Ingredients:

1000 mg ceftazidime powder for injection solution in 1 vial,

1 ampoule contains 10 ml of water for injection. 

Description: Milk-colored crystalline powder for solution for injection.

Solvent: clear, colorless solution.

​

pharmacological properties

Pharmacodynamics: Ceftazidime breaks down penicillin-related proteins (PBP 3), which have an enzymatic effect on the synthesis of peptidoglycan. It is known that some PBPs act as transpeptidases. Peptidoglycan is synthesized in the form of a linear chain. Ceftazidime causes cell wall damage and bacterial cell lysis by disrupting the cross-linking between peptidoglycan chains. As a result, it has a bactericidal effect by disrupting the synthesis of the cell walls of microorganisms. It has a broad antimicrobial spectrum (including strains resistant to gentamicin and other aminoglycoside antibiotics). It is resistant to many β-lactamases, plasmids or chromosomes secreted by gram (-) and gram (+) bacteria, strains resistant to ampicillin and other cephalosporins. Ceftazidime is active against many gram-negative, gram-positive and anaerobic bacteria.
Pharmacokinetics: Cmax of 139 mcg/ml in blood plasma after intravenous administration of 1 g of ceftazidime and 43 mcg/ml after intravenous administration. The binding of ceftazidime to plasma proteins is 10%. The drug is well distributed in the body. It creates a therapeutic concentration in urine, bile, synovial, pleural and abdominal fluid, the contents of the eye chambers, lymphatic fluid, bone tissue, myometrium, myocardium, skin tissue, skeletal muscle, sputum and pleura. The drug hardly passes through the hematoencephalic barrier in the absence of an inflammatory process in the body. It creates a therapeutic concentration in the cerebrospinal fluid in inflammatory diseases of the meninges. It easily crosses the placental barrier and is excreted in breast milk. It is not metabolized in the body. After parenteral administration of the drug, its plasma concentration decreases due to the elimination half-life (1.8-2.2 hours). Ceftazidime is eliminated unchanged in the urine by glomerular filtration; approximately 80-90% of the intramuscular and intravenous dose is excreted in the urine within 24 hours; 82% is excreted from the body within the first 8 hours. Ceftazidime levels in the urine are high. Biliary excretion of the drug is low (less than 1%), but the level in bile exceeds the MIC for some pathogens. Resistance to ceftazidime is caused by chromosomal mutation or acquisition of R-plasmids. The permeability of the antibiotic may be reduced or the structure of the PBP may be altered. Resistance to ceftazidime can rarely be caused by hydrolysis by beta-lactamases.

​

Instructions for use
The drug is recommended for the treatment of infections caused by sensitive strains of some pathogenic microorganisms:

- Infections caused by a single agent

- Mixed infections caused by 2 or more pathogens
- Severe infections, including nosocomial infections: septicemia, bacteremia, peritonitis, meningitis, respiratory infections in immunocompromised patients, infected burns 
- Respiratory tract infections and infections in patients with cystic fibrosis 
- Infections of ENT organs
- Urinary tract infections 
- Skin and soft tissue infections 

- Bone and joint infections 

- MBT, gallbladder and   biliary tract, abdominal infections

- Prevention of infectious complications after surgery performed on various organs (mainly, transurethral resection of the prostate gland)

- Infections caused by hemodialysis  

- Ambulatory peritoneal dialysis (CAPD)

​

Contraindications:

Hypersensitivity to ceftazidime or any of the drug's auxiliary substances or other cephalosporin group antibiotics, penicillin, monobactam and carbapenem. It should be prescribed with caution to kidney failure, MBT diseases, pregnancy, lactation, and newborns. 

Use during pregnancy and lactation: Ceftem crosses the placenta and can be detected in amniotic fluid. Ceftazidime should be used with caution during pregnancy only after a risk-benefit assessment. Ceftazidime is excreted in human milk in small concentrations.

​

Method of use and dosage
The dose is determined individually depending on the severity of the disease, localization, the type of pathogen and its sensitivity to the drug, the patient's age and kidney function. 
Ceftem is used intravenously or deep intramuscularly. 
The daily dose is from 1 g to 6 g. This dose is divided into 2-3 doses and is injected intravenously or intravenously.

