Samson Medical Technologies, Llc

Samson Medical Technologies, Llc Drugs

• Ceftriaxone
  

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  Ceftriaxone

  

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  Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

  Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of Ceftriaxone.

  THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION WITH STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 mg per mL AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION.

  THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION

  USE THIS FORMULATION OF CEFTRIAXONE ONLY IN PATIENTS WHO REQUIRE A 1 GRAM DOSE.

  2.1 Adult Population

  Ceftriaxone for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

  Ceftriaxone for Injection USP Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of Ceftriaxone.

  Ceftriaxone for Injection should be reconstituted with Sterile Water for Injection, USP to a concentration of 100 mg per mL and further diluted in 50 mL of a compatible solution.

  The recommended adult dosages are outlined in Table 1. Ceftriaxone for Injection, USP, Pharmacy Bulk Package SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

  Ceftriaxone should be administered intravenously (I.V.) over approximately 30 minutes.

  The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

  Table 1: Recommended Dosing Schedule for Ceftriaxone for Injection, USP This formulation of Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of ceftriaxone. * Patients with hepatic impairment and significant renal impairment should not receive more than 2 grams per day of ceftriaxone. Site and Type of Infection Dose Frequency Total Daily Dose Usual Adult Dose 1 gram to 2 grams Once a day or in equally divided doses every 12 hours Should not exceed 4 grams*  Surgical prophylaxis 1 gram I.V. once ½ to 2 hours before surgery Skin and Skin Structure Infections 50 to 75 mg per kg Once a day or in equally divided doses every 12 hours Should not exceed 2 grams Meningitis 100 mg per kg Once a day or in equally divided doses every 12 hours Should not exceed 4 grams*  Serious Infections other than Meningitis 50 to 75 mg per kg Every 12 hours Should not exceed 2 grams 

  2.2 Pediatric Patients

  To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the adult 1 gram dose of ceftriaxone. [see Use in Specific Populations (8.4)]

  2.3 Preparation for Use of Ceftriaxone for Injection, USP, bag SmartPak® Pharmacy Bulk Package

  Ceftriaxone for Injection, USP Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

  Ceftriaxone for Injection USP, Pharmacy Bulk Package SmartPak® bag should not be used in patients who require less than the 1 gram dose of ceftriaxone.

  Directions for Proper Use of a Pharmacy Bulk Package

  NOT FOR DIRECT INFUSION. The Pharmacy Bulk Package is for use in the hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the container closure may be penetrated only one time after reconstitution using a suitable sterile dispensing set or transfer device that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 HOURS from initial reconstitution port closure entry is permitted to complete fluid transfer operations. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. Discard any unused portion after 4 HOURS. This pharmacy bulk package is not intended to be dispensed as a unit PRIOR TO RECONSTITUTION: Visually examine outer (natural foil) bag for damage. IF THE SEAL IS BROKEN OR DAMAGE IS OBSERVED, DO NOT OPEN THE OUTER BAG. STERILITY OF THE INNER BAG SURFACE MAY BE COMPROMISED. DISCARD BOTH BAGS IMMEDIATELY. DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT, IF THE DRY POWDER IS DARK YELLOW OR BROWN, IF THE SEALS ARE NOT INTACT, OR IF THERE IS ANY OTHER DAMAGE TO THE BAG. IN SUCH CASES, DISCARD THE BAG IMMEDIATELY. After initial reconstitution port entry, use entire contents of the Pharmacy Bulk Package promptly. Any unused portion must be discarded after 4 HOURS. Gather the following items prior to the reconstitution of the product: Appropriate number of bags of Sterile Water for Injection and, depending upon the method of filling, appropriate sterile tubing and adapters. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear. Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute Ceftriaxone for Injection SmartPak® Pharmacy Bulk Package or to further dilute a reconstituted solution for intravenous administration. Particulate formation can result.

  INSTRUCTION FOR RECONSTITUTION OF THE PHARMACY BULK PACKAGE BAG SmartPak®

  The entire contents of the bag and the preparation process (reconstitution and dilution) should be completed within 4 hours of initial entry.

  Document the date and time reconstitution starts in the designated place on the container label. The entire contents of the bag must be used within 4 hours from the time of initial entry. Remove the translucent unthreaded cap from the reconstitution (smaller) port and discard it. Reconstitute the powder through the reconstitution (smaller) port, using Sterile Water for Injection according to the Table 2 below: * Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute or further dilute reconstituted ceftriaxone because a precipitate can form. STERILE WATER FOR INJECTION IS THE ONLY RECOMMENDED DILUENT FOR RECONSTITUTION. [see Warnings and Precautions [ (5.2)]. Table 2: Reconstitution Table SmartPak® Bag Size Amount of Sterile Water* Approximate Concentration 100 grams 950 mL 100 mg/mL (1 g/10 mL) After reconstitution is complete, remove the transfer needle from the reconstitution port. Place the bag on a flat surface of a laminar flow hood and mix for at least 15 minutes by rocking gently from side to side. CAUTION: To avoid possible leakage caused by the heavy weight of the added water, do not shake vigorously or pull strongly on the bag. When foam dissipates, visually inspect the bag to verify the solution is clear, colorless to pale yellow and free of particulate matter. DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT. Unscrew the clear threaded cap from the transfer (larger) port and discard it. Attach sterile tubing and filling adapter unit to the transfer port. Reconstituted solution can now be transferred using the transfer port and the filling adapter.

  It should be noted that the spike placed into the transfer port of the Pharmacy Bulk Package SmartPak® is NEVER removed during this procedure and that the reconstitution port is self-sealing.

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