To reduce the development of drug-resistant bacteria andmaintain the effectiveness of cefazolin and other antibacterial drugs, cefazolinshould be used only to treat or prevent infections that are proven or stronglysuspected to be caused by bacteria.
DESCRIPTION
Cefazolin for injection is a sterile, semi-synthetic cephalosporinfor intravenous or intramuscular administration. It is the sodium salt of3-{[(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.
StructuralFormula:

Its molecular formula is C14H13N8NaO4S3 andthe molecular weight is 476.50.
Each vial contains 48mg of sodium/1 gram of cefazolin sodium.
Cefazolin forinjection is supplied as a lyophilized form.
Each ADD-Vantage® vialof cefazolin for injection is equivalent to 1 gram cefazolin.
CLINICAL PHARMACOLOGY
Human Pharmacology
After intramuscular administration of cefazolin to normalvolunteers, the mean serum concentrations were 37 mcg/mL at one hour and
3mcg/mL at eight hours following a 500 mg dose, and 64 mcg/mL at one hour and
7mcg/mL at eight hours following a 1 gram dose.
Studieshave shown that following intravenous administration of cefazolin to normalvolunteers, mean serum concentrations peaked at approximately 185 mcg/mL andwere approximately 4 mcg/mL at eight hours for a 1 gram dose.
Theserum half-life for cefazolin is approximately 1.8 hours following I.V. administrationand approximately 2.0 hours following I.M. administration.
Ina study (using normal volunteers) of constant intravenous infusion with dosagesof 3.5 mg/kg for one hour (approximately 250 mg) and 1.5 mg/kg the next twohours (approximately 100 mg), cefazolin produced a steady serum level at thethird hour of approximately 28 mcg/mL.
Studies in patientshospitalized with infections indicate that cefazolin produces mean peak serumlevels approximately equivalent to those seen in normal volunteers.
Bilelevels in patients without obstructive biliary disease can reach or exceedserum levels by up to five times; however, in patients with obstructive biliarydisease, bile levels of cefazolin are considerably lower than serum levels(< 1.0 mcg/mL).
In synovial fluid, the cefazolinlevel becomes comparable to that reached in serum at about four hours afterdrug administration.
Studies of cord blood show prompttransfer of cefazolin across the placenta. Cefazolin is present in very lowconcentrations in the milk of nursing mothers.
Cefazolinis excreted unchanged in the urine. In the first six hours approximately 60%of the drug is excreted in the urine and this increases to 70%-80% within24 hours. Cefazolin achieves peak urine concentrations of approximately 2400mcg/mL and 4000 mcg/mL respectively following 500 mg and 1 gram intramusculardoses.
In patients undergoing peritoneal dialysis (2L/hr.), cefazolin produced mean serum levels of approximately 10 and 30 mcg/mLafter 24 hours’ instillation of a dialyzing solution containing 50mg/L and 150 mg/L, respectively. Mean peak levels were 29 mcg/mL (range 13-44mcg/mL) with 50 mg/L (three patients), and 72 mcg/mL (range 26-142 mcg/mL)with 150 mg/L (six patients). Intraperitoneal administration of cefazolinis usually well tolerated.
Controlled studies on adultnormal volunteers, receiving 1 gram 4 times a day for 10 days, monitoringCBC, SGOT, SGPT, bilirubin, alkaline phosphatase, BUN, creatinine and urinalysis,indicated no clinically significant changes attributed to cefazolin.
Microbiology
In vitro tests demonstratethat the bactericidal action of cephalosporins results from inhibition ofcell wall synthesis. Cefazolin is active against the following organisms in vitro and in clinical infections:
Staphylococcus aureus (including penicillinase-producingstrains)
Staphylococcusepidermidis
Methicillin-resistant staphylococciare uniformly resistant to cefazolin
Group A beta-hemolyticstreptococci and other strains of streptococci (many strains of enterococciare resistant)
Streptococcuspneumoniae
Escherichiacoli
Proteusmirabilis
Klebsiella species
Enterobacteraerogenes
Haemophilusinfluenzae
Most strains of indole positiveProteus (Proteus vulgaris), Enterobactercloacae, Morganella morganii and Providencia rettgeri are resistant. Serratia, Pseudomonas, Mima, Herellea species are almost uniformly resistant to cefazolin.
