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  Burberry Burberry Cashmere Long-lasting Flawless Soft-matte Foundation Sunscreen Broad Spectrum Spf 20 Deep Brown No.66 | Sagent Pharmaceuticals

  

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  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection should be administered intravenously (IV) over approximately 30 minutes.

  After constitution, cefazolin can be administered by parenteral administration. However, the intent of this pharmacy bulk package is for the preparation of the solutions for intravenous infusion only.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours 2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram IV administered ½ hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment Creatinine Clearance Dose Frequency 55 mL/min. or greater full dose normal frequency 35 to 54 mL/min. full dose every 8 hours or longer 11 to 34 mL/min. 1/2 usual dose every 12 hours 10 mL/min. or less 1/2 usual dose every 18 to 24 hours 2.4 Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  2.5 Preparation for Use of Cefazolin for Injection

  Reconstitution

  Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  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 closure may be penetrated only one time using a suitable sterile dispensing set that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry, use entire contents of Pharmacy Bulk Package promptly. The entire contents of the Pharmacy Bulk Package should be dispensed within 4 hours of initial entry. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. Discard Pharmacy Bulk Package within 4 hours after initial entry.

  Pharmacy Bulk Packages

  Add Sterile Water for Injection, Bacteriostatic Water for Injection or Sodium Chloride Injection according to the table below. SHAKE WELL.

  Pharmacy Bulk
  Package Size Amount of Diluent Approximate
  Concentration Approximate
  Available Volume 10 grams 45 mL 1 gram/5 mL 51 mL 10 grams 96 mL 1 gram/10 mL 102 mL

  Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

    Sodium Chloride Injection, USP   5% or 10% Dextrose Injection, USP   5% Dextrose in Lactated Ringer's Injection, USP   5% Dextrose and 0.9% Sodium Chloride Injection, USP   5% Dextrose and 0.45% Sodium Chloride Injection, USP   5% Dextrose and 0.2% Sodium Chloride Injection, USP   Lactated Ringer's Injection, USP   Invert Sugar 5% or 10% in Sterile Water for Injection   Ringer's Injection, USP   5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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