GMP Certified / Ceftazidime and Avibactam Sodium for Injection 2.5g

• Quality Standard: USP, Bp
• Factory Certified: GMP
• Ctd Status: Available
• Transport Package: Sea Transportation
• Specification: 2.5g
• Trademark: Sinolead
• Model NO.: injection
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description
 

Generic name	Ceftazidime and Avibactam Sodium for Injection
Strength	2.5g
Standard	BP
Shelf life	2 years
Packing form	10 vials/box

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Ceftazidime and Avibactam Sodium for Injection

Character:
This product is white to light yellow powder.

Indications:
1. Complex intra abdominal Infections (cIAI) This product is indicated for the treatment of complex intra abdominal infections in patients aged 18 years and older caused by the following gram-negative bacteria that are sensitive to this product: Escherichia coli, Klebsiella pneumoniae, Proteus flavus, Enterobacter cloacae, Klebsiella acidogenes, Citrobacter Fredii complex and Pseudomonas aeruginosa. 2. Hospital-acquired pneumonia and ventilator-associated pneumonia (HAP/VAP) This product is indicated for the treatment of hospital-acquired pneumonia and ventilator-associated pneumonia in patients 18 years of age and older caused by the following Gram-negative bacteria sensitive to this product: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa and Haemophilus influenzae. 3. In adult patients with limited treatment options, treat infections caused by the following gram-negative bacteria sensitive to this product: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Proteus mirabilis, and Pseudomonas aeruginosa. This indication is based on the experience of ceftazidime alone and the analysis of the pharmacokinetics-pharmacodynamics relationship of ceftazidime/avibactam. Only physicians with extensive experience in the treatment of infectious diseases should use this product for the treatment of this indication. In order to reduce the appearance of resistant bacteria and maintain the effectiveness of this product and other antimicrobial agents, this product should only be used to treat infections that are confirmed or highly suspected to be caused by sensitive bacteria. Drugs should be selected or adjusted based on new culture and drug susceptibility results. In the absence of such data, local epidemiology and drug resistance analysis may help empirically select treatments.

Pharmacology and toxicology:
Pharmacological action 1) Mechanism of action Ceftazidine combined with penicillin-binding protein (PBPs) can inhibit the synthesis of peptidoglycan in bacterial cell wall, leading to cell lysis and death. Avibactam is a non-β-lactam beta-lactamase inhibitor that acts by forming a covalent admixture with the enzyme that is not easily hydrolyzed. Abvibactam inhibits the AmblerA and C β-lactam channels and certain D β-lacamases, including ultra-broad spectrum β-lacamases (ESBLs), KPC and 0XA-48 carbapenenases, and AmpC enzymes. Avibactam does not inhibit class B enzymes (metal-beta-lactamases) and does not inhibit many class D enzymes. 2) The mechanisms of bacterial resistance that may affect ceftazidime/abvibatam include reduced outer membrane permeability of mutated or acquired penicillin-binding protein, active efflux mechanism, and β-lactamase resistance to abvibatam inhibition leading to ceftazidime hydrolysis. Genotoxicity: The mutagenicity of ceftazidime and avibactam was evaluated in multiple in vitro and in vivo trials. Ceftazidime was negative in Ames test and mouse micronucleus test. Averbactam was negative in Ames test, extra-programmed DNA synthesis test, chromosome aberration test and micronucleus test. Reproductive toxicity: In reproductive studies of ceftazidime mice and rats given doses up to 40 times the human dose, no toxicity of ceftazidime to fetuses was found. The rats given 1000 mg/kg/ day of avibactam (about 20 times the recommended dose for human clinical use based on body surface area) had no effect on the fertility of rats. Female rats given intravenous doses of 500mg/kg and higher of avibactam two weeks before mating showed dose-dependent early pregnancy effects, such as a mild increase in pre - and post-implantation loss and a decrease in litter number. No teratogenic effect of avibactam was observed in rats or rabbits. From 6 to 17 days after conception, intravenous administration of avibactam 0, 250, 500, and 1000 mg/kg/ day showed no embryo-fetal toxicity at doses up to 1000 mg/kg/ day (about 9 times the human dose in terms of AUC). In perinatal toxicity studies in rats, intravenous infusion of avirbactam up to 825 mg/kg/ day (11 times the human exposure in AUC) had no effect on the growth and survival of pups. A dose-dependent increase in the incidence of renal pelvis and ureteral dilation was observed in female litters, but was not associated with pathological changes in renal parenchyma or renal function, and renal pelvis dilation continued until the female litters became adult rats. The results of intravenous administration of averbactam 0, 100, 300, and 1000mg/kg/ day of gestation in rabbits from day 6 to 19 showed that 100mg/kg/ day (AUC is twice the human exposure) had no effect on embryo-fetal development. Higher doses were associated with increased postimplantation loss, lower mean fetal weight, delayed ossification of multiple bones, and other abnormalities.

Storage:
Keep away from light, sealed and not more than 30°C.