Disk Susceptibility Tests
Disk diffusion technique
— Quantitative methods that require measurement ofzone diameters give the most precise estimates of antibiotic susceptibility.One such procedure1 has been recommended for use with disks totest susceptibility to cefazolin.
Reports from a laboratoryusing the standardized single-disk susceptibility test1 with a30 mcg cefazolin disk should be interpreted according to the following criteria:
Susceptibleorganisms produce zones of 18 mm or greater, indicating that the tested organismis likely to respond to therapy.
Organisms of intermediatesusceptibility produce zones 15 to 17 mm, indicating that the tested organismwould be susceptible if high dosage is used or if the infection is confinedto tissues and fluids (e.g., urine), in which high antibiotic levels are attained.
Resistantorganisms produce zones of 14 mm or less, indicating that other therapy shouldbe selected.
For gram-positive isolates, a zone of 18mm is indicative of a cefazolin-susceptible organism when tested with eitherthe cephalosporin-class disk (30 mcg cephalothin) or the cefazolin disk (30mcg cefazolin).
Gram-negative organisms should be testedwith the cefazolin disk (using the above criteria), since cefazolin has beenshown by in vitro tests to have activityagainst certain strains of Enterobacteriaceae found resistant when tested with the cephalothin disk. Gram-negativeorganisms having zones of less than 18 mm around the cephalothin disk maybe susceptible to cefazolin.
Standardized proceduresrequire use of control organisms. The 30 mcg cefazolin disk should give zonediameter between 23 and 29 mm for E. coli ATCC25922 and between 29 and 35 mm for S. aureus ATCC 25923.
The cefazolin disk should notbe used for testing susceptibility to other cephalosporins.
Dilution techniques
— A bacterial isolate may be considered susceptibleif the minimal inhibitory concentration (MIC) for cefazolin is not more than16 mcg per mL. Organisms are considered resistant if the MIC is equal to orgreater than 64 mcg per mL.
The range of MIC’sfor the control strains are as follows:
S.aureus ATCC 25923, 0.25 − 1.0 mcg/mL
E. coli ATCC 25922, 1.0 − 4.0 mcg/mL
INDICATIONS AND USAGE
Cefazolin is indicated in the treatment of the followingserious infections due to susceptible organisms:
RESPIRATORYTRACT INFECTIONS due to Streptococcus pneumoniae, Klebsiella species, Haemophilus influenzae, Staphylococcusaureus (penicillin-sensitive and penicillin-resistant) and groupA beta-hemolytic streptococci.
Injectable benzathinepenicillin is considered to be the drug of choice in treatment and preventionof streptococcal infections, including the prophylaxis of rheumatic fever.
Cefazolinis effective in the eradication of streptococci from the nasopharynx; however,data establishing the efficacy of cefazolin in the subsequent prevention ofrheumatic fever are not available at present.
URINARYTRACT INFECTIONS due to Escherichia coli, Proteus mirabilis, Klebsiella species and some strains of enterobacter and enterococci.
SKINAND SKIN STRUCTURE INFECTIONS due to Staphylococcusaureus (penicillin-sensitiveand penicillin-resistant), group A beta-hemolytic streptococci and other strainsof streptococci.
BILIARY TRACT INFECTIONS due to Escherichiacoli, various strains of streptococci, Proteusmirabilis, Klebsiella speciesand Staphylococcusaureus.
BONE AND JOINT INFECTIONS due to Staphylococcus aureus.
GENITALINFECTIONS (i.e., prostatitis, epididymitis) due to Escherichiacoli, Proteusmirabilis, Klebsiella species andsome strains of enterococci.
SEPTICEMIA due to Streptococcus pneumoniae, Staphylococcusaureus (penicillin-sensitive and penicillin-resistant), Proteus mirabilis, Escherichiacoli and Klebsiella species.
ENDOCARDITISdue to Staphylococcus aureus (penicillin-sensitiveand penicillin-resistant) and group A beta-hemolytic streptococci.
Appropriateculture and susceptibility studies should be performed to determine susceptibilityof the causative organism to cefazolin.
