Fortaz Information
Fortaz (Ceftazidime)
Fortaz (Ceftazidime) Description
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure:
The empirical formula is CHNOS, representing a molecular weight of 636.6.
Fortaz (Ceftazidime) is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity.
Fortaz (Ceftazidime) in sterile crystalline form is supplied in vials equivalent to 500 mg, 1 g, 2 g, or 6 g of anhydrous ceftazidime and in ADD-Vantage vials equivalent to 1 or 2 g of anhydrous ceftazidime. Solutions of Fortaz (Ceftazidime) range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 8.
Fortaz (Ceftazidime) is available as a frozen, iso-osmotic, sterile, nonpyrogenic solution with 1 or 2 g of ceftazidime as ceftazidime sodium premixed with approximately 2.2 or 1.6 g, respectively, of Dextrose Hydrous, USP. Dextrose has been added to adjust the osmolality. Sodium hydroxide is used to adjust pH and neutralize ceftazidime pentahydrate free acid to the sodium salt. The pH may have been adjusted with hydrochloric acid. Solutions of premixed Fortaz (Ceftazidime) range in color from light yellow to amber. The solution is intended for intravenous (IV) use after thawing to room temperature. The osmolality of the solution is approximately 300 mOsmol/kg, and the pH of thawed solutions ranges from 5 to 7.5.
The plastic container for the frozen solution 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. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Fortaz (Ceftazidime) Clinical Pharmacology
After IV administration of 500-mg and 1-g doses of ceftazidime over 5 minutes to normal adult male volunteers, mean peak serum concentrations of 45 and 90 mcg/mL, respectively, were achieved. After IV infusion of 500-mg, 1-g, and 2-g doses of ceftazidime over 20 to 30 minutes to normal adult male volunteers, mean peak serum concentrations of 42, 69, and 170 mcg/mL, respectively, were achieved. The average serum concentrations following IV infusion of 500-mg, 1-g, and 2-g doses to these volunteers over an 8-hour interval are given in Table 1.
The absorption and elimination of ceftazidime were directly proportional to the size of the dose. The half-life following IV administration was approximately 1.9 hours. Less than 10% of ceftazidime was protein bound. The degree of protein binding was independent of concentration. There was no evidence of accumulation of ceftazidime in the serum in individuals with normal renal function following multiple IV doses of 1 and 2 g every 8 hours for 10 days.
Following intramuscular (IM) administration of 500-mg and 1-g doses of ceftazidime to normal adult volunteers, the mean peak serum concentrations were 17 and 39 mcg/mL, respectively, at approximately 1 hour. Serum concentrations remained above 4 mcg/mL for 6 and 8 hours after the IM administration of 500-mg and 1-g doses, respectively. The half-life of ceftazidime in these volunteers was approximately 2 hours.
The presence of hepatic dysfunction had no effect on the pharmacokinetics of ceftazidime in individuals administered 2 g intravenously every 8 hours for 5 days. Therefore, a dosage adjustment from the normal recommended dosage is not required for patients with hepatic dysfunction, provided renal function is not impaired.
Approximately 80% to 90% of an IM or IV dose of ceftazidime is excreted unchanged by the kidneys over a 24-hour period. After the IV administration of single 500-mg or 1-g doses, approximately 50% of the dose appeared in the urine in the first 2 hours. An additional 20% was excreted between 2 and 4 hours after dosing, and approximately another 12% of the dose appeared in the urine between 4 and 8 hours later. The elimination of ceftazidime by the kidneys resulted in high therapeutic concentrations in the urine.
The mean renal clearance of ceftazidime was approximately 100 mL/min. The calculated plasma clearance of approximately 115 mL/min indicated nearly complete elimination of ceftazidime by the renal route. Administration of probenecid before dosing had no effect on the elimination kinetics of ceftazidime. This suggested that ceftazidime is eliminated by glomerular filtration and is not actively secreted by renal tubular mechanisms.
Since ceftazidime is eliminated almost solely by the kidneys, its serum half-life is significantly prolonged in patients with impaired renal function. Consequently, dosage adjustments in such patients as described in the DOSAGE AND ADMINISTRATION section are suggested.
Therapeutic concentrations of ceftazidime are achieved in the following body tissues and fluids.
Fortaz (Ceftazidime) Indications And Usage
Fortaz (Ceftazidime) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Fortaz (Ceftazidime) may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibiotics have been used.
