Florazide
FlorazideIndications
Treatment of the following infections in adults and children, including new-borns:
- hospital-acquired pneumonia;
- respiratory tract infections in patients with cystic fibrosis;
- bacterial meningitis;
- chronic otitis media;
- malignant otitis externa;
- complicated urinary tract infections;
- complicated skin and soft tissue infections;
- complicated abdominal infections;
- infections of bones and joints;
- dialysis-associated peritonitis in patients receiving continuous ambulatory peritoneal dialysis.
Treatment of bacteremia caused by any of the abovementioned infections.
Ceftazidime can be used for treating patients with neutropenia and fever induced by the bacterial infection.
Ceftazidime can be used for prevention of infectious complications in transurethral resection of the prostate.
It is important to consider ceftazidime’s antibacterial spectrum, which is mostly active against gram-negative aerobes (see sections “Precautions for use” and “Pharmacological properties”). Ceftazidime should be used concomitantly with other antibacterial agents, if there is a possibility that ceftazidime is not active against the microorganisms, which caused the infection.
The drug should be prescribed according to available official guidelines for antibiotic prescription.
Registration Certificate Number UA/17125/01/01 (1г)Registration Certificate Number UA/17125/01/02 (2г)
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INSTRUCTION
for medical use of the medicinal product
FLORAZIDE
Composition:
active substance: ceftazidime;
1 vial contains ceftazidime (in a form of ceftazidime pentahydrate) 1g or 2g;
excipient: sodium carbonate.
Pharmatheutical form. Powder for solution for injection.
Basic physical and chemical properties: white to light yellow powder.
Pharmacotherapeutic group. Antibacterial agent for systemic use. Other β-lactam antibiotics. The third generation cephalosporins.
ATC code: J01D D02.
Pharmacological properties.
Pharmacodynamics.
Ceftazidime is a bactericidal cephalosporin antibiotic, which action mechanism is associated with inhibiting bacterial cell wall synthesis.
Acquired resistance to the antibiotic differs in different regions and can change with time, and can significantly differ in some strains. It is advisable to use local data regarding the antibiotic susceptibility, especially in treating severe infections.
Susceptible microorganisms
Gram-positive aerobes: Streptococcus pyogenes, Streptococcus agalactiae.
Gram-negative aerobes: Citrobacter koseri, Escherichia coli, Haemophilus influenza, Moraxella catarrhalis, Neisseria meningitides, Proteus mirabilis, Proteus spp., Providencia spp.
Strains with possibly acquired resistance
Gram-negative aerobes: Acinetobacter baumannii, Burkholderia cepacia, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella spp., Pseudomonas aeruginosa, Serratia spp., Morganella morgani.
Gram-positive aerobes: Staphylococcus aureus, Staphylococcus pneumonia.
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.
Other: Chlamydia spp., Mycoplasma spp., Legionella spp.
Pharmacokinetics.
In patients after intramuscular injection of 1 g of the drug, its peak concentrations of 37 mg/l are rapidly achieved. 5 minutes after the intravenous bolus injection of 1 g or 2 g of the drug, its blood serum concentrations reach 87 or 170 mg/l, respectively. Therapeutically effective concentrations remain in blood serum even in 8-12 hours after intravenous and intramuscular injections. Drug’s plasma protein binding is approximately 10%. Ceftazidime concentrations exceeding MIC for the most widespread pathogens is achieved in such tissues and organs as bones, heart, bile, phlegm, intraocular, synovial, pleural and peritoneal fluids. Ceftazidime rapidly penetrates placenta and gets into breast milk. The drug poorly permeates the intact blood-brain barrier, and if there is no inflammation, its concentrations in the CNS are small. However, in the presence of inflammation in the meninges, ceftazidime concentrations in the CNS reach 4-20 mg/l and more, which equals the level of its therapeutic concentration.