PERIOPERATIVEPROPHYLAXIS: The prophylactic administration of cefazolin preoperatively,intraoperatively and postoperatively may reduce the incidence of certain postoperativeinfections in patients undergoing surgical procedures which are classifiedas contaminated or potentially contaminated (e.g., vaginal hysterectomy, andcholecystectomy in high-risk patients such as those over 70 years of age,with acute cholecystitis, obstructive jaundice or common duct bile stones).
Theperioperative use of cefazolin may also be effective in surgical patientsin whom infection at the operative site would present a serious risk (e.g.,during open-heart surgery and prosthetic arthroplasty).
Theprophylactic administration of cefazolin should usually be discontinued withina 24-hour period after the surgical procedure. In surgery where the occurrenceof infection may be particularly devastating (e.g., open-heart surgery andprosthetic arthroplasty), the prophylactic administration of cefazolin maybe continued for 3 to 5 days following the completion of surgery.
Ifthere are signs of infection, specimens for cultures should be obtained forthe identification of the causative organism so that appropriate therapy maybe instituted.
(See DOSAGE AND ADMINISTRATION.)
Toreduce the development of drug-resistant bacteria and maintain the effectivenessof cefazolin, and other antibacterial drugs, cefazolin should be used onlyto treat or prevent infections that are proven or strongly suspected to becaused by susceptible bacteria. When culture and susceptibility informationare available, they should be considered in selecting or modifying antibacterialtherapy. In the absence of such data, local epidemiology and susceptibilitypatterns may contribute to the empiric selection of therapy.
CONTRAINDICATIONS
CEFAZOLIN IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGYTO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.
WARNINGS
BEFORE THERAPYWITH CEFAZOLIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINEWHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME,CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVENTO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITYAMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR INUP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGICREACTION TO CEFAZOLIN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITYREACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES,INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES,AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Pseudomembranous colitis has been reported with nearly allantibacterial agents, including cefazolin, and may range in severity frommild to life-threatening. Therefore, it is important to consider this diagnosisin patients who present with diarrhea subsequent to the administration ofantibacterial agents.
Treatment with antibacterialagents alters the normal flora of the colon and may permit overgrowth of clostridia.Studies indicate that a toxin produced by Clostridiumdifficile is one primarycause of ‘‘antibiotic-associated colitis.’’
Afterthe diagnosis of pseudomembranous colitis has been established, therapeuticmeasures should be initiated. Mild cases of pseudomembranous colitis usuallyrespond to drug discontinuation alone. In moderate to severe cases, considerationshould be given to management with fluids and electrolytes, protein supplementationand treatment with an antibacterial drug clinically effective against C. difficile colitis.
PRECAUTIONS
General
— Prolonged use of cefazolin may result in the overgrowthof nonsusceptible organisms. Careful clinical observation of the patient isessential.
When cefazolin is administered to patientswith low urinary output because of impaired renal function, lower daily dosageis required.
(See DOSAGE AND ADMINISTRATION.)
Aswith other beta-lactam antibiotics, seizures may occur if inappropriatelyhigh doses are administered to patients with impaired renal function.
(SeeDOSAGE AND ADMINISTRATION.)
Cefazolin, as with all cephalosporins,should be prescribed with caution in individuals with a history of gastrointestinaldisease, particularly colitis.
Cephalosporins may beassociated with a fall in prothrombin activity. Those at risk include patientswith renal or hepatic impairment or poor nutritional state, as well as patientsreceiving a protracted course of antimicrobial therapy, and patients previouslystabilized on anticoagulant therapy. Prothrombin time should be monitoredin patients at risk and exogenous vitamin K administered as indicated.
Prescribingcefazolin in the absence of a proven or strongly suspected bacterial infectionor a prophylactic indication is unlikely to provide benefit to the patientand increases the risk of the development of drug-resistant bacteria.
Drug Interactions
— Probenecid may decrease renal tubular secretionof cephalosporins when used concurrently, resulting in increased and moreprolonged cephalosporin blood levels.
Drug/Laboratory Test Interactions
— A false positive reaction for glucose in the urinemay occur with Benedict’s solution, Fehling’s solution or withClinitest® tablets, but not with enzyme-based tests such asClinistix®.
Positive direct and indirectantiglobulin (Coombs) tests have occurred; these may also occur in neonateswhose mothers received cephalosporins before delivery.