Fortaz (Ceftazidime) may also be used concomitantly with other antibiotics, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibiotics should be followed. The dose depends on the severity of the infection and the patient's condition.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fortaz (Ceftazidime) and other antibacterial drugs, Fortaz (Ceftazidime) 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.
Fortaz (Ceftazidime) Contraindications
Fortaz (Ceftazidime) is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibiotics.
Fortaz (Ceftazidime) Warnings
BEFORE THERAPY WITH Fortaz (Ceftazidime) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE 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 Fortaz (Ceftazidime) OCCURS, DISCONTINUE 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.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia (see PRECAUTIONS).
Fortaz (Ceftazidime) Precautions
High and prolonged serum ceftazidime concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage should be reduced when ceftazidime is administered to patients with renal insufficiency (see DOSAGE AND ADMINISTRATION). Elevated levels of ceftazidime in these patients can lead to seizures, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms.
As with other antibiotics, prolonged use of Fortaz (Ceftazidime) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Inducible type I beta-lactamase resistance has been noted with some organisms (e.g., spp., spp., and spp.). As with other extended-spectrum beta-lactam antibiotics, resistance can develop during therapy, leading to clinical failure in some cases. When treating infections caused by these organisms, periodic susceptibility testing should be performed when clinically appropriate. If patients fail to respond to monotherapy, an aminoglycoside or similar agent should be considered.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal and hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Fortaz (Ceftazidime) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime.
Prescribing Fortaz (Ceftazidime) 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.
Patients should be counseled that antibacterial drugs, including Fortaz (Ceftazidime) , should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Fortaz (Ceftazidime) 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 Fortaz (Ceftazidime) 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 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibiotics or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycosidic antibiotics. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam antibiotics, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo, particularly when bactericidal activity is desired, this drug combination should be avoided.
In common with other antibiotics, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Fortaz (Ceftazidime) Adverse Reactions
Ceftazidime is generally well tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.
The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology:
Fortaz (Ceftazidime) Postmarketing Experience With Fortaz Products
In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with Fortaz (Ceftazidime) and were reported spontaneously. For some of these events, data are insufficient to allow an estimate of incidence or to establish causation.
Fortaz (Ceftazidime) Overdosage
Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of ceftazidime from the body.
Fortaz (Ceftazidime) Dosage And Administration
The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.
The guidelines for dosage of Fortaz (Ceftazidime) are listed in Table 3. The following dosage schedule is recommended.
*
†
Fortaz (Ceftazidime) supplied as a frozen, sterile, iso-osmotic, nonpyrogenic solution in plastic containers is to be administered after thawing either as a continuous or intermittent IV infusion. The thawed solution is stable for 8 hours at room temperature or for 3 days if stored under refrigeration.
Thaw container at room temperature (25°C) or under refrigeration (5°C). Do not force thaw by immersion in water baths or by microwave irradiation. 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. Mix after solution has reached room temperature. Check for minute leaks by squeezing bag firmly. Discard bag if leaks are found as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.
Use sterile equipment.
Fortaz (Ceftazidime) Compatibility And Stability
Fortaz (Ceftazidime) , when constituted as directed with Sterile Water for Injection, maintains satisfactory potency for 12 hours at room temperature or for 3 days under refrigeration. Solutions in 0.9% Sodium Chloride Injection in VIAFLEX small-volume containers that are frozen immediately after constitution are stable for 3 months when stored at -20°C. Do not force thaw by immersion in water baths or by microwave irradiation. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 12 hours at room temperature or for 3 days in a refrigerator. More concentrated solutions in Sterile Water for Injection in the original container that are frozen immediately after constitution are stable for 3 months when stored at -20°C. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 8 hours at room temperature or for 3 days in a refrigerator.
Fortaz (Ceftazidime) is compatible with the more commonly used IV infusion fluids. Solutions at concentrations between 1 and 40 mg/mL in 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; 5% Dextrose Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose Injection; Ringer's Injection, USP; Lactated Ringer's Injection, USP; 10% Invert Sugar in Water for Injection; and NORMOSOL-M in 5% Dextrose Injection may be stored for up to 12 hours at room temperature or for 3 days if refrigerated.
The 1- and 2-g Fortaz (Ceftazidime) 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 12 hours at room temperature or for 3 days under refrigeration.
