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Cefuroxime is a semisynthetic, broad spectrum cephalosporin antibiotic for intravenous administration. It is the sodium salt of (6R,7R)3-carbamoyloxymethyl-7-[Z-2-methoxy-imino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the following structural formula:
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The chemical formula is C 16 H 15 N 4 NaO 8 S, and the molecular weight is 446.37.
Kefurox contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity.
Kefurox in sterile crystalline form is supplied in vials equivalent to 750 mg, 1.5 g, or 7.5 g of cefuroxime as cefuroxime sodium. Solutions of Kefurox range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 4.5-8.5.
Following IV doses of 750 mg and 1.5 g, serum concentrations were approximately 50 and 100 mcg/mL, respectively, at 15 minutes. Therapeutic serum concentrations of approximately 2 mcg/mL or more were maintained for 5.3 hours and 8 hours or more, respectively. There was no evidence of accumulation of cefuroxime in the serum following IV administration of 1.5-g doses every 8 hours to normal volunteers. The serum half-life after IV injections is approximately 80 minutes.
Approximately 89% of a dose of cefuroxime is excreted by the kidneys over an 8-hour period, resulting in high urinary concentrations.
Intravenous doses of 750 mg and 1.5 g produced urinary levels averaging 1,150 and 2,500 mcg/mL, respectively, during the first 8-hour period.
The concomitant oral administration of probenecid with cefuroxime slows tubular secretion, decreases renal clearance by approximately 40%, increases the peak serum level by approximately 30%, and increases the serum half-life by approximately 30%. Cefuroxime is detectable in therapeutic concentrations in pleural fluid, joint fluid, bile, sputum, bone, cerebrospinal fluid (in patients with meningitis), and aqueous humor.
Cefuroxime is approximately 50% bound to serum protein.
Microbiology: Cefuroxime has in vitro activity against a wide range of gram-positive and gram-negative organisms, and it is highly stable in the presence of beta-lactamases of certain gram-negative bacteria. The bactericidal action of cefuroxime results from inhibition of cell-wall synthesis.
Cefuroxime is usually active against the following organisms in vitro .
Aerobes, Gram-positive: Staphylococcus aureus; Staphylococcus epidermidis; Streptococcus pneumoniae; and Streptococcus pyogenes (and other streptococci).
NOTE: Most strains of enterococci, e.g., Enterococcus faecalis (formerly Streptococcus faecalis ), are resistant to cefuroxime. Methicillin-resistant staphylococci and Listeria monocytogenes are resistant to cefuroxime.
Aerobes, Gram-negative: Citrobacter spp; Enterobacter spp.; Escherichia coli; Haemophilus influenzae (including ampicillin-resistant strains); Haemophilus parainfluenzae; Klebsiella spp. (including Klebsiella pneumoniae); Moraxella (Branhamella) catarrhalis (including ampicillin- and cephalothin-resistant strains); Morganella morganii (formerly Proteus morganii ); Neisseria gonorrhoeae (including penicillinase- and non-penicillinase-producing strains); Neisseria meningitidis; Proteus mirabilis; Providencia rettgeri (formerly Proteus rettgeri); Salmonella spp.; and Shigella spp.
NOTE: Some strains of Morganella morganii, Enterobacter cloacae , and Citrobacter spp. have been shown by in vitro tests to be resistant to cefuroxime and other cephalosporins. Pseudomonas and Campylobacter spp., Acinetobacter calcoaceticus, and most strains of Serratia spp. and Proteus vulgaris are resistant to most first- and second-generation cephalosporins.
Anaerobes: Gram-positive and gram-negative cocci (including Peptococcus and Peptostreptococcus spp); gram-positive bacilli (including Clostridium spp); gram-negative bacilli (including Bacteroides and Fusobacterium spp).
NOTE: Clostridium difficile and most strains of Bacteroides fragilis are resistant to cefuroxime.
Susceptibility Tests: Diffusion Techniques: Quantitative methods that require measurement of zone diameters give an estimate of antibiotic susceptibility. One such standard procedure 1 that has been recommended for use with disks to test susceptibility of organisms to cefuroxime uses the 30-mcg cefuroxime disk. Interpretation involves the correlation of the diameters obtained in the disk test with minimum inhibitory concentration (MIC) for cefuroxime.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of "Moderately Susceptible" suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissues and fluids in which high antibiotic levels are attained. A report of "Intermediate" suggests an equivocable or indeterminate result. A report of "Resistant" indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected.
