Cefazolin

Baxter Healthcare Corporation

Cefazolin Injection, USP in GALAXY Container(PL 2040 Plastic)

FULL PRESCRIBING INFORMATION: CONTENTS*

• CEFAZOLIN DESCRIPTION
• CLINICAL PHARMACOLOGY
  • Microbiology
• CEFAZOLIN INDICATIONS AND USAGE
  • Respiratory Tract Infections:
  • Urinary Tract Infections:
  • Skin and Skin Structure Infections:
  • Biliary Tract Infections:
  • Bone and Joint Infections:
  • Genital Infections:
  • Septicemia:
  • Endocarditis:
  • Perioperative Prophylaxis:
• CEFAZOLIN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Information for Patients
  • Drug Interactions
  • Drug/Laboratory Test Interactions
  • Carcinogenesis/Mutagenesis
  • Pregnancy
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use
• CEFAZOLIN ADVERSE REACTIONS
  • Gastrointestinal
  • Allergic
  • Hematologic
  • Hepatic
  • Renal
  • Local Reactions
  • Other Reactions
• CEFAZOLIN DOSAGE AND ADMINISTRATION
  • Perioperative Prophylactic Use
  • Dosage Adjustment for Patients With Reduced Renal Function
• DIRECTIONS FOR USE OF CEFAZOLIN INJECTION, USP IN GALAXY CONTAINER (PL 2040 PLASTIC)
  • Storage
  • Thawing of Plastic Container
  • Preparation for administration:
• HOW SUPPLIED
• STORAGE AND HANDLING
• REFERENCES
• PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin Injection, USP and other antibacterial drugs, Cefazolin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

CEFAZOLIN DESCRIPTION

Cefazolin Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.

Structural Formula:

The sodium content is 46 mg per gram of cefazolin.

Dextrose Hydrous, USP structural (molecular) formula:

The molecular weight of Dextrose Hydrous, USP is 198.17.

The chemical name is D-Glucose, Monohydrate.

Cefazolin Injection, USP is a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL solution containing cefazolin sodium equivalent to 1 g of Cefazolin, USP. Dextrose, USP has been added to adjust osmolality (2 g as dextrose hydrous).

The pH of Cefazolin Injection, USP has been adjusted with sodium bicarbonate. The solution is intended for intravenous use after thawing to room temperature.

This GALAXY container (PL 2040 Plastic) is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. However, the suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

Studies have shown that following intravenous administration of cefazolin to normal volunteers, mean serum concentrations peaked at approximately 185 mcg/mL and were approximately 4 mcg/mL at 8 hours for a 1-gram dose.

The serum half-life for cefazolin is approximately 1.8 hours following IV administration.

In a study (using normal volunteers) of constant intravenous infusion with dosages of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours (approximately 100 mg), cefazolin produced a steady serum level at the third hour of approximately 28 mcg/mL.

Studies in patients hospitalized with infections indicate that cefazolin produces mean peak serum levels approximately equivalent to those seen in normal volunteers.

Bile levels in patients without obstructive biliary disease can reach or exceed serum levels by up to 5 times; however, in patients with obstructive biliary disease, bile levels of cefazolin are considerably lower than serum levels (<1.0 mcg/mL).

In synovial fluid, the level of cefazolin becomes comparable to that reached in serum at about 4 hours after drug administration.

Studies of cord blood show prompt transfer of cefazolin across the placenta. Cefazolin is present in very low concentrations in the milk of nursing mothers.

Cefazolin is excreted unchanged in the urine. In the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours.

In patients undergoing peritoneal dialysis (2 L/hr.), cefazolin produced mean serum levels of approximately 10 and 30 mcg/mL after 24 hours instillation of a dialyzing solution containing 50 mg/L and 150 mg/L, respectively. Mean peak levels were 29 mcg/mL (range 13 to 44 mcg/mL) with 50 mg/L (3 patients), and 72 mcg/mL (range 26 to 142 mcg/mL) with 150 mg/L (6 patients). Intraperitoneal administration of cefazolin is usually well tolerated.

Controlled studies on adult normal volunteers, receiving 1 gram 4 times a day for 10 days, monitoring CBC, SGOT, SGPT, bilirubin, alkaline phosphatase, BUN, creatinine, and urinalysis, indicated no clinically significant changes attributed to cefazolin.

Microbiology

In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell wall synthesis. Cefazolin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in INDICATIONS AND USAGE.

Gram-Positive Aerobes

Staphylococcus aureus (including β-lactamase-producing strains)

Staphylococcus epidermidis

Streptococcus pyogenes, Streptococcus agalactiae, and other strains of streptococci

Streptococcus pneumoniae

Methicillin-resistant staphylococci are uniformly resistant to cefazolin, and many strains of enterococci are resistant.

