Ceftazidime

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CEFTAZIDIME (CEFTAZIDIME)

Composition:

Active substance: ceftazidime;

1 vial contains ceftazidime (as ceftazidime pentahydrate) 1.0 g;

Excipient: sodium carbonate.

Pharmaceutical form. Powder for solution for injection.

Main physicochemical properties: white or pale-yellow powder.

Pharmacotherapeutic group. Antibacterials for systemic use. Beta-lactam antibiotics. Third-generation cephalosporins.

ATC code J01D D02.

Pharmacological Properties

Pharmacodynamics

Ceftazidime is a bactericidal cephalosporin antibiotic whose mechanism of action is related to inhibition of bacterial cell wall synthesis.

Acquired resistance to the antibiotic varies across different regions and may change over time, with significant differences possible among individual strains. It is advisable to consult local data on antibiotic susceptibility and prevalence of beta-lactamase-producing microorganisms with extended-spectrum activity, especially when treating severe infections.

Susceptible microorganisms

Gram-positive aerobes: Streptococcus pyogenes, Streptococcus agalactiae.

Gram-negative aerobes: Citrobacter koseri, Haemophilus influenzae, Moraxella catarrhalis, Neisseria meningitidis, Proteus mirabilis, Proteus spp., Providencia spp., Pasteurella multocida.

Strains with possible acquired resistance

Gram-negative aerobes: Acinetobacter baumannii, Burkholderia cepacia, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Klebsiella spp., Pseudomonas aeruginosa, Serratia spp., Morganella morganii.

Gram-positive aerobes: Staphylococcus aureus, Streptococcus pneumoniae, Viridans group streptococci.

Gram-positive anaerobes: Clostridium perfringens, Peptococcus spp., Peptostreptococcus spp.

Gram-negative anaerobes: Fusobacterium spp.

Resistant microorganisms

Gram-positive aerobes: Enterococcus spp., including E. faecalis and E. faecium, Listeria spp.

Gram-positive anaerobes: Clostridium difficile.

Gram-negative anaerobes: Bacteroides spp., including B. fragilis.

Others: Chlamydia spp., Mycoplasma spp., Legionella spp.

Pharmacokinetics

In patients, after intramuscular injection of 500 mg and 1 g, mean peak concentrations of 18 and 37 mg/L, respectively, are rapidly achieved. Five minutes after intravenous bolus administration of 500 mg, 1 g, or 2 g, mean serum concentrations of 46, 87, or 170 mg/L, respectively, are achieved. Therapeutically effective concentrations persist in serum for up to 8–12 hours after both intravenous and intramuscular administration. Plasma protein binding is approximately 10%. Concentrations of ceftazidime exceeding the minimum inhibitory concentration (MIC) for most common pathogenic microorganisms are achieved in tissues and body fluids such as bone, heart, bile, sputum, intraocular fluid, synovial fluid, pleural fluid, and peritoneal fluid. Ceftazidime rapidly crosses the placenta and is excreted into breast milk. The drug poorly penetrates the intact blood-brain barrier; in the absence of inflammation, CNS concentrations are low. However, during meningitis, ceftazidime concentrations in the CNS reach 4–20 mg/L or higher, which corresponds to therapeutic levels.

Ceftazidime is not metabolized in the body. After parenteral administration, high and sustained serum concentrations of ceftazidime are achieved. The elimination half-life is approximately 2 hours. The drug is excreted unchanged and in active form in urine via glomerular filtration; approximately 80–90% of the dose is recovered in urine within 24 hours. In patients with impaired renal function, elimination of ceftazidime is reduced, and dosage adjustment is required. Less than 1% of the drug is excreted in bile, significantly limiting the amount reaching the intestinal tract.

Clinical characteristics.

Indications.

Treatment of the following infections in adults and children, including newborns:

• hospital-acquired pneumonia;
• respiratory tract infections in patients with cystic fibrosis;
• bacterial meningitis;
• chronic suppurative otitis media;
• malignant external otitis;
• complicated urinary tract infections;
• complicated skin and soft tissue infections;
• complicated intra-abdominal infections;
• bone and joint infections;
• peritonitis associated with dialysis in patients undergoing continuous ambulatory peritoneal dialysis.

Treatment of bacteremia arising in patients as a result of any of the above-mentioned infections.

Ceftazidime may be used for the treatment of patients with neutropenia and fever due to bacterial infection.

Ceftazidime may be used for prophylaxis of urinary tract infections in urological procedures (transurethral resection of the prostate).

