
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