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

71205-679-01
(click image for full-size original)
CEFAZOLIN cefazolin injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-679(NDC:60505-6142)
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cefazolin Sodium (Cefazolin) Cefazolin 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-679-01 1 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (71205-679-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203661 06/30/2017
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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