Ceftazidime is not metabolized in the body. After parenteral administration, there is high and steady ceftazidime concentration in the blood plasma. The elimination half-life is approximately 2 hours. The drug is excreted unchanged in urine through glomerular filtration; approximately 80-90% of the dose is excreted in urine during 24 hours. In patients with impaired renal function, ceftazidime elimination is slower, thus, the dose needs to be adjusted. Less than 1% of the drug is excreted in bile, which significantly limits the amount of the drug in the intestine.
Clinical particulars.
Indications.
Treatment of the following infections in adults and children, including new-borns:
- hospital-acquired pneumonia;
- respiratory tract infections in patients with cystic fibrosis;
- bacterial meningitis;
- chronic otitis media;
- malignant otitis externa;
- complicated urinary tract infections;
- complicated skin and soft tissue infections;
- complicated abdominal infections;
- infections of bones and joints;
- dialysis-associated peritonitis in patients receiving continuous ambulatory peritoneal dialysis.
Treatment of bacteremia caused by any of the abovementioned infections.
Ceftazidime can be used for treating patients with neutropenia and fever induced by the bacterial infection.
Ceftazidime can be used for prevention of infectious complications in transurethral resection of the prostate.
It is important to consider ceftazidime’s antibacterial spectrum, which is mostly active against gram-negative aerobes (see sections “Precautions for use” and “Pharmacological properties”). Ceftazidime should be used concomitantly with other antibacterial agents if there is a possibility that ceftazidime is not active against the microorganisms, which caused the infection.
The drug should be prescribed according to available official guidelines for antibiotic prescription.
Contraindications.
Hypersensitivity to ceftazidime or other components of the drug.
Hypersensitivity to cephalosporins.
Medical history of 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 preparation with nephrotoxic medicinal agents might have a negative effect on renal function (see section «Precautions for use”).
Chloramphenicol in vitro is antagonist of ceftazidime and other cephalosporins. The clinical significance of this data is unknown; however, if concomitant use of ceftazidime and chloramphenicol is considered, the possibility of antagonism should be taken into account.
Like other antibiotics, ceftazidime might affect intestinal flora, which leads to decrease in reabsorption of estrogens and reduced efficacy of combined oral contraceptives.
Ceftazidime has no effect on glucose determination by enzyme methods, but there is a little effect on the test results obtained from the Benedict’s test, Fehling’s test, and Clinitest. Ceftazidime does not affect the alkaline picrate method of creatinine estimation.
Precautions for use.
Like with other beta-lactam antibiotics, severe and sometimes fatal hypersensitivity reactions were reported. In case severe hypersensitivity reaction occurs, treatment with ceftazidime should be immediately discontinued and immediate measures should be taken.
Before the beginning of the treatment, patient’s medical history should be checked for severe hypersensitivity reactions to ceftazidime, cephalosporins or other beta-lactam antibiotics. Caution should be exercised if the drug is prescribed to patients with moderate hypersensitivity reactions to other beta-lactam antibiotics.
Ceftazidime has a limited spectrum of antibacterial activity. It cannot be used as monotherapy for treatment of certain infections, unless the pathogen and its susceptibility are unknown, or if there is a possibility that the pathogen is susceptible to ceftazidime. It is especially important when choosing the treatment for patients with bacteremia, bacterial meningitis, skin and soft tissue infections, and bone and joint infections. In addition, ceftazidime is susceptible to hydrolysis by several of the extended spectrum beta lactamases (ESBLs). Therefore, information on the prevalence of ESBL producing organisms should be taken into account when choosing ceftazidime for treatment.
Concomitant treatment of high doses of cephalosporins and nephrotoxic agents, like aminoglycosides or potent diuretics (for example, furosemide), can have a negative effect on renal function. Experience of clinical use of ceftazidime has shown that such events are unlikely, if ceftazidime is administered at recommended doses. There is no data regarding ceftazidime negative effect on renal function when administered at therapeutic doses.
Ceftazidime is mostly excreted by kidneys, so the dose needs to be reduced depending on the severity of renal function impairment. Some cases of neurologic complications were reported when the dose was not reduced accordingly (see sections “Routes of administration and dosage” and “Adverse reactions”).