Information for Patients
Patients should be counseledthat antibacterial drugs including cefazolin, should only be used to treatbacterial infections. They do not treat viral infections (e.g., the commoncold). When cefazolin is prescribed to treat a bacterial infection, patientsshould be told that although it is common to feel better early in the courseof therapy, the medication should be taken exactly as directed. Skipping dosesor not completing the full course of therapy may: (1) decrease the effectivenessof the immediate treatment, and (2) increase the likelihood that bacteriawill develop resistance and will not be treatable by cefazolin or other antibacterialdrugs in the future.
Carcinogenesis/Mutagenesis
— Mutagenicity studies and long-term studies in animalsto 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 dosesup to 25 times the human dose and have revealed no evidence of impaired fertilityor harm to the fetus due to cefazolin. There are, however, no adequate andwell-controlled studies in pregnant women. Because animal reproduction studiesare not always predictive of human response, this drug should be used duringpregnancy only if clearly needed.
Labor and Delivery
— When cefazolin has been administered prior to caesareansection, drug levels in cord blood have been approximately one quarter toone third of maternal drug levels. The drug appears to have no adverse effecton the fetus.
Nursing Mothers
— Cefazolin is present in very low concentrationsin the milk of nursing mothers. Caution should be exercised when cefazolinis administered to a nursing woman.
Pediatric Use
— Safety and effectiveness for use in premature infantsand neonates have not been established. See DOSAGE AND ADMINISTRATION forrecommended dosage in pediatric patients over one month.
ADVERSE REACTIONS
The following reactions have been reported:
Gastrointestinal
Diarrhea, oral candidiasis (oral thrush), vomiting, nausea,stomach cramps, anorexia and pseudomembranous colitis. Onset of pseudomembranouscolitis symptoms may occur during or after antibiotic treatment (see WARNINGS).Nausea and vomiting have been reported rarely.
Allergic: Anaphylaxis, eosinophilia, itching, drugfever, skin rash, Stevens-Johnson syndrome.
Hematologic
Neutropenia, leukopenia, thrombocytopenia, thrombocythemia.
Hepatic: Transient rise in SGOT, SGPT and alkalinephosphatase levels has been observed. As with other cephalosporins, reportsof hepatitis have been received.
Renal
As with other cephalosporins, reports of increased BUN andcreatinine levels, as well as renal failure, have been received.
Local Reactions
Rare instances of phlebitis have been reported at site ofinjection. Pain at the site of injection after intramuscular administrationhas occurred infrequently. Some induration has occurred.
Other Reactions
Genital and anal pruritus (including vulvar pruritus, genitalmoniliasis and vaginitis).
DOSAGE AND ADMINISTRATION
NOTE: Cefazolin for injectionin the ADD-Vantage® Vial is not intended for direct intravenousor intramuscular injection.
Usual AdultDosage
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+ cocci
|
250 mg to 500 mg
|
every 8 hours
|
Acute, uncomplicated urinary
tractinfections
|
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
|
Perioperative Prophylactic Use
Toprevent postoperative infection in contaminated or potentially contaminatedsurgery, recommended doses are:
a.1 gram I.V. or I.M.administered 1/2 hour to 1 hour prior to the start of surgery.
b.For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gramI.V. or I.M. during surgery (administration modified depending on the durationof the operative procedure).
c.500 mg to 1 gram I.V.or I.M. every 6 to 8 hours for 24 hours postoperatively.
Itis important that 1) the preoperative dose be given just (1/2 to 1 hour) priorto the start of surgery so that adequate antibiotic levels are present inthe serum and tissues at the time of initial surgical incision; and 2) cefazolinbe administered, if necessary, at appropriate intervals during surgery toprovide sufficient levels of the antibiotic at the anticipated moments ofgreatest exposure to infective organisms.
In surgerywhere the occurrence of infection may be particularly devastating (e.g., open-heartsurgery and prosthetic arthroplasty), the prophylactic administration of cefazolinmay be continued for 3 to 5 days following the completion of surgery.
