Ceftazidime ananta

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

Composition:

Active substance: ceftazidime;

1 vial contains ceftazidime pentahydrate (as a sterile mixture with anhydrous sodium carbonate) equivalent to 1 g of ceftazidime;

Excipient: anhydrous sodium carbonate.

Pharmaceutical form. Powder for solution for injection.

Main physicochemical properties: crystalline powder, white to cream-colored.

Pharmacotherapeutic group. Antibacterial agent for systemic use. Other 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 observed among individual strains. Local data on antibiotic susceptibility should be used whenever possible, especially when treating severe infections.

Susceptible microorganisms

Gram-positive aerobes: Streptococcus pyogenes, Streptococcus agalactiae.

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

Strains capable of developing resistance

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

Gram-positive aerobes: Staphylococcus aureus, Staphylococcus pneumoniae.

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.

After intramuscular injection of 1 g of the drug, mean peak serum concentrations of 37 mg/L are rapidly achieved. Five minutes after intravenous bolus administration of 1 g or 2 g, mean serum concentrations of 87 mg/L or 170 mg/L are achieved, respectively. Therapeutically effective concentrations persist in serum for up to 8–12 hours after both intravenous and intramuscular administration. Plasma protein binding is approximately 10%. Therapeutic concentrations of ceftazidime exceeding the minimum inhibitory concentration for most common pathogenic microorganisms are achieved in various tissues and body fluids such as bone, heart, bile, sputum, intraocular fluid, synovial fluid, pleural fluid, and peritoneal fluid. Ceftazidime rapidly crosses the placental barrier and is excreted into breast milk. The drug poorly penetrates the intact blood-brain barrier; in the absence of inflammation, drug concentrations in the central nervous system (CNS) are low. However, during meningitis, ceftazidime concentrations in the CNS range from 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 administered dose is excreted 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 of drug 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 resulting from bacterial infection.

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

When prescribing ceftazidime, its antibacterial spectrum of activity, primarily directed against Gram-negative aerobes, should be taken into account (see sections "Special precautions for use" and "Pharmacological properties").

Ceftazidime should be used in combination with other antibacterial agents if a range of microorganisms causing the infection are expected to fall outside the spectrum of ceftazidime activity.

The drug should be prescribed in accordance with current official guidelines on 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.

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

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

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

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

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

Special precautions.

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

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 non-severe hypersensitivity reactions to other beta-lactam antibiotics.

During ceftazidime treatment, severe skin adverse reactions have been reported with an unknown frequency, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), which may be life-threatening or lead to fatal outcomes.

Patients should be informed about the signs and symptoms of these reactions, and careful monitoring for skin reactions is required.

If signs or symptoms suggestive of these reactions appear, ceftazidime should be discontinued immediately, and alternative therapy should be considered.

If a serious reaction such as SJS, TEN, DRESS, or AGEP develops during ceftazidime treatment, ceftazidimed therapy must never be restarted.

Ceftazidime has a limited antibacterial spectrum. It is not an appropriate agent for monotherapy of certain types of infections, except when the causative pathogen is unknown or there is a high probability that the likely pathogen will be susceptible to ceftazidime. This is particularly important when considering treatment of patients with bacteremia, bacterial meningitis, skin and soft tissue infections, or 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 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, the dose should be reduced 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 Ananta 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. Careful ongoing monitoring of the patient is essential.

Cases of pseudomembranous colitis of varying 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. In cases of persistent or severe diarrhea, or if abdominal cramps occur, treatment should be discontinued immediately, further diagnostic evaluation should be performed, and specific therapy for Clostridium difficile should be initiated if necessary. Medicinal products that inhibit intestinal peristalsis should not be administered.

As with other broad-spectrum cephalosporins and penicillins, some initially 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 sodium (a 1 g ceftazidime vial contains 52 mg of sodium), which should be taken into account when treating patients on a sodium-restricted diet.

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 postnatal development. The drug should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ceftazidime passes into breast milk in small amounts, but with therapeutic doses, no effect on the breastfed infant is expected. Ceftazidime may be used during breastfeeding.

Ability to affect the speed of reactions when driving or operating machinery.

No specific studies have been conducted. However, the occurrence of side effects such as dizziness may affect the ability to drive or operate machinery (see section "Side effects").

Method of administration and dosage.