Reports from the laboratory giving results of the standard single-disk susceptibility test for organisms other than Haemophilus spp. and Neisseria gonorrhoeae with a 30-mcg cefuroxime disk should be interpreted according to the following criteria:
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Results for Haemophilus spp. should be interpreted according to the following criteria:
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Results for Neisseria gonorrhoeae should be interpreted according to the following criteria:
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Organisms should be tested with the cefuroxime disk since cefuroxime has been shown by in vitro tests to be active against certain strains found resistant when other beta-lactam disks are used. The cefuroxime disk should not be used for testing susceptibility to other cephalosporins.
Standardized procedures require the use of laboratory control organisms. The 30-mcg cefuroxime disk should give the following zone diameters
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Dilution Techniques: Use a standardized dilution method 1 (broth, agar, microdilution) or equivalent with cefuroxime powder. The MIC values obtained for bacterial isolates other than Haemophilus spp. and Neisseria gonorrhoeae should be interpreted according to the following criteria:
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MIC values obtained for Haemophilus spp. should be interpreted according to the following criteria:
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MIC values obtained for Neisseria gonorrhoeae should be interpreted according to the following criteria:
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As with standard diffusion techniques, dilution methods require the use of laboratory control organisms. Standard cefuroxime powder should provide the following MIC values.
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Kefurox is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Clinical microbiological studies in skin and skin structure infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Kefurox has been used successfully in these mixed infections in which several organisms have been isolated. Appropriate cultures and susceptibility studies should be performed to determine the susceptibility of the causative organisms to Kefurox (cefuroxime for injection).
Therapy may be started while awaiting the results of these studies; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, Kefurox may be used concomitantly with an aminoglycoside ( see PRECAUTIONS ). The recommended doses of both antibiotics may be given depending on the severity of the infection and the patient's condition.
Prevention: The preoperative prophylactic administration of Kefurox may prevent the growth of susceptible disease-causing bacteria and, thereby may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (e.g., vaginal hysterectomy) that are classified as clean-contaminated or potentially contaminated procedures. Effective prophylactic use of antibiotics in surgery depends on the time of administration. Kefurox should usually be given one-half to 1 hour before the operation to allow sufficient time to achieve effective antibiotic concentrations in the wound tissues during the procedure. The dose should be repeated intraoperatively if the surgical procedure is lengthy.
Prophylactic administration is usually not required after the surgical procedure ends and should be stopped within 24 hours. In the majority of surgical procedures, continuing prophylactic administration of any antibiotic does not reduce the incidence of subsequent infections but will increase the possibility of adverse reactions and the development of bacterial resistance.
The perioperative use of Kefurox has also been effective during open heart surgery for surgical patients in whom infections at the operative site would present a serious risk. For these patients, it is recommended that Kefurox therapy be continued for at least 48 hours after the surgical procedure ends. If an infection is present, specimens for culture should be obtained for the identification of the causative organism, and appropriate antimicrobial therapy should be instituted.
Kefurox is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
BEFORE THERAPY WITH KEFUROX IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO KEFUROX (CEFUROXIME FOR INJECTION) OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.
Pseudomembranous colitis has been reported with the use of cephalosporins (and other broad-spectrum antibiotics); therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use.
Treatment with broad-spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis. Cholestyramine and colestipol resins have been shown to bind the toxin in vitro .
Mild cases of colitis may respond to drug discontinuation alone. Moderate to severe cases should be managed with fluid, electrolyte, and protein supplementation as indicated.
When the colitis is not relieved by drug discontinuation or when it is severe, oral vancomycin is the treatment of choice for antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. Other causes of colitis should also be considered.
General:
Although Kefurox rarely produces alterations in kidney function, evaluation of renal status during therapy is recommended, especially in seriously ill patients receiving the maximum doses. Cephalosporins should be given with caution to patients receiving concurrent treatment with potent diuretics as these regimens are suspected of adversely affecting renal function.
The total daily dose of Kefurox should be reduced in patients with transient or persistent renal insufficiency ( see DOSAGE AND ADMINISTRATION ), because high and prolonged serum antibiotic concentrations can occur in such individuals from usual doses.
As with other antibiotics, prolonged use of Kefurox may result in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporins.
As with other therapeutic regimens used in the treatment of meningitis, mild-to-moderate hearing loss has been reported in some pediatric patients treated with cefuroxime sodium. Persistence of positive CSF (cerebrospinal fluid) cultures at 18 to 36 hours, particularly in patients with Haemophilus influenzae isolates, has also been noted; however, the precise clinical impact of this is unknown.
Drug/Laboratory Test Interactions: A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling' solution or with Clintest® tablets) but not with enzyme-based tests for glycosuria (e.g., Tes-Tape®, Glucose Enzymatic Test Strips, USP). As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood plasma glucose levels in patients receiving Kefurox.
Cefuroxime does not interfere with the assay of serum and urine creatinine by the the alkaline picrate method.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no mutagenic potential of cefuroxime was found in standard laboratory tests.