When prescribing ceftazidime, consideration should be given to its antibacterial spectrum, which is primarily directed against Gram-negative aerobes (see sections «Special precautions» and «Pharmacological properties»).

Ceftazidime should be used in combination with other antibacterial agents if it is expected that some of the microorganisms causing the infection are not covered by the spectrum of ceftazidime.

The drug should be prescribed in accordance with current official guidelines for the use of antibacterial agents.

Contraindications.

Hypersensitivity to ceftazidime or to any of the excipients of the drug.

Hypersensitivity to other cephalosporin antibiotics.

History of severe hypersensitivity (e.g., anaphylactic reactions) to other beta-lactam antibiotics (penicillins, monobactams, and carbapenems).

Interaction with other medicinal products and other forms of interaction.

Concomitant use of high doses of the drug with nephrotoxic medicinal products may adversely affect renal function (see section «Special precautions»).

Chloramphenicol in vitro is an antagonist of ceftazidime and other cephalosporins. The clinical significance of this phenomenon is unknown; however, if concomitant administration of Ceftazidime with chloramphenicol is proposed, the possibility of antagonism should be considered.

Like other antibiotics, Ceftazidime may affect intestinal flora, leading to reduced reabsorption of estrogens and decreased effectiveness of combined oral contraceptives.

Ceftazidime does not interfere with enzymatic methods for glucose in urine; however, a slight interference may occur with copper reduction methods (Benedict's, Fehling's, Clinitest).

Ceftazidime does not interfere with the alkaline picrate method for creatinine determination.

Special precautions for use

As with other beta-lactam antibiotics, severe and occasionally fatal hypersensitivity reactions have been reported. If severe hypersensitivity reactions occur, ceftazidime therapy must be discontinued immediately and appropriate emergency measures initiated.

Prior to starting therapy, patients should be questioned about previous hypersensitivity reactions to ceftazidime, cephalosporin antibiotics, or other beta-lactam antibiotics. The drug should be administered with caution to patients who have experienced mild hypersensitivity reactions to other beta-lactam antibiotics.

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with ceftazidime. These reactions, which may be life-threatening or fatal, occur at an unknown frequency.

Patients should be informed about the signs and symptoms of these reactions, and closely monitored for skin-related adverse effects.

If signs or symptoms suggestive of such reactions occur, ceftazidime must be discontinued immediately, and alternative therapy considered.

If a serious reaction such as SJS, TEN, DRESS, or AGEP develops during ceftazidime treatment, ceftazidime therapy must not be restarted under any circumstances.

Ceftazidime has a limited antibacterial spectrum. It is not an appropriate agent for monotherapy of certain types of infections unless it has been established that the causative pathogen is susceptible to ceftazidime, or there is a high likelihood that the likely pathogen will be susceptible. This is particularly important when considering treatment of patients with bacteremia, bacterial meningitis, skin and soft tissue infections, and bone and joint infections. Furthermore, ceftazidime is susceptible to hydrolysis by certain extended-spectrum beta-lactamases. Therefore, when selecting ceftazidime for treatment, information regarding the prevalence of microorganisms producing extended-spectrum beta-lactamases should be taken into account.

Concomitant administration of high doses of cephalosporins and nephrotoxic agents, such as aminoglycosides or potent diuretics (e.g., furosemide), may adversely affect renal function. Clinical experience with ceftazidime has shown that this phenomenon is unlikely when the recommended dosage is followed. There are no data indicating that ceftazidime adversely affects renal function at normal therapeutic doses.

Ceftazidime is eliminated by the kidneys; therefore, the dose should be adjusted according to the degree of renal impairment. Cases of neurological complications have been reported when the dose was not appropriately reduced (see sections "Dosage and administration" and "Side effects").

As with other broad-spectrum antibiotics, prolonged treatment with ceftazidime may result in overgrowth of non-susceptible microorganisms (e.g., Candida, Enterococci). In such cases, discontinuation of therapy or other necessary measures may be required. Close monitoring of the patient is essential.

Cases of pseudomembranous colitis, ranging in severity from mild to life-threatening, have been reported with antibiotic use. Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after antibiotic therapy. If prolonged or significant diarrhea occurs, or if abdominal cramps develop, treatment should be discontinued immediately, further diagnostic evaluation performed, and specific therapy for Clostridium difficile initiated as needed. Medicinal products that inhibit intestinal peristalsis should not be administered.

