Sundent Pharmaceutical Co., Ltd.  

Product Name: GMP Cefazolin Sodium for Injection 0.5g 1g Drug Ad Approval No.: Available Drug Reg./Approval No.: Available Pharmaceutical Technology: Chemical Synthesis Type: Biological Products Shape: Powder State: Solid Suitable for: Adult Usage Mode: IV Im Application: Internal Medicine Certification: GMP Standard: Bp Cp OEM: Available Shelf Life: 3 Years Trademark: Sundent Transport Package: 10vials/Box, 50vials/Box Specification: 0.25g, 0.5g, 1g Origin: China HS Code: 3004909099 Product Description Cefazolin Sodium InjectionIndications: This product is suitable for the treatment of sensitive bacteria caused by otitis media, bronchitis, pneumonia and other respiratory infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, sepsis, infective endocarditis, hepatobiliary system infections and eye ,ear, nose, throat and other infections. This product can also be used as apreventive drug before surgery. This product is not suitable for central nervous system infections. Chronic urinary tract infections, especially those with abnormal urinary tract anatomy, are less effective. This product is not suitable for the treatment of gonorrhea and syphilis.Usage and dosage:Forslow intravenoususe, intravenous drip or intramuscularuse:Adult1. Common dose, once 0.5 ~1g, 2~ 4times aday, serious infections can increase to 6g aday, 2~ 4times intravenously.2. Prevention of surgical infection, the general preoperative 0.5 ~1 hour intramuscular or intravenous 1g, surgery time of more than 6hours, 0.5 ~1g intraoperative use, postoperative every 6~ 8hours 0.5 ~1g, Until 24 hours after surgery.3. When the creatinine clearance rate of the renal insufficiency is greater than 50 ml/min, the normal dose can still be administered. When creatinine clearance is 20 to 50 ml/min, 0.5 gevery 8hours; when creatinine clearance is 11 to 34 ml/min, 0.25 gevery 12 hours; when creatinine clearance is less than 10 ml/min, 0.25 gevery 18 to 24 hours .The first dose was 0.5 gfor all patients with varying degrees of renal insufficiency. When cefazolin was administered to children with renal insufficiency, 12.5 mg/kg was administered first, followed by maintenance dose, and when the creatinine clearance was above 70 ml/min, the normal dose could still be given; creatinine clearance was 40-70 ml/min. For each 12 hours, the body weight is 12.5 to 30 mg/kg; when the creatinine clearance is 20 to 40 ml/min, the body weight is 3.1 to 12.5 mg/kg every 12 hours; when the creatinine clearance rate is 5to 20 ml/min, press every 24 hours. Weight 2.5 to 10 mg/kg.ChildCommon dose: 50 ~100mg/kg on one day, divided into 2~ 3times.Adverse reactions: This product has alow incidence of adverse reactions.1. Intravenous thrombophlebitis and pain in the intramuscular injection area are both less than that of cefotaxime.2. The incidence of drug eruption was 1.1%, and the incidence of eosinophilia was 1.7%, with occasional drug fever.3.Individual patients may have transient serum aminotransferases, elevated alkaline phosphatase.4. Encephalopathy may occur in patients with impaired renal function when using high doses (12g per day).5. Candida albicans double infection occasionally.Precaution:1. Be sensitive to allergies or allergies to penicillin.2. about 1% of drug users can have direct and indirect Coombs test positive and urine false positive reaction (copper sulfate method)..Product fotoOur factoryThis product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries'MOH.Our ServiceWe can specially develop the products per customers' specification.We can offer OEM service with customers' private brands and labels.We can offer excellent after-sale service and professional technical support.Our Quality control systemIn manufacturing, quality is what sustains our life. Starting from the material selection, there are many factors that contribute to the quality control process. Our manufacturing facility isGMPcertified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.Our Quality Control System is outlined below:Initial inspection (such as raw material, excipients, package materials, etc.)In-process inspection (make sure that each testing items should be qualified )Final inspection before shipment of each order.Provide temperature control recorder when it is necessary for special market before loading.Our Registration Team and technical supportWe have experienced team to provide qualified and professional registration documents for most of countries. Up to present, we have registered more than hundred products and exported to more than 20 countries. Especially including those in Asia, Africa, South America, Middle east area and East Europe.We can provide regulatory documentsGMP Certificate /CE CertificateFree sales certificateCertificate of Pharmaceutical ProductsManufacture LicenseCTD Dossier.