Reproductive studies revealed no impairment of fertility in animals.
Pregnancy: Effects: Pregnancy Category B --Reproduction studies have been performed in mice and rabbits at doses up to 60 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime. There are, however, no adequate 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.
Nursing Mothers: Since Kefurox is excreted in human milk, caution should be exercised when Kefurox is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 months have not been established. Accumulation of other members of the cephalosporin class in newborn infants (with resulting prolongation of drug half-life) has been reported.
Kefurox is generally well tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely.
Local Reactions --Thrombophlebitis has occurred with IV administration in 1 in 60 patients.
Gastrointestinal --Gastrointestinal symptoms occurred in 1 in 150 patients and included diarrhea (1 in 220 patients) and nausea (1 in 440 patients). Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (see ).
Hypersensitivity Reactions --Hypersensitivity reactions have been reported in fewer than 1% of the patients treated with Kefurox and include rash (1 in 125). Pruritus, urticaria and positive Coombs' test each occurred in less than 1 in 250 patients, and, as with other cephalosporins, rare cases of anaphylaxis, drug fever, erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome have occurred.
Blood --A decrease in hemoglobin and hematocrit has been observed in 1 in 10 patients and transient eosinophilia in 1 in 14 patients. Less common reactions seen were transient neutropenia (fewer than 1 in 100 patients) and leukopenia (1 in 750 patients). A similar pattern and incidence were seen with other cephalosporins used in controlled studies. As with other cephalosporins, there have been rare reports of thrombocytopenia.
Hepatic --Transient rise in AST (SGOT) and ALT (SGPT) (1 in 25 patients), alkaline phosphatase (1 in 50 patients), LDH (1 in 75 patients), and bilirubin (1 in 500 patients) levels has been noted.
Kidney --Elevations in serum creatinine and/or blood urea nitrogen and a decreased creatinine clearance have been observed, but their relationship to cefuroxime is unknown.
In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Adverse Reactions: Vomiting, abdominal pain, colitis, vaginitis including vaginal candidiasis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage.
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 should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Altered Laboratory Tests: Prolonged prothrombin time, pancytopenia, agranulocytosis.
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
DOSAGE: Adults-- The usual adult dosage range for Kefurox (cefuroxime for injection) is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750-mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5-gram dose every 8 hours is recommended.
In bone and joint infections, a 1.5 gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to Kefurox therapy. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of Kefurox.
In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dose should not exceed 3 grams every 8 hours. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5-gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously every 8 hours when the procedure is prolonged.
For preventive use during open heart surgery, a 1.5-gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.
Impaired Renal Function -- A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 1).
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When only serum creatinine is available, the following formula 2 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
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Males: Creatinine Clearance (mL/min) =
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Note: As with antibiotic therapy in general, administration of Kefurox should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.
Infants and Children Above 3 Months of Age --Administration of 50 to 100 mg/kg/day in equally divided doses, every 6 to 8 hours, has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg/day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.
In bone and joint infections, 150 mg/kg per day (not to exceed the maximum adult dose) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to children following the completion of parenteral administration of Kefurox.
In cases of bacterial meningitis, a larger dosage of Kefurox is recommended, 200 to 240 mg/kg per day intravenously in divided doses every 6 to 8 hours.
In children with renal insufficiency, the frequency of dosing should be modified to be consistent with the recommendations for adults.
Preparation of Solution: The directions for preparing Kefurox (cefuroxime for injection) for IV use is summarized in Table 2.
For Intravenous Use: Each 750-mg vial/10-mL should be constituted with 7 mL of sterile water for injection. Withdraw completely the resulting solution for injection.
Each 1.5-g vial should be constituted with 14 mL of sterile water for injection, and the solution should be completely withdrawn for injection.
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Administration: After constitution, Kefurox may be given intravenously.
Intravenous Administration --The IV route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.
For Direct Intermittent IV Administration --Slowly inject the solution into a vein over a period of 3 to 5 minutes or give it through the tubing system by which the patient is also receiving IV solutions.
For Intermittent IV Infusion with a Y-Type Administration Set --Dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions.
However, during infusion of the solution containing Kefurox, it is advisable to temporarily discontinue administration of any other solutions at the same site.
ADD-Vantage® vials are to be constituted only with 50 or 100 mL of 5% dextrose injection, 0.9% sodium chloride injection, or 0.45% sodium chloride injection in Abbott ADD-Vantage flexible diluent containers (see Instructions for Constitution). ADD-Vantage vials that have been joined to Abbott ADD-Vantage diluent containers and activated to disolve the drug are stable for 24 hours at room temperature or for 7 days under refrigeration. Joined vials that have not been activated may be used within a 14-day period; this period corresponds to that for use of Abbott ADD-Vantage containers following removal of the outer packaging (overwrap).