As with other broad-spectrum cephalosporins and penicillins, some previously susceptible strains of Enterobacter spp. and Serratia spp. may become resistant during ceftazidime therapy. In such cases, periodic susceptibility testing should be performed.

The product contains approximately 50 mg of sodium per 1 g of ceftazidime. This should be taken into consideration for patients on sodium-restricted diets.

Use during pregnancy or breastfeeding

Data on ceftazidime use in pregnant women are limited. Animal studies do not indicate any direct or indirect harmful effects on pregnancy, embryonal or fetal development, or postnatal development. Ceftazidime should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ceftazidime is excreted in human milk in small amounts, but no effects on the breastfed infant are expected with therapeutic doses. Ceftazidime may be used during breastfeeding.

Effect on ability to drive and use machines

No specific studies have been conducted. However, certain side effects (e.g., dizziness) may occur, which could affect the ability to drive or operate machinery (see section "Side effects").

Administration and dosage.

Ceftazidime should be administered parenterally. The dose depends on the severity of the disease, sensitivity, localization and type of infection, as well as on the patient's body weight and renal function. A skin test for tolerance should be performed before administration of the drug!

Adults and children ≥40 kg

Table 1

Intermittent administration
Infection	Dose administered
respiratory tract infections in patients with cystic fibrosis	100–150 mg/kg body weight/day every 8 hours, up to a maximum of 9 g per day1
febrile neutropenia	2 g every 8 hours
hospital-acquired pneumonia
bacterial meningitis
bacteremia*
bone and joint infections	1–2 g every 8 hours
complicated skin and soft tissue infections
complicated intra-abdominal infections
peritonitis associated with continuous ambulatory peritoneal dialysis
complicated urinary tract infections	1–2 g every 8 or 12 hours
prophylaxis of postoperative infections in urological surgery (transurethral resection)	1 g at the time of induction of anesthesia, and a second dose at the time of catheter removal
chronic suppurative otitis media	1–2 g every 8 hours
malignant external otitis
Continuous infusion
Infection	Dose administered
febrile neutropenia	A loading dose of 2 g is administered, followed by continuous infusion of 4 to 6 g every 24 hours1
hospital-acquired pneumonia
respiratory tract infections in patients with cystic fibrosis
bacterial meningitis
bacteremia*
bone and joint infections
complicated skin and soft tissue infections
complicated intra-abdominal infections
peritonitis associated with continuous ambulatory peritoneal dialysis
1 In adult patients with normal renal function, 9 g per day has been administered without adverse reactions.

Children <40 kg

Table 2

Infants and children >2 months of age and body weight <40 kg	Infection	Usual dose
Intermittent administration
	complicated urinary tract infections	100–150 mg/kg body weight/day in 3 divided doses, maximum 6 g/day
	chronic otitis media
	malignant external otitis
	neutropenia in children	150 mg/kg body weight/day in 3 divided doses, maximum 6 g/day
	respiratory tract infections in patients with cystic fibrosis
	bacterial meningitis
	bacteraemia*
	bone and joint infections	100–150 mg/kg body weight/day in 3 divided doses, maximum 6 g/day
	complicated skin and soft tissue infections
	complicated intra-abdominal infections
	peritonitis associated with continuous ambulatory peritoneal dialysis
Continuous infusion
	febrile neutropenia	A loading dose of 60–100 mg/kg body weight is administered, followed by continuous infusion of 100–200 mg/kg body weight/day, up to a maximum of 6 g/day
	hospital-acquired pneumonia
	respiratory tract infections in patients with cystic fibrosis
	bacterial meningitis
	bacteraemia*
	bone and joint infections
	complicated skin and soft tissue infections
	complicated intra-abdominal infections
	peritonitis associated with continuous ambulatory peritoneal dialysis
Infants and children ≤2 months of age	Infection	Usual dose
Intermittent administration
	Most infections	25–60 mg/kg body weight/day in 2 divided doses1
1 In infants and children ≤2 months of age, the serum half-life may be 2–3 times longer than in adults

* if this is associated or suspected to be associated with infections listed in the section "Indications".

Children.

The safety and efficacy of administering Ceftazidime by continuous intravenous infusion in infants and children ≤2 months of age have not been established.

Geriatric patients.

Due to reduced ceftazidime clearance, for elderly patients with acute infections, the daily dose generally should not exceed 3 g, especially in patients aged 80 years and older.

Hepatic impairment.