Dosage Adjustment for Patients with Reduced Renal Function
Cefazolin may be used in patientswith reduced renal function with the following dosage adjustments: Patientswith a creatinine clearance of 55 mL/min. or greater or a serum creatinineof 1.5 mg% or less can be given full doses. Patients with creatinine clearancerates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg% can also begiven 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 creatinineof 3.1 to 4.5 mg% should be given 1/2 the usual dose every 12 hours. Patientswith creatinine clearance rates of 10 mL/min. or less or serum creatinineof 4.6 mg% or greater should be given 1/2 the usual dose every 18 to 24 hours.All reduced dosage recommendations apply after an initial loading dose appropriateto the severity of the infection. Patients undergoing peritoneal dialysis:See Human Pharmacology.
PediatricDosage
In pediatric patients, a total dailydosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of bodyweight, divided into three or four equal doses, is effective for most mildto moderately severe infections. Total daily dosage may be increased to 100mg per kg (45 mg per pound) of body weight for severe infections. Since safetyfor use in premature infants and in neonates has not been established, theuse of cefazolin in these patients is not recommended.
Pediatric Dosage Guide
|
Weight
|
25 mg/kg/Day
Divided into 3Doses
|
25 mg/kg/Day
Divided into 4Doses
|
Lbs
|
Kg
|
Approximate Single
Dosemg/q8h
|
Vol. (mL) needed with
dilutionof 125 mg/mL
|
Approximate Single Dose mg/q6h
|
Vol. (mL) needed with dilution of 125 mg/mL
|
10
|
4.5
|
40 mg
|
0.35 mL
|
30 mg
|
0.25 mL
|
20
|
9.0
|
75 mg
|
0.60 mL
|
55 mg
|
0.45 mL
|
30
|
13.6
|
115 mg
|
0.90 mL
|
85 mg
|
0.70 mL
|
40
|
18.1
|
150 mg
|
1.20 mL
|
115 mg
|
0.90 mL
|
50
|
22.7
|
190 mg
|
1.50 mL
|
140 mg
|
1.10 mL
|
Weight
|
50mg/kg/Day
Divided into 3Doses
|
50mg/kg/Day
Divided into 4Doses
|
Lbs
|
Kg
|
Approximate Single
Dosemg/q8h
|
Vol. (mL) needed with
dilutionof 225 mg/mL
|
Approximate Single Dose mg/q6h
|
Vol. (mL) needed with dilution of 225 mg/mL
|
10
|
4.5
|
75 mg
|
0.35 mL
|
55 mg
|
0.25 mL
|
20
|
9.0
|
150 mg
|
0.70 mL
|
110 mg
|
0.50 mL
|
30
|
13.6
|
225 mg
|
1.00 mL
|
170 mg
|
0.75 mL
|
40
|
18.1
|
300 mg
|
1.35 mL
|
225 mg
|
1.00 mL
|
50
|
22.7
|
375 mg
|
1.70 mL
|
285 mg
|
1.25 mL
|
In pediatric patients with mild to moderate renal impairment(creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal dailydose given in equally divided doses every 12 hours should be sufficient. Inpatients with moderate impairment (creatinine clearance of 40 to 20 mL/min.),25 percent of the normal daily dose given in equally divided doses every 12hours should be adequate. Pediatric patients with severe renal impairment(creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normaldaily dose every 24 hours. All dosage recommendations apply after an initialloading dose.
RECONSTITUTION
Preparation of Parenteral Solution
Parenteral drug products should be SHAKEN WELL when reconstituted,and inspected visually for particulate matter and discoloration prior to administration.If particulate matter is evident in reconstituted fluids, the drug solutionsshould be discarded.
When reconstituted or diluted accordingto the instructions below, cefazolin for injection is stable for 24 hoursat room temperature. Reconstituted solutions may range in color from paleyellow to yellow without a change in potency.
ADD-Vantage® Vials
ADD-Vantage® Vialsof cefazolin for injection are to be reconstituted only with 0.9% Sodium ChlorideInjection or 5% Dextrose Injection in the 50 mL or 100 mL ADD-Vantage® FlexibleDiluent Containers or with 0.45% Sodium Chloride Injection in the 50mLADD-Vantage® Flexible Diluent Container. Cefazolin for injectionsupplied in single-dose ADD-Vantage® Vials should be preparedas directed below.
INSTRUCTIONS FOR USE
To Open Diluent Container:
Peeloverwrap at corner and remove solution container. Some opacity of the plasticdue to moisture absorption during the sterilization process may be observed.This is normal and does not affect the solution quality or safety. The opacitywill diminish gradually.
