Cefixime

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

Composition:

Active substance: ceftazidime;

1 vial contains ceftazidime (in the form of ceftazidime pentahydrate) 1 g;

Excipient: sodium carbonate.

Pharmaceutical form. Powder for solution for injection or infusion.

Main physicochemical properties: white or pale yellow powder in vials.

Pharmacotherapeutic group.

Antibacterial agents for systemic use. Third-generation cephalosporins.

ATC code J01D D02.

Pharmacological properties.

Pharmacodynamics.

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

Acquired resistance to the antibiotic varies across different regions and may change over time, and can significantly differ among individual strains. It is advisable to use local data on antibiotic susceptibility and information on the 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, Staphylococcus pneumoniae, Viridans group streptococci.

Gram-positive anaerobes: Clostridium perfringens, 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.

Absorption

After intramuscular injection of 500 mg and 1 g, peak mean serum concentrations of 18 and 37 mg/L, respectively, are rapidly achieved in patients. Within 5 minutes after intravenous bolus administration of 500 mg, 1 g, or 2 g, serum concentrations reach on average 46, 87, or 170 mg/L, respectively. Therapeutically effective concentrations persist in serum even 8–12 hours after intravenous and intramuscular administration.

Distribution

Plasma protein binding is approximately 10%. Therapeutic concentrations of ceftazidime exceeding the minimum inhibitory concentration 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 penetrates across the placenta and into breast milk. The drug poorly penetrates the intact blood-brain barrier; in the absence of inflammation, concentrations in the central nervous system (CNS) are low. However, during meningitis, CNS concentrations of ceftazidime range from 4 to 20 mg/L or higher, which corresponds to therapeutic levels.

Biotransformation

Ceftazidime is not metabolized in the body.

Elimination

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, in active form, in urine via glomerular filtration; about 80–90% of the dose is eliminated in urine within 24 hours. Less than 1% of the drug is excreted in bile, significantly limiting the amount of drug reaching the intestinal tract.

Special patient groups

Renal impairment

In patients with impaired renal function, elimination of ceftazidime is reduced; therefore, the dose should be adjusted.

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 treatment of patients with neutropenia and fever resulting from bacterial infection.

Ceftazidime may be used for prophylaxis of urinary tract infections during prostate surgery (transurethral resection).

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

Ceftazidime should be administered 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.

Prescribing of the medicinal product should follow official recommendations for the use of antibacterial agents.

Contraindications.

Hypersensitivity to ceftazidime or to any of the excipients of the medicinal product.

Hypersensitivity to 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.

Interaction studies have been conducted only with probenecid and furosemide.

Concomitant administration of high doses of the medicinal product with nephrotoxic medicinal products may adversely affect renal function (see section "Special precautions for use").

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 efficacy of combined oral contraceptives.

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

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

Special precautions for use.

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

Prior to initiating 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 skin adverse reactions (SSARs), 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 result in fatal outcomes, occur at an unknown frequency.

Patients should be informed about the signs and symptoms and closely monitored for skin reactions.

If signs or symptoms suggesting these reactions occur, ceftazidime should be discontinued immediately and alternative therapy considered.

If a patient develops a serious reaction such as SJS, TEN, DRESS, or AGEP while receiving ceftazidime, ceftazidime therapy must never be restarted.

Antimicrobial spectrum

Ceftazidime has a limited spectrum of antibacterial activity. It is not an appropriate agent for monotherapy of certain types of infections unless the causative pathogen has been shown to be susceptible to ceftazidime, or there is a high probability that likely pathogens will be susceptible. This is particularly important to consider when treating patients with bacteremia, bacterial meningitis, skin and soft tissue infections, and bone and joint infections. Additionally, ceftazidime is susceptible to hydrolysis by certain extended-spectrum beta-lactamases (ESBLs). Therefore, when selecting ceftazidime for therapy, local information regarding the prevalence of microorganisms producing extended-spectrum beta-lactamases should be taken into account.

Renal function

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 indicates that this is unlikely when recommended dosages are followed. There are no data indicating that ceftazidime adversely affects renal function at usual therapeutic doses.