Dosage adjustment is not required for patients with mild to moderate hepatic impairment. Clinical studies in patients with severe hepatic impairment have not been conducted. Careful clinical monitoring of efficacy and safety is recommended.

Renal impairment.

Ceftazidime is eliminated unchanged by the kidneys. Therefore, the dose should be reduced in patients with impaired renal function.

The initial loading dose should be 1 g. The maintenance dose should be based on creatinine clearance.

Recommended maintenance doses of ceftazidime in renal impairment – intermittent administration

Adults and children ≥40 kg body weight

Table 3

Creatinine clearance, mL/min	Approximate serum creatinine level, µmol/L (mg/dL)	Recommended single dose of ceftazidime, g	Dosing interval (hours)
50-31	150-200 (1.7-2.3)	1	12
30-16	200-350 (2.3-4)	1	24
15-6	350-500 (4-5.6)	0.5	24
<5	>500 (>5.6)	0.5	48

For patients with severe infections, the single dose may be increased by 50% or the frequency of administration correspondingly increased. Serum ceftazidime levels should be monitored in such patients.

In children, creatinine clearance should be adjusted according to body surface area or body weight.

Children <40 kg

Table 4

Creatinine clearance, ml/min**	Approximate serum creatinine level*, μmol/L (mg/dL)	Recommended individual dose mg/kg body weight	Dosing frequency (hours)
50-31	150-200 (1.7-2.3)	25	12
30-16	200-350 (2.3-4)	25	24
15-6	350-500 (4-5.6)	12.5	24
<5	>500 (>5.6)	12.5	48

* this is the serum creatinine level calculated according to recommendations and may not precisely correspond to the degree of renal function impairment in all patients with renal insufficiency.

** creatinine clearance calculated based on body surface area, or measured.

Careful clinical monitoring of efficacy and safety of administration is recommended.

Recommended maintenance doses of ceftazidime in renal insufficiency – continuous infusion

Adults and children ≥40 kg body weight

Table 5

Creatinine clearance, mL/min	Approximate serum creatinine level, µmol/L (mg/dL)	Dosing frequency (hours)
50-31	150-200 (1.7-2.3)	A loading dose of 2 g is administered, followed by continuous infusion of 1 to 3 g every 24 hours
30-16	200-350 (2.3-4)	A loading dose of 2 g is administered, followed by continuous infusion of 1 g every 24 hours
≤15	>350 (>4)	Not studied

Dose selection should be cautious. Careful clinical monitoring of efficacy and safety of use is recommended.

Children <40 kg. Safety and efficacy of administering Ceftazidime by continuous intravenous infusion to children with impaired renal function whose body weight is <40 kg have not been established. Careful clinical monitoring of efficacy and safety of use is recommended.

If continuous intravenous infusion of the drug is required in children with impaired renal function, creatinine clearance should be adjusted according to the child's body surface area or body weight.

Hemodialysis.

The serum half-life of ceftazidime during hemodialysis is 3 to 5 hours.

A maintenance dose of ceftazidime, as recommended in the table below, should be administered after each hemodialysis session.

Peritoneal dialysis.

Ceftazidime can be used during peritoneal dialysis, including continuous ambulatory peritoneal dialysis (CAPD).

In addition to intravenous administration, ceftazidime may be added to the dialysis fluid (usually 125 to 250 mg per 2 L of dialysis solution).

For patients with renal impairment undergoing prolonged arteriovenous hemodialysis or high-flux hemofiltration in intensive care units, the recommended dose is 1 g daily as a single dose or divided doses. For low-flux hemofiltration, doses should be adjusted as in renal dysfunction.

For patients undergoing venovenous hemofiltration and venovenous hemodialysis, dosage recommendations are provided in the tables below.

Dosing recommendations for ceftazidime in patients undergoing prolonged venovenous hemofiltration

Table 6

Residual renal function (creatinine clearance, ml/min)	Maintenance dose (mg) according to ultrafiltration rate (ml/min) a
	5	16.7	33.3	50
0	250	250	500	500
5	250	250	500	500
10	250	500	500	750
15	250	500	500	750
20	500	500	500	750

The maintenance dose should be administered every 12 hours.

Dosage recommendations for ceftazidime in patients undergoing prolonged venovenous hemodialysis

Table 7

Residual renal function (creatinine clearance, ml/min)	Supplementary dose (mg) for dialysate at flow rate (ml/min) a
	1 l/h			2 l/h
	Ultrafiltration rate (l/h)			Ultrafiltration rate (l/h)
	0.5	1	2	0.5	1	2
0	500	500	500	500	500	750
5	500	500	750	500	500	750
10	500	500	750	500	750	1000
15	500	750	750	750	750	1000
20	750	750	1000	750	750	1000

The maintenance dose should be administered every 12 hours.

