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, USP 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.
Vial size | Amount ofDiluent | ApproximateConcentration | ApproximateAvailable Volume |
1 gram | 2.5 mL | 330 mg/mL | 3.0 mL |
2 grams | 5 mL | 330 mg/mL | 6.0 mL |
ADMINISTRATION
Intramuscular Administration: Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection, USP should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection, USP.
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, USP in 50 to 100 mL of 1 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
Each vial of Cefazolin for Injection, USP contains cefazolin sodium equivalent to 1 gram cefazolin.
NDC 71205-679-01, 1 gram, box of 1 vial
As with other cephalosporins, cefazolin tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.
Before reconstitution protect from light and store at 20° to 25° C (68° to 77°F) [See USP Controlled Room Temperature].
CLINITEST is a registered trademark of Miles, Inc.
CLINISTIX is a registered trademark of Bayer Corporation.
Manufactured by:
Qilu Pharmaceutical Co., Ltd.
High Tech Zone
Jinan, 250101, China
Manufactured for:
Apotex Corp.
Weston, Florida, USA 33326
Relabeled by:
Proficient Rx LPThousand Oaks, CA 91320
Code number: 34040001011F
Rev 01/22
1 g Vial Label
NDC 71205-679-01
Cefazolin for Injection, USP
1 gram/vial
For IM or IV Use
Rx Only
CEFAZOLIN cefazolin injection, powder, for solution | |||||||||||||||||
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Labeler — Proficient Rx LP (079196022) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Proficient Rx LP | 079196022 | RELABEL (71205-679) |
Revised: 08/2022 Proficient Rx LP
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