Ceftazidime is eliminated by the kidneys; therefore, dosage adjustment is necessary according to the degree of renal impairment. Cases of neurological complications have been reported when dosage was not appropriately reduced (see sections “Dosage and administration” and “Adverse reactions”).

Overgrowth of non-susceptible organisms

As with other broad-spectrum antibiotics, prolonged use of ceftazidime may result in overgrowth of non-susceptible microorganisms (e.g., Candida, Enterococci). In such cases, discontinuation of therapy or other appropriate measures may be necessary. It is essential to monitor the patient’s condition continuously.

Pseudomembranous colitis

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

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.

Testing and interaction analysis

Ceftazidime does not interfere with enzymatic tests for glucosuria. However, a minor effect (false-positive results) may occur with copper reduction methods (Benedict, Fehling, Clinitest).

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

Development of a positive direct Coombs test, associated with ceftazidime use, occurs in approximately 5% of patients and may interfere with cross-matching of blood.

The product contains sodium (one vial containing 1 g of ceftazidime contains 54 mg [2.3 mmol] of sodium, equivalent to 2.7% of the maximum daily intake of 2 g for adults as recommended by WHO).

Use during pregnancy or breastfeeding.

Data on ceftazidime use in pregnant women are limited. The drug 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 effect on the breastfed infant is expected with therapeutic doses. Ceftazidime may be used during breastfeeding.

Ability to influence the ability to drive or operate machinery.

No specific studies have been conducted. However, adverse reactions such as dizziness may affect the ability to drive or operate machinery.

Method of administration and dosage.

Adults and children with body weight ≥ 40 kg

Intermittent administration
Infection	Dose administered
respiratory tract infections in patients with cystic fibrosis	100–150 mg/kg body weight per day every 8 hours, maximum 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 urinary tract infections during surgery on the prostate gland (transurethral resection)	1 g during anesthesia induction, 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, administration of 9 g per day did not cause adverse reactions.

Children with body weight < 40 kg

Infants and children older than 2 months of age with body weight < 40 kg	Infection	Usual dose
Intermittent administration
	complicated urinary tract infections	100–150 mg/kg body weight per day in 3 divided doses, maximum – 6 g per day
	chronic otitis media
	malignant external otitis
	neutropenia in children	150 mg/kg body weight per day in 3 divided doses, maximum – 6 g per day
	respiratory tract infections in patients with cystic fibrosis
	bacterial meningitis
	bacteremia*
	bone and joint infections	100–150 mg/kg body weight per day in 3 divided doses, maximum – 6 g per 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 per day, maximum – 6 g per day
	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
Infants and children aged ≤ 2 months	Infection	Usual dose
Intermittent administration
	Most infections	25–60 mg/kg body weight per day in 2 divided doses1
1In infants and children aged ≤ 2 months, the serum elimination half-life may be 2–3 times longer than in adults

*If this is related to infections listed in the section "Indications" or if there is suspicion of such infections.

Children

The safety and efficacy of administering Cezid by continuous intravenous infusion to infants and children aged ≤ 2 months have not been established.

Elderly Patients

Due to reduced ceftazidime clearance, for elderly patients with acute infections, the daily dose should not exceed 3 g, especially for patients over 80 years of age.

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 of treatment is recommended.

Renal Impairment

Ceftazidime is excreted 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 with body weight ≥ 40 kg

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. In such patients, monitoring of serum ceftazidime levels is recommended.

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

Children with body weight < 40 kg

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; it may not precisely reflect 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 use is recommended.

Recommended maintenance doses of ceftazidime in renal insufficiency: continuous infusion

Adults and children with body weight ≥ 40 kg

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 (4–5.6)	Not studied

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

Children with body weight < 40 kg

The safety and efficacy of administering the drug by continuous intravenous infusion in children with body weight < 40 kg and impaired renal function have not been established. Careful clinical monitoring of efficacy and safety of use is recommended.

If administration of the drug by continuous intravenous infusion 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 ranges from 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 can be added to dialysis fluid (usually 125 to 250 mg per 2 L of dialysis solution).