Similar to other broad-spectrum antibiotics, long-term treatment with ceftazidime might lead to excessive growth of unsusceptible bacteria (e.g., Candida Enterococci); in this case, treatment should be discontinued and necessary measures should be taken. It is very important to constantly monitor the patient’s state.
Mild to life-threatening pseudomembranous colitis has been reported during the antibiotic administration. This should be kept in mind when diagnosing patients with diarrhoea developed during or after the drug administration. In case of continuous and severe diarrhoea or if abdominal muscle spasms occur, the treatment should be immediately discontinued. The patient’s state should be checked and, if necessary, the treatment of Clostridium difficile should be initiated. Preparations that slow intestinal motility should not be prescribed.
Like with other cephalosporins and broad-spectrum penicillins, some earlier susceptible strains of Enterobacter spp. and Serratia spp. might acquire resistance during the treatment with ceftazidime.
Ceftazidime contains sodium, which should be taken into account while treating patients on a sodium-controlled diet.
Use during pregnancy and lactation.
There are limited data on treatment of pregnant women with ceftazidime. The drug should be prescribed to pregnant patients only if the benefits of its use outweigh the possible risk.
Ceftazidime is excreted into breast milk in small amounts, but the therapeutic doses of the drug have no effect on new-borns who are breastfed. Ceftazidime can be used during lactation.
Effects on reaction rate while driving vehicles or operating other machinery
No relevant studies have been conducted. However, occurrence of such adverse reactions as dizziness might influence the ability to drive vehicles or operate other machinery (see section “Adverse reactions”).
Routes of administration and dosage.
Adults and children with body weight ≥ 40 kg
Table 1
Intermittent administration |
|
Infection |
Administered dose |
Respiratory tract infections in patients with cystic fibrosis |
100–150 mg/kg body weight/day every 8 hours, maximum up to 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 |
Prevention of infectious complications in transurethral resection of the prostate |
1 g during induction of anaesthesia, 1 g when removing catheter |
Chronic otitis media |
1–2 g every 8 hours |
Malignant otitis externa |
|
Continuous infusion |
|
Infection |
Administered dose |
Febrile neutropenia |
The loading dose of 2 g with the subsequent constant infusion of 4 to 6 g is administrated 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 has not led to development of adverse reactions.
Children with body weight < 40 kg
Table 2
Newborns and children aged >2 months and with body weight < 40 kg |
Infection |
Normal dose |
Intermittent administration |
||
|
Complicated urinary tract infections |
100–50 mg/kg body weight/day split into 3 administrations, maximum of 6 g per day |
Chronic otitis media |
||
Malignant otitis externa |
||
Neutropenia in children |
150 mg/kg body weight/day split into 3 administrations, maximum of 6 g per day |
|
Respiratory tract infections in patients with cystic fibrosis |
||
Bacterial meningitis |
||
Bacteremia* |
||
Bone and joint infections |
100–50 mg/kg body weight/day split into 3 administrations, maximum of 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 |
Loading dose of 60–100 mg/kg body weight is administered, followed by a constant infusion of 100–200 mg/kg body weight per day, maximum of 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 |
||
New-borns and children aged ≤ 2 months |
Infection |
Normal dose |
Intermittent administration |
||
|
Most infections |
25–60 mg/kg body weight/day split into 2 administrations1 |
1In new-borns and children aged ≤ 2 months, the serum half-life can be 2-3 times longer than in adults
*If associated or suspected to be associated with infections mentioned in the section “Indications”.
Children
Safety and efficacy of ceftazidime continuous intravenous infusion in newborns and children aged ≤ 2 months have not been determined.
Elderly patients
Considering reduced ceftazidime clearance in elderly patients with acute infections, the daily dose should not exceed 3 g, especially for patients aged over 80 years.
Liver impairment
There is no need to adjust the dose for patients with mild and moderate liver impairment. No clinical studies involving patients with severe liver impairment have been conducted. Thorough clinical monitoring for the efficacy and safety of the drug use is recommended.
