Note the total volume withdrawn into the syringe. Use 60-mL (or larger) syringe with a 20-gauge (or higher) needle to withdraw the reconstituted ANDEXXA solution from each of the vials until the required dosing volume is achieved. Upon reconstitution, the parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration. If dissolution is incomplete, discard the vial, and do not use the product. Typical dissolution time for each vial is approximately three to five minutes. Do not shake (B) shaking could lead to foaming. To ensure dissolution of the cake or powder, gently swirl each vial until complete dissolution of powder occurs (A). To reduce the total reconstitution time needed during preparation, reconstitute all required vials in succession. Slowly inject the SWFI, directing the solution onto the inside wall of the vial to minimize foaming. Use a 20-mL (or larger) syringe and 20-gauge (or higher) needle. Reconstitute the 200 mg vial of ANDEXXA with 20 mL of Sterile Water for Injection (SWFI). Sections or subsections omitted from the full prescribing information are not listed.ĭetermine total number of vials required (see Table 1). FULL PRESCRIBING INFORMATION: CONTENTS * WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS 1 INDICATIONS AND USAGE 2ĝOSAGE AND ADMINISTRATION 2.1ĝose 2.2 Reconstitution 2.3Ědministration 2.4 Restarting Anticoagulant Therapy 3ĝOSAGE FORMS AND STRENGTHS 4ĜONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Thromboembolic and Ischemic Risks 5.2 Re-elevation or Incomplete Reversal of Anti-FXa Activity 6ĚDVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Immunogenicity 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11ĝESCRIPTION 12ĜLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1Ĝarcinogenesis, Mutagenesis, Impairment of Fertility 14ĜLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION
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