Freezing solutions of Kefurox in the ADD-Vantage system is not recommended.
DIRECTIONS FOR USE OF KEFUROX (cefuroxime for injection) IN ADD-VANTAGE® VIALS
Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container:
(Use Aseptic Technique)
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To Reconstitute the Drug:
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For Continuous IV Infusion --A solution of Kefurox may be added to an IV bottle containing one of the following fluids:
0.9% sodium chloride injection, 5% dextrose injection, 10% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose and 0.45% sodium chloride injection, or 1/6 M sodium lactate injection
Solutions of Kefurox, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.
However, if concurrent therapy with Kefurox (cefuroxime for injection) and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.
Compatibility and Stability --Intravenous--When the 750-mg and 1.5-g vials are constituted as directed with sterile water for injection, the Kefurox solutions for IV administration maintain satisfactory potency for 24 hours at room temperature and for 48 hours (750-mg and 1.5-g vials under refrigeration (5°C). More dilute solutions, such as 750 mg or 1.5 g plus 100 mL of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection, also maintain satisfactory potency for 24 hours at room temperature and for 7 days under refrigeration.
These solutions may be further diluted to concentrations of between 1 and 30 mg/mL in the following solutions and will lose not more than 10% activity for 24 hours at room temperature or for at least 7 days under refrigeration: 0.9% sodium chloride injection; 1/6 M sodium lactate injection; ringer's injection, USP; lactated ringer's injection, USP; 5% dextrose and 0.9% sodium chloride injection; 5% dextrose injection; 5% dextrose and 0.45% sodium chloride injection; 5% dextrose and 0.225% sodium chloride injection; 10% dextrose injection; and 10% invert sugar in water for injection.
Unused solutions should be discarded after the time periods mentioned above.
Kefurox has also been found to be compatible for 24 hours at room temperature when admixed in IV infusion with the following: heparin (10 and 50 units/mL) in 0.9% sodium chloride injection, or potassium chloride (10 and 40 mEq/L) in 0.9% sodium chloride injection. Sodium bicarbonate injection, USP, is not recommended for the dilution of Kefurox.
The 750-mg and 1.5-g Kefurox ADD-Vantage vials, when diluted in 50 or 100 mL of 5% dextrose injection, 0.9% sodium chloride injection, or 0.45% sodium chloride injection, may be stored for up to 24 hours at room temperature or for 7 days under refrigeration.
Frozen Stability: Constitute the 750-mg and 1.5-g vial as directed for IV administration in Table 2. Immediately withdraw the total contents of the 750-mg or 1.5-g vial and add to a Viaflex® Mini-bag™ containing 50 or 100 mL of 0.9% sodium chloride injection or 5% dextrose injection and freeze. Frozen solutions are stable for 6 months when stored at -20 C. Frozen solutions should be thawed at room temperature and not refrozen. Do not force thaw by immersion in water baths or by microwave irradiation. Thawed solutions may be stored for up to 24 hours at room temperature or for 7 days in a refrigerator.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
As with other cephalosporins, Kefurox powder as well as solutions and suspensions tend to darken, depending on storage conditions, without adversely affecting product potency.
Kefurox (cefuroxime for injection) in the dry state should be stored between 15° and 30° C (59° and 86° F) and protected from light. Kefurox is a dry, white to off-white powder supplied in vials as follows:
Vials:
750 mg,* 10-mL size (No. 7271)--(Traypak§ of 25) NDC 0002-7271-25
1.5 g,* 20-mL size (No. 7272)--(Traypak of 10) NDC 0002-7272-10
750 mg,* 100-mL size (No. 7273)--(Traypak of 10) NDC 0002-7273-10
1.5 g,* 100-mL size (No. 7274)--(Traypak of 10) NDC 0002-7274-10
ADD-Vantage^ Vials:
750 mg,* (No. 7278)--(Traypak of 25) NDC 0002-7278-25
1.5 g,* (No. 7279)--(Traypak of 10) NDC 0002-7279-10
The above ADD-Vantage Vials are to be used only with Abbott Laboratories' ADD-Vantage Antibiotic Diluent Container.
Also available:
Pharmacy Bulk Package:
7.5 g,* 100-mL size (No. 7275)--(Traypak of 6) NDC 0002-7275-16
* Equivalent to cefuroxime.
§ Traypak TM (multivial carton, Lilly).
^ ADD-Vantage® (vials and diluent containers, Abbott).
Rx only
Literature issued May, 1998.
Manufactured for ELI LILLY AND COMPANY,
Indianapolis, IN 46285, USA.
by BMH Limited, Philadelphia, PA 19101
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