Renal impairment
Ceftazidime is excreted by the kidneys unchanged. Therefore, patients with renal impairment need dose reduction.
The initial loading dose is 1 g. Determination of the maintenance dose should be based on creatinine clearance.
Recommended maintenance doses of ceftazidime in patients with renal impairment – intermittent administration
Adults and children with body weight ≥ 40 kg
Table 3
Creatinine clearance, ml/min |
Approximate creatinine level in blood plasma, 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 |
In patients with severe infections, the single dose can be increased by 50% or the frequency of administrations can be increased respectively. It is recommended to control the ceftazidime blood serum level in such patients.
In children, creatinine clearance should be corrected to a body surface area or to body weight.
Children with body weight < 40 kg
Table 4
Creatinine clearance, ml/min** |
Approximate creatinine level* in blood serum, 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 |
* Creatinine level in blood serum is calculated according to the guidelines and might not exactly correspond to the rate of kidney function decline in all patients with renal impairment.
** Creatinine clearance either calculated based on body surface area or determined.
Thorough clinical monitoring for the drug efficacy and safety is recommended.
Recommended maintenance doses of ceftazidime in patients with renal impairment – continuous infusion
Adults and children with body weight ≥ 40 kg
Table 5
Creatinine clearance, ml/min |
Approximate creatinine level in blood plasma, µmol/l (mg/dl) |
Dosing interval, hours |
50–31 |
150–200 (1,7–2,3) |
Loading dose of 2g, followed by continuous infusion of 1 g to 3 g every 24 hours |
30–16 |
200–350 (2,3–4) |
Loading dose of 2 g, followed by continuous infusion of 1 g every 24 hours |
≤ 15 |
> 350 > 4 |
No studies have been conducted |
The choice of dose should be made with caution. A thorough clinical monitoring for efficacy and safety of the drug use should be maintained.
Children with body weight < 40 kg
In paediatric patients with renal impairment and body weight < 40 kg, safety and efficacy of continuous intravenous infusions have not been assessed. A thorough clinical monitoring for efficacy and safety of the drug use should be maintained.
If it is necessary to administer the drug through continuous intravenous infusions in children with renal impairment, creatinine clearance should be corrected to body surface area or to body weight.
Haemodialysis
Ceftazidime elimination half-life from blood serum during haemodialysis is 3 to 5 hours.
After each haemodialysis session, the maintenance dose of ceftazidime recommended in the table 6 should be administered.
Peritoneal dialysis
Ceftazidime can be used in patients receiving peritoneal dialysis at regular regimen and continuous ambulatory peritoneal dialysis.
Apart from intravenous use, ceftazidime can be included into dialysis fluid (usually from 125 to 250 g for 2 l of dialysis solution).
In patients with renal impairment receiving continuous vascular haemodialysis or high-volume hemofiltration in ICUs, the recommended dose is 1 g per day as either a single dose or few administrations. Low-volume hemofiltration requires the same doses as in patients with renal impairment.
Recommendations for patients receiving veno-venous hemofiltration and veno-venous haemodialysis are presented in Tables 6 and 7.
Dosage recommendations for patients receiving continuous veno-venous hemofiltration
Table 6
Residual renal function (creatinine clearance, ml/min) |
Maintenance dose (mg) depending on the 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 |
а Maintenance dose should be administered every 12 hours.
Ceftazidime dosage recommendations for patients receiving continuous veno-venous haemodialysis
Table 7
Residual renal function (creatinine clearance, ml/min) |
Maintenance dose (mg) for dialysate flow rates (ml/min)а |
|||||
1 l/hr |
2 l/hr |
|||||
Ultrafiltration rate (l/hr) |
Ultrafiltration rate (l/hr) |
|||||
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 |
а Maintenance dose should be administered every 12 hours
Administration.
Ceftazidime should be administered through intravenous infusions or injections, or through deep intramuscular injection. The recommended areas for intramuscular injections are the upper outer quadrant of the gluteus maximus or the vastus lateralis muscle.