Administration.

Ceftazidime should be administered intravenously by injection or infusion, or by deep intramuscular injection. Recommended sites for intramuscular administration are the upper outer quadrant of the gluteus maximus muscle or the lateral part of the thigh.

Ceftazidime solutions may be administered directly into the vein or into an intravenous infusion system if the patient is receiving parenteral fluids.

The dosage depends on the severity of the infection, the susceptibility, site, and type of infection, as well as the patient's age and renal function.

Antibiotic resistance varies among different regions and may change over time, with significant differences observed even among individual strains. It is advisable to use local data on antibiotic susceptibility, especially when treating severe infections.

Preparation of solution.

Ceftazidime is compatible with commonly used intravenous infusion solutions. However, sodium bicarbonate for injection should not be used as a solvent (see section "Incompatibilities").

All vial sizes are manufactured under reduced pressure. As the drug dissolves, carbon dioxide is released and pressure within the vial increases. Small bubbles of carbon dioxide in the reconstituted solution can be disregarded.

Reconstitution instructions: see Table 8.

Table 8

Flacon volume	Route of administration	Required amount of solvent (ml)	Approximate concentration (mg/ml)
1 g	intramuscular intravenous bolus intravenous infusion	3 10 50*	260 90 20

The solution for intravenous infusion should be prepared in two steps (see below in the text).

The color of the solution varies from bright yellow to amber depending on the concentration, solvent, and storage conditions. If the recommendations are followed, the drug's efficacy is not affected by variations in its coloration.

Ceftazidime at concentrations from 1 mg/mL to 40 mg/mL is compatible with the following solutions: 0.9% sodium chloride solution; M/6 sodium lactate solution; Hartmann's solution; 5% glucose solution, 0.225% sodium chloride and 5% glucose solution; 0.45% sodium chloride and 5% glucose solution; 0.9% sodium chloride and 5% glucose solution; 0.18% sodium chloride and 4% glucose solution; 10% glucose solution; 10% glucose 40 and 0.9% sodium chloride solution; 10% glucose 40 and 5% glucose solution; 6% dextran 70 and 0.9% sodium chloride solution; 6% dextran 70 and 5% glucose solution.

Ceftazidime at concentrations from 0.05 mg/mL to 0.25 mg/mL is compatible with intraperitoneal dialysis fluid (lactate).

For intramuscular administration, ceftazidime may be reconstituted with 0.5% or 1% lidocaine hydrochloride solution.

The efficacy of both drugs is maintained when ceftazidime at a concentration of 4 mg/mL is mixed with the following substances: hydrocortisone (hydrocortisone sodium phosphate) 1 mg/mL in 0.9% sodium chloride injection or 0.5% glucose solution; cefuroxime (cefuroxime sodium) 3 mg/mL in 0.9% sodium chloride injection; cloxacillin (cloxacillin sodium) 4 mg/mL in 0.9% sodium chloride injection; heparin 10 IU/mL or 50 IU/mL in 0.9% sodium chloride injection; potassium chloride 10 mEq/L or 40 mEq/L in 0.9% sodium chloride injection.

Ceftazidime reconstituted with lidocaine must not be used:

• for intravenous administration;
• in children under 12 years of age;
• in patients with hypersensitivity to lidocaine;
• in patients with heart block;
• in patients with severe heart failure.

Preparation of the solution for intramuscular or intravenous bolus injection.

1. Insert the needle of the syringe through the stopper of the vial and inject the recommended volume of diluent.
2. Remove the syringe needle and shake the vial until a clear solution is obtained.
3. Invert the vial. With the plunger fully depressed, insert the needle into the vial. Withdraw the entire solution into the syringe, keeping the needle immersed in the solution at all times. Small bubbles of carbon dioxide may be disregarded.

Preparation of the solution for intravenous infusion in 2 steps.

1. Insert the needle of the syringe through the stopper of the vial and inject 10 mL of diluent.
2. Remove the syringe needle and shake the vial until a clear solution is obtained.
3. Do not insert the air vent needle through the stopper until the drug is completely dissolved. Insert the air vent needle through the stopper into the vial to relieve internal pressure.
4. Add the resulting solution to an intravenous infusion system so that the total volume of the solution is at least 50 mL, and administer by intravenous infusion over 15–30 minutes.

