Product Name: Cefotaxime Sodium for Injection with GMP Model NO.: 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: I.V. Application: Internal Medicine Certification: GMP Standard: Bp USP 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 Cefotaxime sodium for InjectionIndicationIt is suitable for pneumonia caused by sensitive bacteria and other lower respiratory tract infection, urinary tract infection, meningitis, septicaemia, abdominal infection, pelvic infection, skin soft tissue infection, genital infection, bone and joint infection, etc. Cefotaxime can be used as adrug for children with meningitis.Usage and DosageAdults were given 2to 6G daily, 2~3 times intravenously or intravenously, and those with severe infection were 2to 3G every 6~8 hours, and the highest dose was not more than 12g per day. Treatment of no complications of pneumococcal pneumonia or acute urinary tract infection, every 12 hours 1g. The neonates whose age is less than or equal to 7days is 50mg/kg every 12 hours, and those who are born more than 7days are 50mg/kg every 8hours. The dosage of meningitis can be increased to 75mg/kg every 6hours. Patients with severe renal insufficiency should be appropriately reduced when applying this product. When serum creatinine is above 424 micron mol/L (4.8mg) or creatinine clearance is below 20ml/, the maintenance amount of this product should be reduced by half.Adverse Reactions The incidence of adverse reactions was low, about 3% to 5%.1. there are rashes and drug fever, phlebitis, diarrhea, nausea, vomiting, loss of appetite and so on.2. alkaline phosphatase or serum aminotransferase were slightly elevated, transient blood urea nitrogen and creatinine increased.3. leukocytopenia, acidic granulocytosis, or thrombocytopenia are rare.4. Isaw headache, numbness, dyspnea and facial flushing.Mucous candidiasis can occur in asmall number of 5patients.ContraindicationThis product is contraindicated to them who has cephalosporin allergy and penicillin anaphylactic shock or immediate reaction history.Precautions 1. before medication, an allergy test should be carried out.2. cross anaphylaxis: allergic to acephalosporin or cephalosporin may also be allergic to other cephalosporins or cephalosporins. Allergic to penicillin or penicillamine may also be allergic to this product.3. interference with diagnosis: anti globulin (Coombs) test can be positive in patients who use this product, and this product can appear in newborns before pregnancy. The determination of urine sugar by copper sulfate can be false positive. Serum alkaline phosphatase, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase or serum lactate dehydrogenase can be increased.4. cefotaxime sodium 1.05g is equivalent to 1g cefotaxime, and the sodium content per 1g cefotaxime sodium is about 2.2mmol (51mg). 1g cefotaxime was dissolved in Sterile Water for Injection 14ml to form isotonic solution.5. when preparing intramuscular injection, cefotaxime 0.5g, 1.0g or 2.0g were added to 2ml, 3ml or 5ml Sterile Water for Injection respectively. For intravenous injection, at least 10 ~20ml of Sterile Water for Injection was slowly injected into the above different cefotaxime within 5~10 minutes. When intravenous drip, the intravenous injection should be diluted to 100 to 500ml with suitable solvent. Injection of different parts should be injected when the intramuscular injection exceeds 2G.6. patients with renal dysfunction should be cautious in reducing dosage; those with gastrointestinal diseases or renal dysfunction should be cautious.7. this product and aminoglycoside can not be instilled in the same bottle.Precautions for pregnancy and lactation:Breast-feeding women should use it carefully.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 is GMP certified. 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.Technical Supportregulatory documentsYesGMP Certificate /CE CertificateYesFree sales certificateYesCertificate of Pharmaceutical ProductsYesManufacture LicenseYesCTD DossierYes
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