Ceftazidime solutions can be administered directly into veins or into the system for intravenous infusions, if the patient receives liquids parenterally.
The dose depends on the severity of the illness, on the susceptibility, localization and type of the infection, and also on the patient’s age and renal function.
Acquired antibiotic resistance varies in different regions and can change over time, and can be significantly different for some strains. It is advisable to use local data on antibiotic resistance, especially when treating severe infections.
Instruction for preparing solutions
Ceftazidime is compatible with most commonly used solutions for infusion. However, sodium bicarbonate solution for injection should not be used as a solvent (see section “Incompatibility”). In the vial, the pressure is lowered. As the drug dissolves, carbon dioxide is produced, and the pressure in the vial increases. The small carbon dioxide bubbles in the dissolved solution may be disregarded.
Table 8
Route of administration and dose |
Necessary amount of solvent (ml) |
Approximate concentration (mg/ml) |
|
1 g |
Intramuscular Intravenous bolus Intravenous infusion |
3 10 50* |
260 90 20 |
2 g |
Intravenous bolus Intravenous infusion |
10 50* |
170 40 |
*Dilution for making intravenous infusion should be carried out in 2 stages (see text).
The solution’s colour varies from light yellow to amber, depending on the concentration, solvent and storage conditions. If the guidelines are followed, the effect of the drug does not depend on its colour variations.
Ceftazidime in concentrations from 1 mg/ml to 40 mg/ml is compatible with such solutions: 0.9% sodium chloride solution; M/6 sodium lactate solution; Hartmann’s solution; 5% glucose solution; 0.45% sodium chloride solution and 5% glucose solution; 0.18% sodium chloride solution and 4% glucose solution; 10% glucose solution; 10% glucose solution and 0.9% sodium chloride solution; 10% glucose solution and 5% glucose solution; 6% dextran 70 solution and 5% glucose solution.
Ceftazidime in concentrations from 0.05 mg/ml to 0.25 mg/ml is compatible with peritoneal dialysis fluid (lactate).
Ceftazidime for intramuscular administrations can be diluted in 0.5% or 1% lidocaine hydrochloride solution.
Both preparations remain effective when 4 mg/ml dose of ceftazidime is mixed with the following agents: hydrocortisone (hydrocortisone sodium phosphate) 1 mg/ml in 0.9% sodium chloride solution for injection or 0.5% glucose solution; cefuroxime (cefuroxime sodium) 3 mg/ml in 0.9% sodium chloride solution for injection; cloxacilline (cloxacilline sodium) 4 mg/ml in 0.9% sodium chloride solution for injection; heparin 10 IU/ml or 50 IU/ml in 0.9% sodium chloride solution for injection; kalium chloride 10 mEq/l or 40 mEq/l in 0.9% sodium chloride solution for injection.
Preparing solutions for intramuscular or intravenous bolus injections.
- Insert the needle into the vial through the vial top and inject the necessary amount of solvent.
- Remove the needle from the vial and shake the vial until the solution becomes transparent.
- Turn the vial upside down. Push the plunger in and insert the needle into the vial. Fill the syringe with the medicine, keeping the needle tip in the solution. Small carbon dioxide bubbles may be disregarded.
Preparing solutions for intravenous infusion (vials 1 g and 2 g) in 2 stages:
- Insert the needle into the vial through the vial top and inject 10 ml of the solvent.
- Remove the needle from the vial and shake the vial until the solution becomes transparent.
- Do not insert the needle for air until the preparation fully dissolves. Inject the needle for air through the vial top to reduce the internal pressure.
- Without removing the needle for air, make the total volume 50 ml, use for an intravenous infusion during 15-30 minutes. Remove the needle for air, shake the vial and set up the IV as usual.
In order to maintain the preparation’s sterility, it is very important not to inject the needle for air through the vial top before the preparation dissolves.
Prepared solution can be kept for no more than 8 hours at temperature not exceeding 25 °С, and no more than 24 hours at temperature from 2 to 8 °С.
