Medacet - 1000

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEDACET-1000 (MEDACET-1000)

Composition:

Active substance: ceftazidime;

One vial contains ceftazidime pentahydrate equivalent to ceftazidime 1000 mg;

Excipient: sodium carbonate.

Pharmaceutical form. Powder for solution for injection.

Main physicochemical characteristics: white or almost white crystalline powder.

Pharmacotherapeutic group. Systemic antibacterial agents. Third-generation cephalosporins. ATC code J01D D02.

Pharmacological Properties

Pharmacodynamics

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

Acquired resistance to the antibiotic varies in different regions and may change over time, with significant differences observed among individual strains. Local data on antibiotic susceptibility and the prevalence of microorganisms producing extended-spectrum beta-lactamases should be consulted, 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 potential 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 streptococcus.

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 500 mg and 1 g, mean peak serum concentrations of 18 mg/L and 37 mg/L are rapidly achieved, respectively. Within 5 minutes after intravenous bolus administration of 500 mg, 1 g, or 2 g, mean serum concentrations of 46 mg/L, 87 mg/L, or 170 mg/L are achieved, respectively. Therapeutically effective concentrations persist in serum for up to 8–12 hours after intravenous or intramuscular administration. Plasma protein binding is approximately 10%. Therapeutic concentrations exceeding the MIC (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 crosses the placenta and is excreted 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, 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 are achieved. The elimination half-life is approximately 2 hours. The drug is excreted unchanged and in active form via the kidneys by 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 from any of the above-mentioned infections.

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

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

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

Ceftazidime should be used in combination with other antibacterial agents if a range of 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 medicinal product.

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 types of interactions

Concomitant administration of high doses of ceftazidime with nephrotoxic medicinal products may adversely affect renal function (see section “Special precautions”).

Chloramphenicol is an in vitro antagonist of ceftazidime and other cephalosporins. The clinical significance of this phenomenon is unknown; however, if concomitant use of ceftazidime and chloramphenicol is considered, potential antagonism should be taken into account.

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 glucose in urine testing by enzymatic methods; however, a minor interference may be observed when using copper reduction methods (Benedict’s, Fehling’s, Clinitest).

Ceftazidime does not interfere with creatinine measurement by the alkaline picrate method.

Special precautions for use

Severe skin adverse reactions, 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 with ceftazidime treatment, which may be life-threatening or lead to fatal outcomes (frequency unknown). Patients should be informed about the signs and symptoms, and careful monitoring for skin reactions is required. If symptoms indicating such reactions occur, ceftazidime should be discontinued immediately and alternative therapy considered. If a serious reaction such as SJS, TEN, DRESS, or AGEP develops during ceftazidime treatment, re-administration of ceftazidimed must be avoided under any circumstances.

Severe and sometimes fatal hypersensitivity reactions have been reported with the use of beta-lactam antibiotics, including ceftazidime. In case of severe hypersensitivity reactions, ceftazidime therapy should be discontinued immediately and appropriate emergency measures initiated.

Prior to initiating therapy, patients should be questioned about previous history of severe 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.

Ceftazidime has a limited antibacterial spectrum. 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 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 treatment with 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 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 may lead to overgrowth of non-susceptible microorganisms (e.g., Candida, Enterococci); in such cases, discontinuation of treatment or other necessary measures may be required. Continuous monitoring of the patient's condition is essential.

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 and severe diarrhea or abdominal cramps occur, treatment should be discontinued immediately, further investigations performed, and specific therapy for Clostridium difficile initiated if necessary. 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 medicinal product contains 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, embryonic or postnatal development. The drug should be administered to pregnant women only if the potential benefit outweighs the possible risk.

Ceftazidime is excreted in breast milk in small amounts, but effects on the breastfed infant are not expected with therapeutic doses. Ceftazidime may be used during breastfeeding.

Ability to influence the ability to drive and use machines

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

Dosage and Administration

Table 1

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/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 infectious complications during prostate surgery (transurethral resection)	1 g at the time of 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	loading dose of 2 g followed by continuous infusion of 4 g 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.

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

Table 2

Children with body weight < 40 kg

Infants and children aged > 2 months and weighing < 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
	bacteraemia*
	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, up to a maximum of 6 g per 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 aged ≤ 2 months	Infection	Usual dose
Intermittent administration
	Most infections	25–60 mg/kg body weight per day in 2 divided doses1
1 In infants and children aged ≤ 2 months, the serum half-life may be 2–3 times longer than in adults.

* If this is associated with or there is suspicion of association with the infections listed in the section "Indications".