Gram-Negative Aerobes

Escherichia coli

Proteus mirabilis

Most strains of indole positive Proteus (Proteus vulgaris), Enterobacter spp., Morganella morganii, Providencia rettgeri, Serratia spp., and Pseudomonas spp. are resistant to cefazolin.

Susceptibility Tests

Diffusion Techniques

Quantitative methods that require measurement of zone diameters provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure1 that has been recommended for use with disks to test the susceptibility of microorganisms to cefazolin uses the 30-mcg cefazolin disk.

Results of the standardized single-disk susceptibility test1 with a 30-mcg cefazolin disk should be interpreted according to the following criteria:

RECOMMENDED RANGES FOR CEFAZOLIN SUSCEPTIBILITY TESTING

Standardized single-disk susceptibility test should be performed ONLY with a 30-mcg cefazolin disk. A report of “Susceptible” indicates that the pathogen is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in the blood. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and that other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms. The 30-mcg cefazolin disk should provide the following zone diameters in these laboratory test quality control strains:

The cefazolin disk should not be used for testing susceptibility to other cephalosporins.

Dilution Techniques

Quantitative methods that are used to determine minimum inhibitory concentrations (MIC) provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure uses a standardized dilution method2 (broth, agar, or microdilution) or equivalent with cefazolin powder. The MIC values obtained should be interpreted according to the following criteria:

Interpretation should be as stated above for results using diffusion techniques.

As with standard diffusion techniques, dilution methods require the use of laboratory control microorganisms. Standard cefazolin powder should provide the following MIC values:

CEFAZOLIN INDICATIONS AND USAGE

Cefazolin Injection, USP is indicated in the treatment of the following infections due to susceptible organisms:

Respiratory Tract Infections:

Due to S. pneumoniae, S. aureus (including β-lactamase-producing strains), and S. pyogenes.

Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available.

Urinary Tract Infections:

Due to E. coli, P. mirabilis.

Skin and Skin Structure Infections:

Due to S. aureus (including β-lactamase-producing strains), S. pyogenes, and other strains of streptococci.

Biliary Tract Infections:

Due to E. coli, various strains of streptococci, P. mirabilis, and S. aureus.

Bone and Joint Infections:

Due to S. aureus.

Genital Infections:

(i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis.

Septicemia:

Due to S. pneumoniae, S. aureus (including β-lactamase-producing strains) P. mirabilis, E. coli.

Endocarditis:

Due to S. aureus (including β-lactamase-producing strains), and S. pyogenes.

Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

Perioperative Prophylaxis:

The prophylactic administration of cefazolin preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones).

The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty).

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.

If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin and other antibacterial drugs, cefazolin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CEFAZOLIN CONTRAINDICATIONS

Cefazolin Injection is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

WARNINGS

BEFORE THERAPY WITH CEFAZOLIN INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFAZOLIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFAZOLIN INJECTION OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefazolin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General

Prolonged use of cefazolin may result in the overgrowth of nonsusceptible organisms. Careful clinical observation of the patient is essential.

When cefazolin is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required (see DOSAGE AND ADMINISTRATION).

As with other β-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function (see DOSAGE AND ADMINISTRATION).

Cefazolin Injection, as with all cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

As with other dextrose-containing solutions, Cefazolin Injection should be prescribed with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

Prescribing Cefazolin Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Use only if solution is clear and container and seals are intact.

Prescribing cefazolin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Patients should be counseled that antibacterial drugs including cefazolin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefazolin Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefazolin or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels.

Drug/Laboratory Test Interactions

A false positive reaction for glucose in the urine may occur with Benedict’s solution, Fehling’s solution or with CLINITEST tablets, but not with enzyme-based tests such as CLINISTIX.

Positive direct and indirect antiglobulin (Coombs) tests have occurred; these may also occur in neonates whose mothers received cephalosporins before delivery.

Carcinogenesis/Mutagenesis

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of cefazolin have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in rats, mice, and rabbits at doses up to 25 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefazolin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

When cefazolin has been administered prior to caesarean section, drug levels in cord blood have been approximately one quarter to one third of maternal drug levels. The drug appears to have no adverse effect on the fetus.

Nursing Mothers

Cefazolin is present in very low concentrations in the milk of nursing mothers. Caution should be exercised when cefazolin is administered to a nursing woman.

Pediatric Use

Cefazolin Injection, USP is designed to deliver a 1 gram dose of cefazolin. To prevent unintentional overdose, Cefazolin Injection, USP should not be used in pediatric patients who require less than the full adult dose of cefazolin.

Geriatric Use

Of the 920 subjects who received cefazolin injection in clinical studies, 313 (34%) were 65 years and over, while 138 (15%) were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS, General and DOSAGE AND ADMINISTRATION).

CEFAZOLIN ADVERSE REACTIONS

The following reactions have been reported:

Gastrointestinal

Diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia, and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Nausea and vomiting have been reported rarely.