Children.
Use in children from first days of life. The efficacy and safety of ceftazidime use through continuous intravenous infusions in new-borns and children ≤ 2 months old have not been determined.
Overdose.
Overdose might lead to such neurological complications as encephalopathy, seizures, and coma. The symptoms of overdose might occur in patients with renal failure if the dose is not adjusted accordingly (see sections “Method of administration and dosage” and “Precautions for use”). Ceftazidime concentration in blood plasma can be reduced through haemodialysis or peritoneal dialysis.
Adverse reactions.
Adverse reactions have been classified according to the frequency of their occurrence – from very common to uncommon, and also according to the organs and systems: very common ³ 1/10; common ³ 1/100 and < 1/10; uncommon ³ 1/1000 and < 1/100; rare ³ 1/10000 and < 1/1000; very rare < 1/10000; not known frequency.
Infections and invasions
Uncommon – candida (including vaginitis and oral thrush).
Circulatory and lymphatic systems.
Common – eosinophilia and thrombosis.
Uncommon – leukopenia, neutropenia and thrombocytosis.
Not known frequency – lymphocytosis, haemolytic anaemia, and agranulocytosis.
Immune system
Not known frequency – anaphylaxis (including bronchospasm and/or arterial hypotension).
Nervous system
Uncommon – dizziness, headache.
Not known frequency – paraesthesiae.
Such neurological complications as tremor, myoclonia, seizures, encephalopathy and coma in patients with renal failure, for whom ceftazidime dose has not been adjusted, were reported.
Vascular disorders
Common – phlebitis or thrombophlebitis at injection site.
Gastrointestinal disorders
Common – antibiotic-associated diarrhoea
Uncommon – nausea, vomiting, stomach crumps and colitis.
Like with other cephalosporins, colitis might be associated with Clostridium difficile and occur in a form of pseudomembranous colitis (see section «Precautions for use”).
Not known frequency – dysgeusia.
Urinary system
Uncommon – transient increase of urea blood concentration.
Very rare – interstitial nephritis, acute renal failure.
Hepatobiliary reactions
Common – transient increase of one or several liver enzymes (ALT, AAT, LDH, GGTP, alkaline phosphatase).
Not known frequency – jaundice.
Skin and subcutaneous tissues
Common – maculopapular rash or urticaria.
Uncommon – itching.
Not known frequency – angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS-syndrome.
General reactions and disorders at injection site
Common – pain and/or inflammation at intramuscular injection site.
Uncommon – fever.
Laboratory test results
Common – positive Coombs test.
Uncommon – like with other cephalosporins, sometimes a transient increase of blood urea, blood urea nitrogen, and/or creatinine levels in blood serum was reported.
Positive Coombs test is observed in approximately 5% of patients, which can affect blood typing.
Storage life.
2 years.
Storage conditions.
Store in the original package at a temperature not exceeding 25 °С. Keep out of reach of children. Prepared solution should be kept no more than 8 hours at a temperature not exceeding 25 °С and no more than 24 hours at a temperature from 2 to 8 °С.
Incompatibility.
Ceftazidime is less stable in sodium bicarbonate solution for injection than in other solutions for intravenous administration, thus, it is not recommended as a solvent.
Ceftazidime and aminoglycosides should not be mixed in the same infusion system or syringe.
Sludge formation has been reported when vancomycin was added to the ceftazidime solution. Therefore, it is recommended to flush the infusion systems and venous catheters between the use of the two preparations.
Packaging. Powder in a glass vial with a rubber stopper and aluminium flip off cap, one vial in a box.
Terms of dispensing.
On prescription.
Manufacturer.
Swiss Parenterals Ltd.
Manufacturer’s registered address.
Unit ІІ, 402, 412-414 Kerala GIDC, Near Bavla, Ahmedabad, Ahmedabad, Gujarat, 382 220, India.
Applicant.
Ananta Medicare Ltd.
Applicant’s and/or declarant’s representative’s registered address.
Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.
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