Cefazolin (Page 3 of 3)

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.

When reconstituted or diluted according to the instructions below, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

Single-Dose Vials: For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL. Discard unused portion.

Vial Size	Amount of Diluent	Approximate Concentration	Approximate Available Volume
500 mg	2 mL	225 mg/mL	2.2 mL
1 gram	2.5 mL	330 mg/mL	3 mL

Pharmacy Bulk Vials: Add Sterile Water for Injection, Bacteriostatic Water for Injection or Sodium Chloride Injection according to the table below. SHAKE WELL. Use promptly. (Discard vial within 4 hours after initial entry.)

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

ADMINISTRATION

Intramuscular Administration: Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.

Intravenous Administration: Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

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

HOW SUPPLIED

Cefazolin for Injection, USP, containing cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin, is supplied as follows:

NDC	Cefazolin for Injection, USP	Package Factor
25021-100-10	Cefazolin sodium equivalent to	25 vials per carton
	500 mg cefazolin single-dose vial
25021-101-10	Cefazolin sodium equivalent to	25 vials per carton
	1 gram cefazolin single-dose vial

Cefazolin for Injection, USP is also available in a 10 gram Pharmacy Bulk Package. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin and is supplied as follows:

NDC	Cefazolin for Injection, USP	Package Factor
25021-102-99	Cefazolin sodium equivalent	10 Pharmacy Bulk
	to 10 grams of cefazolin	Packages per carton

As with other cephalosporins, Cefazolin for Injection, USP tends to darken depending on storage conditions, within the stated recommendations, however, product potency is not adversely affected.

Storage Conditions

Before reconstitution, store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Brands listed are the trademarks of their respective owners.

SAGENT^®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Italy©2020 Sagent Pharmaceuticals, Inc.

Revised: July 2020

SAGENT Pharmaceuticals^®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-100-10

Rx only

CEFAZOLIN for Injection, USP

500 mg per vial

Each vial contains cefazolin sodium equivalent to 500 mg cefazolin

For Intravenous or Intramuscular Use

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-101-10

Rx only

CEFAZOLIN for Injection, USP

1 gram per vial

Each vial contains cefazolin sodium equivalent to 1 gram cefazolin

For Intravenous or Intramuscular Use

CEFAZOLIN cefazolin sodium injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-100 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cefazolin sodium (cefazolin) cefazolin 500 mg in 2.2 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-100-10 25 VIAL in 1 CARTON contains a VIAL 1 2.2 mL in 1 VIAL This package is contained within the CARTON (25021-100-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065303 02/01/2009

CEFAZOLIN cefazolin sodium injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-101 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cefazolin sodium (cefazolin) cefazolin 1 g in 3 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-101-10 25 VIAL in 1 CARTON contains a VIAL 1 3 mL in 1 VIAL This package is contained within the CARTON (25021-101-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065303 02/01/2009

Labeler — Sagent Pharmaceuticals (796852890)

Revised: 05/2021 Sagent Pharmaceuticals