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

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

Dosage recommendations for ceftazidime in patients undergoing prolonged venovenous hemofiltration

Residual renal function (creatinine clearance, ml/min)	Maintenance dose (mg) according to ultrafiltration rate (ml/min)а
	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

and the maintenance dose should be administered every 12 hours.

Dosing recommendations for ceftazidime in patients undergoing prolonged venovenous hemodialysis

Residual renal function (creatinine clearance, mL/min)	Maintenance 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

and The maintenance dose should be administered every 12 hours.

Administration.

The drug 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 dose depends on the severity of the disease, sensitivity, site and type of infection, as well as on the patient's age and renal function.

Instructions for solution preparation

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

Dose administered		Required amount of solvent (ml)	Approximate concentration (mg/ml)
1 g	Intramuscular Intravenous bolus Intravenous infusion	3 10 50*	260 90 20

* Reconstitution for intravenous infusion must be performed in two steps (see text below).

The color of the solution varies from light yellow to amber depending on concentration, diluent, and storage conditions. Provided the recommendations are followed, the efficacy of the drug 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.

Stability of both drugs is maintained when ceftazidime at a concentration of 4 mg/mL is mixed with the following agents: 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.

Preparation of solutions for intramuscular or intravenous bolus injection:

Insert the needle of the syringe through the stopper of the vial and add the recommended volume of diluent.

Remove the syringe needle and shake the vial until a clear solution is obtained.

Turn the vial upside down. With the syringe plunger fully depressed, insert the needle into the vial. Draw the entire solution into the syringe, keeping the needle submerged in the solution at all times. Small bubbles of carbon dioxide may be disregarded.

Preparation of solutions for intravenous infusion (1 g vials) in two steps:

Insert the needle of the syringe through the stopper of the vial and add 10 mL of diluent.

Remove the syringe needle and shake the vial until a clear solution is obtained.

Do not insert an air vent needle through the stopper until the drug is completely dissolved. Insert an air vent needle through the stopper into the vial to relieve internal pressure.

Add the resulting solution to an intravenous infusion system to achieve a final volume of at least 50 mL, and administer by intravenous infusion over 15–30 minutes.

Note. To ensure sterility of the product, it is essential not to insert an air vent needle through the stopper before the drug is fully dissolved.

The prepared solution may be stored for up to 24 hours at temperatures below 25°C or for up to 7 days at temperatures up to 4°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"). Serum concentrations of ceftazidime can be reduced by hemodialysis or peritoneal dialysis.

Adverse Reactions

Adverse effects have been classified by organ systems and by frequency of occurrence: very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1,000 and < 1/100; rare ≥ 1/10,000 and < 1/1,000; 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, and agranulocytosis.

Immune system disorders: frequency not known – anaphylaxis (including bronchospasm and/or arterial hypotension).

Nervous system disorders: uncommon – dizziness, headache; frequency not known – paresthesia.

Neurological complications such as tremor, myoclonus, seizures, encephalopathy, and coma have been reported in patients with renal impairment when the dose of ceftazidime was not appropriately reduced.

Vascular disorders: common – phlebitis or thrombophlebitis at the injection site.

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 increase in 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, and reactions with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP).

General disorders and administration site conditions: common – pain and/or inflammation at the site of intramuscular injection; uncommon – fever.

Investigations: common – positive Coombs test; uncommon – as with 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. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Incompatibilities.

Cezid is less stable in sodium bicarbonate injection solution than in other intravenous solutions and therefore is not recommended as a solvent.

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

Instances of precipitate formation have been observed when vancomycin was added to a ceftazidime solution. Therefore, it is recommended to flush infusion systems and intravenous catheters between administration of these two drugs.

Packaging.

Vial; 1 or 10 vials per cardboard pack.

Prescription status. Prescription only.

Manufacturer.

ANTIBIOTICE SA

ANTIBIOTICE SA

Manufacturer's address and location of its business operations.

1 Valea Lupului Street, Iasi 707410, Romania