Fortaz (Ceftazidime) is less stable in Sodium Bicarbonate Injection than in other IV fluids. It is not recommended as a diluent. Solutions of Fortaz (Ceftazidime) in 5% Dextrose Injection and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers, and volume control devices of common IV infusion sets.
Ceftazidime at a concentration of 4 mg/mL has been found compatible for 12 hours at room temperature or for 3 days under refrigeration in 0.9% Sodium Chloride Injection or 5% Dextrose Injection when admixed with: cefuroxime sodium (ZINACEF) 3 mg/mL, heparin 10 or 50 U/mL, or potassium chloride 10 or 40 mEq/L.
Vancomycin solution exhibits a physical incompatibility when mixed with a number of drugs, including ceftazidime. The likelihood of precipitation with ceftazidime is dependent on the concentrations of vancomycin and ceftazidime present. It is therefore recommended, when both drugs are to be administered by intermittent IV infusion, that they be given separately, flushing the IV lines (with 1 of the compatible IV fluids) between the administration of these 2 agents.
Note:
As with other cephalosporins, Fortaz (Ceftazidime) powder, as well as solutions, tend to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.
Fortaz (Ceftazidime) How Supplied
Fortaz (Ceftazidime) in the dry state should be stored between 15° and 30°C (59° and 86°F) and protected from light. Fortaz (Ceftazidime) is a dry, white to off-white powder supplied in vials as follows:
NDC 0173-0377-10 500-mg Vial (Tray of 10)
NDC 0173-0378-10 1-g Vial (Tray of 10)
NDC 0173-0379-34 2-g Vial (Tray of 10)
NDC 0173-0382-37 6-g Pharmacy Bulk Package (Tray of 6)
NDC 0173-0434-00 1-g ADD-Vantage Vial (Tray of 25)
NDC 0173-0435-00 2-g ADD-Vantage Vial (Tray of 10)
(The above ADD-Vantage vials are to be used only with Abbott ADD-Vantage diluent containers.)
Fortaz (Ceftazidime) frozen as a premixed solution of ceftazidime sodium should not be stored above -20°C. Fortaz (Ceftazidime) is supplied frozen in 50-mL, single-dose, plastic containers as follows:
NDC 0173-0412-00 1-g Plastic Container (Carton of 24)
NDC 0173-0413-00 2-g Plastic Container (Carton of 24)
Fortaz (Ceftazidime) References
GlaxoSmithKline
Fortaz (Ceftazidime) (ceftazidime for injection):
GlaxoSmithKline
Research Triangle Park, NC 27709
Fortaz (Ceftazidime) (ceftazidime injection):
Manufactured for GlaxoSmithKline
Research Triangle Park, NC 27709
by Baxter Healthcare Corporation
Deerfield, IL 60015
Fortaz (Ceftazidime) and ZINACEF are registered trademarks of GlaxoSmithKline.
ADD-Vantage is a registered trademark of Hospira, Inc.
CLINITEST and CLINISTIX are registered trademarks of Ames Division, Miles Laboratories, Inc.
GALAXY and VIAFLEX are registered trademarks of Baxter International Inc.
August 2010 FTZ:1PI
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
TEAR AWAY
Peel the corner of the ADD-Vantage diluent overwrap and remove flexible diluent container. Some opacity of the plastic flexible container 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.
1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see Figure 1), then pull straight up to remove the cap (see Figure 2).
b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover (see Figure 3).
2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately one-half turn (180°) after the first audible click (see Figure 4). The clicking sound does not assure a seal; the vial must be turned as far as it will go.
3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.
4. Label appropriately.
1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.
2. With the other hand, push the drug vial down into the container, telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container (see Figure 5).
3. Pull the inner cap from the drug vial (see Figure 6). Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.
4. Mix container contents thoroughly and use within the specified time.
1. Confirm the activation and admixture of vial contents.
2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.
3. Close flow control clamp of administration set.
4. Remove cover from outlet port at bottom of container.
5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.
7. Squeeze and release drip chamber to establish proper fluid level in chamber.
8. Open flow control clamp and clear air from set. Close clamp.
9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
10. Regulate rate of administration with flow control clamp.
1. Insert the syringe needle through the vial closure and inject 26 mL of diluent. The vacuum may assist entry of the diluent. Remove the syringe needle.