Allergic

Anaphylaxis, eosinophilia, itching, drug fever, skin rash, Stevens-Johnson syndrome.

Hematologic

Neutropenia, leukopenia, thrombocytopenia, thrombocythemia.

Hepatic

Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed. As with other cephalosporins, reports of hepatitis have been received.

Renal

As with other cephalosporins, reports of increased BUN and creatinine levels, as well as renal failure, have been received.

Local Reactions

Rare instances of phlebitis have been reported at site of injection. Some induration has occurred.

Other Reactions

Genital and anal pruritus (including vulvar pruritus, genital moniliasis, and vaginitis).

Cephalosporin-class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with cefazolin, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Adverse Reactions: Allergic reactions, urticaria, serum sickness-like reaction, erythema multiforme, toxic epidermal necrolysis, colitis, renal dysfunction, toxic nephropathy, abdominal pain, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestatsis, aplastic anemia, hemolytic anemia, hemorrhage, and superinfection.

Altered Laboratory Tests: Prolonged prothrombin time, positive direct Coombs’ test, false-positive test for urinary glucose, elevated bilirubin, elevated LDH, increased creatinine, pancytopenia, and agranulocytosis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

To report SUSPECTED ADVERSE EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.

CEFAZOLIN DOSAGE AND ADMINISTRATION

Usual Adult Dosage:

Type of Infection	Dose	Frequency
Moderate to severe infections	500 mg to 1 gram	every 6 to 8 hrs.
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)In rare instances, doses of up to 12 grams of Cefazolin Injection per day have been used.	1 gram to 1.5 grams	every 6 hours

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

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.

Dosage Adjustment for Patients With Reduced Renal Function

Cefazolin Injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given ½ the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given ½ the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

DIRECTIONS FOR USE OF CEFAZOLIN INJECTION, USP IN GALAXY CONTAINER (PL 2040 PLASTIC)

Cefazolin Injection, USP in GALAXY Container (PL 2040 Plastic) is to be administered either as a continuous or intermittent infusion using sterile equipment.

Storage

Store in a freezer capable of maintaining a temperature of -20°C (-4°F).

Thawing of Plastic Container

Thaw frozen container at room temperature (25°C/ 77°F) or under refrigeration (5°C/41°F). (DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.)

Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

Do not add supplementary medication.

The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

The thawed solution is stable for 30 days under refrigeration (5°C/41°F) and 48 hours at 25°C/77°F. Do not refreeze thawed antibiotics.

CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for administration:

• Suspend container from eyelet support.
• Remove protector from outlet port at bottom of container.
• Attach administration set. Refer to complete directions accompanying set.

HOW SUPPLIED

Cefazolin Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY plastic containers as follows:

STORAGE AND HANDLING

Store at or below -20°C/-4°F. [See Directions for use of GALAXY Container (PL 2040 Plastic).]

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Rx Only

REFERENCES

• National Committee for Clinical Laboratory Standards (NCCLS). January 2003. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Eighth Edition. NCCLS Document M2-A8 and Disk Diffusion Supplemental Tables M100-S13. NCCLS, Wayne, PA, USA.
• National Committee for Clinical Laboratory Standards (NCCLS). January 2003. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Approved Standard-Sixth Edition. NCCLS Document M7-A6 and MIC Testing Supplemental Tables, M100-S13. NCCLS, Wayne, PA, USA.

Baxter and Galaxy are registered trademarks of Baxter International Inc.

Clinitest is a registered trademark of Siemens Healthcare Diagnostics Inc.

Clinistix is a registered trademark of Bayer Healthcare LLC.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

07-19-69-142

Revision Jan 2013

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Baxter logo
Cefazolin Injection, USP
12 - 50 mL Single Dose Containers Iso-osmotic
Store at or below -20°C/-4°F. Do not refreeze.

1 g
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

NDC 0338-3503-41
Code 2G3503
*FOR BAR CODE POSITION ONLY
(01) 20303383503415

GALAXY Container

Sterile Nonpyrogenic

Each 50 mL contains: Cefazolin Sodium equivalent to 1 g of Cefazolin, USP with approx. 2 g
Dextrose Hydrous, USP added to adjust osmolality. pH adjusted with sodium bicarbonate.

Usual Dosage: For I.V. use only. See insert.

Cautions: Do not add supplementary medications or additives. Must not be used in series
connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found,
discard bag as sterility may be impaired. Do not use unless solution is clear. Rx only

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE
THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution is stable for 30 days under refrigeration (5°C/41°F) and 48 hours at room temperature (25°C/77°F). Do not refreeze.

Handle frozen product containers with care. Product containers may be fragile in the
frozen state.

Baxter and Galaxy are trademarks of Baxter International Inc.

PL 2040 Plastic

07-04-65-178