Children

The safety and efficacy of ceftazidime administered 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 for 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 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

Table 3

Adults and children with body weight ≥ 40 kg body weight

Creatinine clearance, mL/min	Approximate serum creatinine level, µmol/L (mg/dL)	Recommended single dose of ceftazidime, g	Dosing interval (hr)
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.

Table 4

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 interval (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

* Serum creatinine level calculated according to recommendations; 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 administration is recommended.

Recommended maintenance doses of ceftazidime in renal insufficiency: continuous infusion

Table 5

Adults and children with body weight ≥ 40 kg body weight

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

Dosing should be performed cautiously. Careful clinical monitoring of efficacy and safety of use is recommended.

Children with body weight < 40 kg

The safety and efficacy of ceftazidime administered 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 children with impaired renal function require administration of the medicinal product by continuous intravenous infusion, creatinine clearance should be adjusted according to the child's body surface area or body weight.

Hemodialysis

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

A maintenance dose of ceftazidime, as recommended in tables 6–7 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 dialysis fluid (typically 125 mg to 250 mg per 2 L of dialysis solution).

For patients with renal insufficiency undergoing prolonged arteriovenous hemofiltration 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 as for impaired renal function.

Dosing recommendations for patients undergoing venovenous hemofiltration and venovenous hemodialysis are provided in tables 6–7.

Table 6

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

and the maintenance dose should be administered every 12 hours.

Table 7

Dosing recommendations for ceftazidime in patients undergoing prolonged venovenous hemodialysis

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

and the maintenance dose should be administered every 12 hours.

Administration

The medicinal product 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 aspect 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.

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 section "Incompatibilities").

All vials are under reduced pressure. Carbon dioxide is released during reconstitution, leading to increased pressure in the vial. Small bubbles of carbon dioxide in the reconstituted solution can be disregarded.

Dose administered		Required amount of diluent (ml)	Approximate concentration (mg/ml)
1000 mg	Intramuscular Intravenous bolus Intravenous infusion	3 10 50*	260 90 20

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

The color of the solution may vary from light yellow to amber depending on concentration, diluent, and storage conditions. Provided that the recommendations are followed, the drug's activity 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).

Ceftazidime for intramuscular administration may be dissolved in 0.5% or 1% lidocaine hydrochloride solution.

The stability of both agents is maintained when mixing ceftazidime at a concentration of 4 mg/mL 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.

The contents of the Medacete-1000 vial, reconstituted with 1.5 mL of water for injections, may be added to a metronidazole solution (500 mg in 100 mL), with both drugs retaining their activity.

Preparation of solutions for intramuscular or intravenous bolus injection

1. Insert the needle of the syringe 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 in the solution at all times. Small bubbles of carbon dioxide may be disregarded.

Preparation of solutions for intravenous infusion

1. Insert the needle of the syringe 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. After complete dissolution, insert an air vent needle through the stopper into the vial to relieve internal pressure.
4. Add the resulting solution to an intravenous infusion system, making up to a total volume of at least 50 mL, and administer by intravenous infusion over 15–30 minutes.

Note. To ensure sterility of the preparation, 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

Can be administered to 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 precautions"). Serum concentrations of ceftazidime can be reduced by hemodialysis or peritoneal dialysis.

Adverse Reactions

Adverse reactions are classified by organ systems and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from available data).

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, haemolytic anaemia, and agranulocytosis.

Immune system disorders

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

Nervous system disorders

Uncommon — dizziness, headache.

Frequency not known — paraesthesia.

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

Vascular disorders

Common — phlebitis or thrombophlebitis at the injection site.

Gastrointestinal disorders

Common — diarrhoea.

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 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 [alanine aminotransferase], AST [aspartate aminotransferase], LDH [lactate dehydrogenase], GGT [gamma-glutamyl transferase], alkaline phosphatase).

Frequency not known — jaundice.

Skin and subcutaneous tissue disorders

Common — maculopapular rash or urticaria.

Uncommon — pruritus.

Frequency not known — angioneurotic oedema, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised 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 some other cephalosporins, transient increases in blood urea, blood urea nitrogen, and/or serum creatinine have been observed.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicine authorization is important. It allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals, pharmacists, patients, or their legal representatives should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions

Store at temperatures not exceeding 30 °C in the original packaging.

Keep out of the reach of children.

Incompatibilities

Ceftazidime is less stable in solutions of sodium bicarbonate for injection than in other intravenous solutions 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 a 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 package.

Prescription status. Prescription only.

Manufacturer. Sams Labortories Pvt. Ltd.

Manufacturer's address and place of business. VI/51B, P.O. Box No. 2, Kozhuvanal, Pala, Kottayam – 686 573, Kerala, India.