2. Shake to dissolve; a clear solution containing approximately 1 g of ceftazidime activity per 5 mL will be obtained in 1 to 2 minutes.
3. Insert a gas-relief needle through the vial closure to relieve the internal pressure. Remove the gas-relief needle before extracting any solution.
GlaxoSmithKline
Research Triangle Park, NC 27709
August 2010 FTZ:1DIR
Fortaz (Ceftazidime) Principal Display Panel
See prescribing information for Dosage and Administration. Before constitution, store between 15 and 30C (59 and 86F) and protect from light.
GlaxoSmithKline, RTP, NC 27709
Made in England
10000000039211
Rev. 4/07
Fortaz (Ceftazidime) Principal Display Panel
See prescribing information for Dosage and Administration. Before constitution, store between 15 and 30C (59 and 86F) and protect from light.
GlaxoSmithKline, RTP, NC 27709
Made in England
Rev. 2/07
10000000039151
Fortaz (Ceftazidime) Principal Display Panel
See prescribing information for Dosage and Administration. Before constitution, store between 15 and 30C (59 and 86F) and protect from light.
GlaxoSmithKline, RTP, NC 27709
Made in England
Rev. 2/07
10000000039155
Fortaz (Ceftazidime) Principal Display Panel
See package insert for Dosage and Administration. Before constitution, store between 15 and 30C (59 and 86F) and protect from light.
To prepare solution, add 26 mL of Sterile Water for Injection. Shake well to dissolve. The constituted solution occupies a volume of about 31.5 mL and contains approximately 1 g of ceftazidime activity per 5 mL.
After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25C [77F]) or for 3 days under refrigeration. Color changes do not affect potency. This vial contains 709 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq) per gram of ceftazidime.
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in England
10000000057527
Rev. 6/08
Fortaz (Ceftazidime) Principal Display Panel
See prescribing information for Dosage and Administration and Instructions for Constitution.
Before constitution, store between 15 and 30C (59 and 86F) and protect from light.
Color changes do not affect potency. This vial contains 118 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq).
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in England
Rev. 8/10
*ADD-Vantage is a trademark of Hospira, Inc
10000000082798
Fortaz (Ceftazidime) Principal Display Panel
See prescribing information for Dosage and Administration and Instructions for Constitution.
Before constitution, store between 15 and 30C (59 and 86F) and protect from light.
Color changes do not affect potency. This vial contains 236 mg of sodium carbonate. The sodium content is approximately 108 mg (4.7 mEq).
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in England
Rev. 8/10
*ADD-Vantage is a trademark of Hospira, Inc
10000000082821
Fortaz (Ceftazidime) Principal Display Panel
Each 50 mL contains: ceftazidime sodium equivalent to 1 g of ceftazidime with approx. 2.2 g of Dextrose Hydrous, USP added to adjust osmolality. pH adjusted with sodium hydroxide and may have been adjusted with hydrochloric acid. pH 5.0 to 7.5.
Dosage: Intravenously as directed by a physician. See prescribing information. Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.
Do not store above -20C. Thaw at room temperature (25C) or under refrigeration (5C). Thawed solution is stable for 3 days under refrigeration or 8 hours at room temperature.
Fortaz (Ceftazidime) is a registered trademark of GlaxoSmithKline
GALAXY is a trademark of Baxter International Inc.
Manufactured for
Research Triangle Park, NC 27709
by , Deerfield, IL 60015 USA
Made in England
PL 2040 Plastic
10000000091386
07-34-65-877
Rev. 2/11
Fortaz (Ceftazidime) Principal Display Panel
Each 50 mL contains: ceftazidime sodium equivalent to 2 g of ceftazidime with approx. 1.6 g of Dextrose Hydrous, USP added to adjust osmolality. pH adjusted with sodium hydroxide and may have been adjusted with hydrochloric acid. pH 5.0 to 7.5.
Dosage: Intravenously as directed by a physician. See prescribing information. Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.
Do not store above -20C. Thaw at room temperature (25C) or under refrigeration (5C). Thawed solution is stable for 3 days under refrigeration or 8 hours at room temperature.
Fortaz (Ceftazidime) is a registered trademark of GlaxoSmithKline
GALAXY is a trademark of Baxter International Inc.
Manufactured for
Research Triangle Park, NC 27709
by , Deerfield, IL 60015 USA
Made in England
PL 2040 Plastic
10000000091387
07-34-65-878
Rev. 2/11