Adults and children ≥ 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 dose – 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 prostate surgery (transurethral resection)	1 g at induction of anesthesia, 1 g 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, no adverse reactions occurred after administration of 9 g per day.

Children <40 kg

Infants and children aged > 2 months and 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 dose – 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 dose – 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 dose – 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 dose – 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 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 half-life may be 2–3 times longer than in adults

*If this is related or suspected to be related to infections listed in the section "Indications".

Children.

The safety and efficacy of Ceftazidime Ananta administered by continuous intravenous infusion in infants and children aged ≤ 2 months 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, particularly 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 of use 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 dose should be 1 g. Maintenance dosing should be based on glomerular filtration rate.

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 < 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, which may not precisely correspond to the actual degree of renal function impairment in patients with kidney failure.

** Creatinine clearance calculated based on body surface area or measured directly.

Careful clinical monitoring of efficacy and safety is recommended.

Recommended maintenance doses of ceftazidime in renal impairment: 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

The dose should be administered with caution. Careful clinical monitoring of efficacy and safety of use is recommended.

Children < 40 kg

The safety and efficacy of administering Ceftazidime Ananta by continuous intravenous infusion in children with impaired renal function and body weight < 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 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.

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

For patients with renal insufficiency undergoing prolonged arteriovenous hemodialysis or high-flux hemofiltration in intensive care units, the recommended dose is 1 g daily, administered either 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, dosing recommendations are provided in the tables.

Dosing 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)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.

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

The maintenance dose should be administered every 12 hours.

Administration.

Ceftazidime is administered by intravenous 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, location, and type of infection, as well as the patient's age and renal function.

Acquired resistance to the antibiotic varies among different regions and may change over time, with significant differences observed in individual strains. Local antibiotic susceptibility data should preferably be used, especially when treating severe infections.

Preparation of the solution.

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

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

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

* Reconstitution should be performed in two steps (see below).

The solution color varies from light yellow to amber depending on concentration, diluent, and storage conditions. When 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 peritoneal dialysis fluid (lactate).

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

When using lidocaine solution as diluent for intramuscular administration, lidocaine safety information must be taken into account.

The efficacy 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.

The contents of one vial of Ceftazidime Ananta 1 g, reconstituted with 1.5 mL of water for injections, may be added to a metronidazole solution (500 mg in 100 mL), and both drugs retain their activity.

Preparation of solutions for intramuscular or intravenous bolus injection

1. Insert the syringe needle through the vial stopper and add 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 syringe plunger fully depressed, insert the needle into the vial. Withdraw the entire solution into the syringe, ensuring the needle remains submerged in the solution at all times. Small bubbles of carbon dioxide may be disregarded.

Preparation of solutions for intravenous infusion (1 g vials)

1. Insert the syringe needle through the vial stopper and add 10 mL of diluent.
2. Remove the syringe needle and shake the vial until a clear solution is obtained.
3. 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.
4. Without removing the air vent needle, adjust the total volume to 50 mL. Remove the air vent needle, shake the vial, and set up the infusion system as usual.

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

The prepared solution may be stored for up to 8 hours at temperatures not exceeding 25°C and for up to 24 hours at 2–8°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 are classified by organ systems and frequency of occurrence: very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1000 and < 1/100; rare ≥ 1/10,000 and < 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, 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, 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 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 manifest as pseudomembranous colitis (see section "Special warnings and precautions for use").

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, 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.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is of great importance. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, and patients or their legal representatives should report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life

2 years.

Storage conditions

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

Keep out of the reach of children.

Incompatibilities

Ceftazidime Ananta is less stable in solutions of sodium bicarbonate for injection than in other intravenous diluents and therefore is not recommended as a solvent.

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

Precipitation has been observed when vancomycin was added to ceftazidime solution. Therefore, infusion systems and intravenous catheters should be flushed between administration of these two drugs.

Packaging

1 vial of powder in a cardboard box.

Prescription status

Prescription-only medicine.

Manufacturer

Ananta Medikare Limited.

Manufacturer's address

Chak 17 ML, Agro Food Park Road, RIICO Industrial Area, Udiog Vihar, Sri Ganganagar-335002 (Rajasthan), India.

Marketing authorization holder

Ananta Medikare Ltd.

Address of the marketing authorization holder and/or its representative

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.