​

Adults and adolescents over 14 years of age:In most infections, the recommended daily dose is 1 g every 8 hours or 2 g IV or IV every 12 hours. 500 mg or 1 g is applied every 12 hours in urinary tract and moderately severe infections. In very severe infections, especially in immunocompromised, neutropenic patients, 2 g every 8 or 12 hours, 3 g every 12 hours   are injected. In the case of fibrosis-cystic pseudomonal infections of the lungs (with normal kidney function), a dose of 100 to 150 mg/kg is applied by dividing it into 3 doses during the day. A dose of 9 g/day was used for patients with normal kidney function. For the prevention of prostate surgery, 1 g of ceftazidime  must be injected during induction of anesthesia. A second dose can be administered at the time of catheter removal.

​

Children and infants over 2 months: the recommended daily dose is 30 to 100 mg per kg of body weight divided into 3 times a day every 8 hours. In children with cystic fibrosis, meningitis and immunodepression, the daily dose of ceftazidime can be increased up to 150 mg per kg of body weight (not more than 6 g of ceftazidime per day) by dividing it into 3 times.

Newborns and infants up to 2 months: the recommended daily dose is 25-60 mg per kg of body weight divided into 2 doses per day

Elderly patients, especially over 80 years of age: As creatinine clearance is lower in elderly patients, the dose of ceftazidime daily

It should not exceed 3 g.

Patients with renal failure: dose reduction is required.

​

Preparation of injection solution

Volume and concentration to be added for small doses

​

 

​

​

​

Ceftem can be prescribed deep intramuscularly or intravenously.

Water for injection should be used as a solvent when injecting A/D. As other solvents for IV injection: 0.5% or 1% lidocaine solution can be used. A/d injection should be administered in the upper outer quadratus of the large muscle or in the lateral area of the thigh.
Ceftazidime solution can be injected directly into a vein. If necessary, large doses v/d injection (in bolus) 3-5 min. can be injected during Water for injection is used as a diluent during V/D administration.

A/D injection: Inject the diluent solution into the vial (3ml solution for 1g Ceftem) and shake to dissolve. The solution should become transparent within 1-2 minutes. As ceftazidime powder dissolves, carbon dioxide is released and pressure builds up inside the vial. To normalize the pressure, the degassing needle should be inserted into the rubber plug and removed before the injection solution is withdrawn. Press the plunger of the syringe all the way down. Invert the vial, then insert the needle into the rubber stopper. Make sure the needle stays in the solution and withdraw the contents of the vial as usual. The drawn solution may contain carbon dioxide bubbles, which must be removed from the syringe before injection.

V/D injection: Inject 10 ml (for 1 g and 2 g doses) of the diluent into the vial and shake to dissolve. The solution should become transparent within 1-2 minutes. When the antibiotic dissolves, carbon dioxide is released and pressure builds up inside the vial. Insert the needle to relieve the pressure in the vial. The solution should be used immediately after preparation. Otherwise, any additional pressure that may build up inside the vial must be released before administration to the patient.

​

Side effects:

To the digestive system: diarrhea, nausea, abdominal pain, transient elevation of ALT, AST, LDH, very rarely jaundice.

In skin and soft tissue: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, rarely – itching, urticarial rash, angioedema, toxic epidermal necrolysis.

In CNS and peripheral ss: headache, dizziness.

In the urinary system: transient elevation of blood urea, urea nitrogen and/or creatinine, renal dysfunction.

Local reactions: phlebitis or thrombophlebitis during v/d injection; a/d pain, burning, thickening in the injection area during injection.

Release form

1 g of powder, in a vial of 20 ml, sealed with an aluminum cap equipped with a rubber stopper, a polypropylene disc. 10 ml of water for injection in an ampoule.

1 vial of powder (20 ml) and 1 ampoule (10 ml) are packed in a cardboard box with an insert.

​

Store condition:

It should be stored in a dry, dark place at a temperature not higher than 30ºС. Do not freeze.

​

Manufacturer: Maksur Laboratories Ltd.