Note. To ensure sterility of the preparation, it is very important not to insert the needle through the stopper before the drug is completely dissolved.

The prepared solution may be stored for up to 24 hours at a temperature below 25 °C.

Children.

May be used in children from the first days of life.

Overdose.

Overdose may lead to neurological complications such as encephalopathy, seizures, and coma. Symptoms of overdose may occur in patients with renal impairment if the dose is not appropriately reduced (see sections "Dosage and Administration" and "Special Warnings and Precautions").

Plasma concentrations of ceftazidime can be reduced by hemodialysis or peritoneal dialysis.

Treatment: symptomatic.

Adverse Reactions

Adverse effects are classified according to their frequency of occurrence — from very common to uncommon, and by organ systems: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1000 to <1/100; rare ≥1/10,000 to <1/1000; very rare <1/10,000; frequency not known.

Infections and infestations

Uncommon – candidiasis (including vaginitis and candidal stomatitis).

Blood and lymphatic system disorders

Common – eosinophilia and thrombocytosis.
Uncommon – leukopenia, neutropenia, and thrombocytopenia.
Frequency not known – lymphocytosis, hemolytic anemia, agranulocytosis.

Immune system disorders

Frequency not known – anaphylaxis (including bronchospasm and/or arterial hypotension).

Nervous system disorders

Uncommon – dizziness, headache.
Frequency not known – paresthesia.

Cases of neurological complications such as tremor, myoclonia, seizures, encephalopathy, and coma have been reported in patients with renal impairment who did not receive appropriate dose reduction of ceftazidime.

Vascular disorders

Common – phlebitis or thrombophlebitis at the site of injection.

Gastrointestinal disorders

Common – diarrhea.
Uncommon – nausea, vomiting, abdominal pain, and colitis.

As with other cephalosporins, colitis may be related to Clostridium difficile and may present as pseudomembranous colitis (see section "Special precautions").

Frequency not known – taste disturbances.

Renal and urinary disorders

Uncommon – transient increase in blood urea levels.
Very rare – interstitial nephritis, acute renal failure.

Hepatobiliary disorders

Common – transient elevation of one or more liver enzymes (ALT, AST, LDH, GGT, alkaline phosphatase).
Frequency not known – jaundice.

Skin and subcutaneous tissue disorders

Common – maculopapular rash or urticaria.
Uncommon – pruritus.
Frequency not known – angioneurotic edema, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP).

General disorders and administration site conditions

Common – pain and/or inflammation at the site of intramuscular injection.
Uncommon – fever.

Laboratory findings

Common – positive Coombs test.
Uncommon – as with some other cephalosporins, transient increases in blood urea, blood urea nitrogen, and/or serum creatinine have occasionally been observed.

A positive Coombs test occurs in approximately 5% of patients and may interfere with blood grouping.

Shelf life.

Ceftazidime, powder for solution for injection 1.0 g – 2 years.
Water for injections, solvent for parenteral use, 10 ml in ampoule – 4 years.
The shelf life of the final preparation is determined by the component (powder or solvent) with the shorter expiration date.

Storage conditions. Store in a place inaccessible to children, in the original packaging, at a temperature not exceeding 25 °C.

Incompatibilities.

Ceftazidime is less stable in solutions of sodium bicarbonate for injection than in other intravenous solutions. Therefore, sodium bicarbonate is not recommended as a solvent.

Ceftazidime and aminoglycosides should not be mixed in the same infusion system or syringe.

Precipitation may occur when vancomycin solution is added to ceftazidime solution; therefore, infusion systems and intravenous catheters should be flushed between administration of these agents.

Packaging. 1 g of powder in a vial; 1, 5, or 50 vials per carton; or 1 or 5 vials in a blister pack, 1 blister per carton; 1 vial and 1 ampoule of solvent (water for injections, 10 ml per ampoule) in a blister pack, 1 blister per carton.

Prescription category. Prescription only.

Manufacturer. Private Joint-Stock Company "Lekhim-Kharkiv". LLC "Lekhim-Obukhiv".

Manufacturing and bulk packaging by the manufacturer company Quilu Pharmaceutical Co., Ltd., China.

Manufacturer's address and location of business activity.

Ukraine, 61115, Kharkiv region, Kharkiv, Severina Pototskogo St., 36.
Ukraine, 08700, Kyiv region, Obukhiv, Kyivska St., 126 A.