ToAssemble Vial and Flexible Diluent Container:
(Use Aseptic Technique)
1.Remove the protective covers from the top of the vial and the vial port onthe diluent container as follows:
a.To remove the breakawayvial cap, swing the pull ring over the top of the vial and pull down far enoughto start the opening (SEE FIGURE 1), then pull straight up to remove the cap(SEE FIGURE 2).
NOTE: Oncethe breakaway cap has been removed, do not access vial with syringe.


Fig. 1Fig. 2
b.To remove the vial port cover, grasp the tab on the pull ring, pull up tobreak the three tie strings, then pull back to remove the cover (SEE FIGURE3).
2.Screw the vial into the vial port until it willgo no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. Thisoccurs approximately 1/2 turn (180°) after the first audible click (SEEFIGURE 4). The clicking sound does not assure a seal; the vial must be turnedas far as it will go.
NOTE: Once vial is seated, do not attempt to remove (SEE FIGURE 4).
3.Recheck the vial to assure that it is tight by trying to turn it further inthe direction of assembly.
4.Label appropriately.


Fig. 3Fig. 4
To Reconstitute the Drug:
-
Squeeze the bottom of the diluent container gently to inflate the portionof the container surrounding the end of the drug vial.
-
With the other hand, push the drug vial down into the container telescopingthe walls of the container. Grasp the inner cap of the vial through the wallsof the container (SEE FIGURE 5).
-
Pull the inner cap from the drug vial (SEE FIGURE 6). Verify that therubber stopper has been pulled out, allowing the drug and diluent to mix.
-
Mix container contents thoroughly and use within the specified time.


Fig. 5Fig. 6
Preparation for Administration:
(Use Aseptic Technique)
-
Confirm the activation and admixture of vial contents.
-
Check for leaks by squeezing container firmly. If leaks are found, discardunit as sterility may be impaired.
-
Close flow control clamp of administration set.
-
Remove cover from outlet port at bottom of container.
-
Insert piercing pin of administration set into port with a twistingmotion until the pin is firmly seated. NOTE: Seefull directions on administration set carton.
-
Lift the free end of the hanger loop on the bottom of the vial, breakingthe two tie strings. Bend the loop outward to lock it in the upright position,then suspend container from hanger.
-
Squeeze and release drip chamber to establish proper fluid level inchamber.
-
Open flow control clamp and clear air from set. Close clamp.
-
Attach set to venipuncture device. If device is not indwelling, primeand make venipuncture.
-
Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible containerin series connections.
Compatibilityand Stability
Ordinarily ADD-Vantage® Vialsshould be reconstituted only when it is certain that the patient is readyto receive the drug. However, cefazolin for injection in ADD-Vantage® vialsis stable for 24 hours at room temperature when reconstituted as directed(see RECONSTITUTION, ADD-Vantage® Vials and INSTRUCTIONS FORUSE). (DO NOT REFRIGERATE OR FREEZE CEFAZOLIN SODIUM IN ADD-VANTAGE® VIALS.)
HOW SUPPLIED
Cefazolin for injection is supplied in ADD-Vantage® Vialsequivalent to 1 gram of cefazolin in packages of 25 (NDC 0074-4732-03).
Aswith other cephalosporins, cefazolin for injection tends to darken dependingon storage conditions; within the stated recommendations, however, productpotency is not adversely affected.
Before reconstitution,protect from light and store at Controlled Room Temperature 20° to 25°C(68° to 77°F).
REFERENCE
1Bauer, A.W.; Kirby, W.M.M.; Sherris, J.C., andTurck, M.: Antibiotic Testing by a Standardized Single Disc Method, Am. J.Clin. Path. 45:493, 1966. Standardized Disc Susceptibility Test, Federal Register39:19182-19184, 1974.
CE:L7AV685651/58-7297-R8-Rev.FEB. 2004
©2004, GlaxoSmithKline
Allrights reserved.
Manufactured by
GlaxoSmithKline
ResearchTriangle Park, NC 27709
for ABBOTTLABORATORIES, NORTH CHICAGO, IL 60064, USA
Revised: 12/2006